*Please see amendment for Pennsylvania Medicaid at the end

Transcription

1 1 of 38 Number: 0526 Policy *Please see amendment for Pennsylvania Medicaid at the end of this CPB. Notes: Aetna s standard traditional plans (Managed Choice POS, PPO, and indemnity) cover medically necessary surgical dressings only when prescribed by a physician and supplied by a home care agency in conjunction with covered home health care services or when dispensed and used by a participating health care provider in conjunction with treatment of the member. Under Aetna traditional plans, supplies are not covered when they do not require a prescription and can be purchased by the member overthe counter or when they are given to the member as take home supplies. Please check benefit plan descriptions. Aetna s standard HMO plans cover surgical dressings when they are medically necessary for wound debridement or for the treatment of a wound caused by, or treated by, a surgical procedure. Please check benefit plan descriptions. Last Review 05/25/2017 Effective: 07/03/2001 Next Review: 05/24/2018 Review History Definitions Clinical Policy Bulletin Notes Covered surgical dressings include both medically necessary primary dressings (i.e., therapeutic or protective coverings applied directly to wounds or lesions either on the skin or caused by an opening to the skin) and medically necessary secondary

2 2 of 38 dressings (i.e., materials that serve a therapeutic or protective function and that are needed to secure a primary dressing). Items such as adhesive tape, roll gauze, or elastic bandages are examples of secondary dressings. Elastic stockings, support hose, foot coverings, leotards, knee supports, surgical leggings, gauntlets, and pressure garments for the arms and hands are examples of items that are not ordinarily covered as surgical dressings. Debridement: Note: Debridement of a wound may be any type of debridement, including surgical (e.g., sharp instrument or laser), mechanical (e.g., irrigation or wet to dry dressings), chemical (e.g., topical application of enzymes), or autolytic (e.g., application of occlusive dressings to an open wound). Medically necessary dressings used for mechanical debridement, to cover chemical debriding agents, or to cover wounds to allow for autolytic debridement are covered under both HMO and traditional plans under the surgical dressings benefit, although the chemical debriding agents themselves, if self administered, are covered under the pharmacy benefit. Dressings over a percutaneous catheter or tube: Note: Under all plans, medically necessary dressings over a percutaneous catheter or tube (e.g., intravascular, epidural, nephrotomy, etc.) are covered as long as the catheter or tube remains in place and after removal until the wound heals. Non covered dressings: Examples of situations in which dressings are of no proven benefit because of insufficient evidence in the peer reviewed literature include the following: 1. A first degree burn; 2. A stage I pressure ulcer; 3. A venipuncture or arterial puncture site (e.g., blood sample) other than the site of an indwelling catheter or needle; 4. Drainage from a cutaneous fistula which has not been caused

3 3 of 38 by or treated by a surgical procedure; 5. Wounds caused by trauma that do not require surgical closure or debridement (e.g., skin tear or abrasion). Wound covers: Wound covers are flat dressing pads. A wound cover with adhesive border is one that has an integrated cover and distinct adhesive border designed to adhere tightly to the skin. When a wound cover with an adhesive border is being used, no other dressing would be used on top of it and additional tape is usually not considered medically necessary. Reasons for use of additional tape should be documented. An adhesive border is usually more binding than that obtained with separate taping and is therefore considered medically necessary for use with wounds requiring less frequent dressing changes. Note on wound care items not covered under the surgical dressings benefit: The following are examples of wound care items which would not be covered under the surgical dressings benefit: Enzymatic debriding agents, Gauze or other dressings used to cleanse or debride a wound but not left on the wound, Skin sealants or barriers, Solutions used to moisten gauze (e.g., saline), Topical antibiotics, Topical antiseptics, Wound cleansers or irrigating solutions. If medically necessary and available by prescription, some of these items may be covered under the pharmacy benefit if ordered by a physician. Quantity of surgical dressings: The medically necessary quantity and type of dressings dispensed at any one time must take into account the current status of the

4 4 of 38 wound(s), the likelihood of change, and the recent use of dressings. Dressing needs may change frequently (e.g., weekly) in the early phases of wound treatment and/or with heavily draining wounds. Suppliers are also expected to have a mechanism for determining the quantity of dressings that the person is actually using and to adjust their provision of dressings accordingly. No more than a 1 month's supply of dressings is considered medically necessary at one time, unless there is documentation to support the medical necessity of greater quantities in the home setting in an individual case. An even smaller quantity may be appropriate in the situations described above. Surgical dressing kits: A surgical dressing kit is defined as non individualized, standardized packaging containing repetitive quantities of dressings not related to the individual medical needs of a member, or whose contents have not each been prescribed for the care of the specific wounds of that member, or that contain materials in addition to surgical dressings. Surgical dressings must be tailored to the specific needs of an individual member. This can not be accomplished when dressings are provided as kits or trays containing fixed quantities and/or multiple types of dressings. When surgical dressing kits are used for the provision of surgical dressings, all components of the kit will be considered not medically necessary. Wound fillers: Wound fillers are dressing materials that are placed into open wounds to eliminate dead space, absorb exudate, or maintain a moist wound surface. Wound fillers come in hydrated forms (e.g., pastes, gels), dry forms (e.g., powder, granules, beads), or other forms (e.g., rope, spiral, pillows, etc). Products containing multiple materials are categorized according to the clinically predominant component (e.g., alginate, foam, gauze, hydrocolloid, hydrogel). Other multi component wound

5 5 of 38 dressings not containing these specified components may be classified as composite or specialty absorptive dressings if the definition of these categories has been met. Gauze or gauze like products are typically manufactured as a single piece of material folded into a several ply gauze pad. Use of more than one type of wound filler or more than one type of wound cover in a single wound is rarely considered medically necessary. It may not be considered medically necessary to use some combinations of a hydrating dressing on the same wound at the same time as an absorptive dressing (e.g., hydrogel and alginate). Because composite dressings, foam and hydrocolloid wound covers, and transparent film, when used as secondary dressings, are meant to be changed at frequencies less than daily, appropriate clinical judgment should be used to avoid their use with primary dressings which would require more frequent dressing changes. For these dressings, changes greater than once every other day are not considered medically necessary. While a highly exudative wound might require such a combination initially, with continued proper management the wound should progress to a point where the appropriate selection of these products should result in the less frequent dressing changes which they are designed to allow. An example of a combination that would be considered not medically necessary is the use of a specialty absorptive dressing on top of non impregnated gauze being used as a primary dressing. Dressing size should be based on and appropriate to the size of the wound. For wound covers, the medically necessary pad size should usually be about 2 inches greater than the dimensions of the wound. For example, a 5 cm X 5 cm (2 in. X 2 in.) wound would require a 4 in. X 4 in. pad size. The following are some specific medical necessity guidelines for individual products when the products themselves are considered medically necessary in the individual member. The medical necessity for more frequent change of dressing should be documented in the member's medical record. Alginate or other fiber gelling dressing:

6 6 of 38 Alginate or other fiber gelling dressing covers are considered medically necessary for moderately to highly exudative full thickness wounds (e.g., stage III or IV ulcers); and alginate or other fiber gelling dressing fillers for moderately to highly exudative full thickness wound cavities (e.g., stage III or IV ulcers). They are of no proven benefit on dry wounds or wounds covered with eschar. Up to 1 dressing change per day is considered medically necessary, unless the medical necessity of more frequent changes is documented. One wound cover sheet of the approximate size of the wound or up to 2 units of wound filler (1 unit = 6 inches of alginate or other fiber gelling dressing rope) would be considered medically necessary for each dressing change, unless the medical necessity for more wound cover or filler is documented. It is usually not considered medically necessary to use alginates or other fiber gelling dressings in combination with hydrogels. Composite dressing: Composite dressings are products combining physically distinct components into a single dressing that provides multiple functions. These functions must include, but are not limited to: (a) a bacterial barrier, (b) an absorptive layer other than an alginate, foam, hydrocolloid, or hydrogel, (c) either a semiadherent or non adherent property over the wound site, and (d) an adhesive border. Up to 3 composite dressing changes per week are considered medically necessary, 1 wound cover per dressing change, unless it is documented that more frequent changes are medically necessary. Amino acid dressings: Amino acid dressings are considered experimental and investigational for the management of chronic wounds because of insufficient evidence in the peer reviewed literature. Contact layer: Contact layers are thin non adherent sheets placed directly on an open wound bed to protect the wound tissue from direct contact

7 7 of 38 with other agents or dressings applied to the wound. They are porous to allow wound fluid to pass through for absorption by an overlying dressing. Contact layer dressings are used to line the entire wound; they are not intended to be changed with each dressing change. Up to 1 contact layer dressing change per week is considered medically necessary, unless it is documented that more frequent changes are medically necessary. Foam dressing: Foam dressings are considered medically necessary when used on full thickness wounds (e.g., stage III or IV ulcers) with moderate to heavy exudate. Usual dressing change for a foam wound cover used as a primary dressing is up to 3 times per week. When a foam wound cover is used as a secondary dressing for wounds with very heavy exudate, dressing changes may be medically necessary up to 3 times per week. Up to 1 dressing change for foam wound fillers per day is considered medically necessary, unless it is documented that more frequent changes are medically necessary. Ibuprofen foam dressings for painful venous leg ulcers are considered experimental and investigational because they have not been shown to be more effective than standard foam dressings. Gauze, non impregnated: For a dressing without a border, up to 3 non impregnated gauze dressing changes per day are considered medically necessary, unless there is documentation that more frequent changes are medically necessary. For dressing changes with a border, 1 change per day is considered medically necessary, unless more frequent changes are medically necessary. It is usually not considered medically necessary to stack more than 2 gauze pads on top of each other in any one area. Gauze, impregnated, other than water or normal saline, hydrogel, or zinc paste: Note: Impregnated gauze dressings are woven or non woven materials in which substances such as iodinated agents,

8 8 of 38 petrolatum, zinc compounds, crystalline sodium chloride, chlorhexadine gluconate (CHG), bismuth tribromophenate (BTP), water, aqueous saline, or other agents have been incorporated into the dressing material by the manufacturer. However, when the dressing and the substance with which it is impregnated are listed in combination in the Food and Drug Administration (FDA) Orange Book (e.g., an antibiotic impregnated dressing which requires a prescription), then the entire item is considered a drug which would be covered under the pharmacy benefit if selfadministered, ordered by a physician and available by prescription. Up to 1 dressing change per day is considered medically necessary for gauze dressings impregnated with other than water, normal saline, hydrogel, or zinc paste, unless there is documentation that more frequent changes are medically necessary. Gauze, impregnated, water or normal saline: There is no medical necessity for these dressings compared to non impregnated gauze, which is moistened with bulk saline or sterile water. Note: Bulk saline or sterile water is not covered. Hydrocolloid dressing: Hydrocolloid dressings are considered medically necessary for use on wounds with light to moderate exudate. Up to 3 dressing changes per week are considered medically necessary for hydrocolloid wound covers or hydrocolloid wound fillers, unless it is documented that more frequent changes are medically necessary. Hydrogel dressing: Hydrogel dressings are considered medically necessary when used on full thickness wounds with minimal or no exudate (e.g., stage III or IV ulcers). Hydrogel dressings are typically of no proven benefit for stage II ulcers. Documentation must substantiate the medical necessity for use of hydrogel dressings

9 9 of 38 for stage II ulcers (e.g., location of ulcer is sacro coccygeal area). For hydrogel wound covers without adhesive borders or hydrogel wound fillers, up to 1 dressing change per day is considered medically necessary, unless it is documented that more frequent dressing changes are medically necessary. For hydrogel wound covers with adhesive borders, up to 3 dressing changes per week are considered medically necessary, unless it is documented that more frequent changes are medically necessary. The medically necessary quantity of hydrogel filler used for each wound should not exceed the amount needed to line the surface of the wound. Additional amounts used to fill a cavity are not considered medically necessary. Documentation must substantiate the medical necessity for hydrogel filler billed in excess of 3 units (fluid ounces) per wound in 30 days. Use of both a hydrogel filler and a hydrogel cover on the same wound at the same time is of no proven benefit. Specialty absorptive dressing: Specialty absorptive dressings are unitized multi layer dressings which provide (a) either a semi adherent quality or non adherent layer, and (b) highly absorptive layers of fibers such as absorbent cellulose, cotton, or rayon. These may or may not have an adhesive border. Specialty absorptive dressings are considered medically necessary when used for moderately or highly exudative wounds (e.g., stage III or IV ulcers). Up to 1 change of specialty absorptive dressing per day is considered medically necessary for a dressing without an adhesive border, and up to 1 dressing change every other day is considered medically necessary for a dressing with a border, unless it is documented that more frequent changes are medically necessary. Transparent film: Transparent film dressings are considered medically necessary when used on open partial thickness wounds with minimal exudate or closed wounds. Up to 3 transparent film dressing changes per week are considered medically necessary, unless it is

10 10 of 38 documented that more frequent dressing changes are medically necessary. Wound filler, not elsewhere classified: Up to 1 dressing change per day is considered medically necessary, unless it is documented that more frequent changes are needed. Wound pouch: A wound pouch is a waterproof collection device with a drainable port that adheres to the skin around a wound. Up to 3 dressing changes per week are considered medically necessary, unless the medical necessity of more frequent changes is documented. Tape: Tape is considered medically necessary to hold on a wound cover, elastic roll gauze or non elastic roll gauze. Additional tape is usually not considered medically necessary when a wound cover with an adhesive border is used. The medical necessity for tape in these situations should be documented. The medically necessary frequency of tape change is determined by the frequency of change of the wound cover. Quantities of tape submitted should reasonably reflect the size of the wound cover being secured. The following amounts of tape are considered medically necessary, unless the medical necessity of additional tape is documented: for wound covers measuring 16 square inches or less, up to 2 units per dressing change is considered medically necessary; for wound covers measuring 16 to 48 square inches, up to 3 units per dressing change is considered medically necessary; for wound covers measuring greater than 48 square inches, up to 4 units per dressing change is considered medically necessary. Elastic bandage: Elastic bandages are considered medically necessary when used as a secondary dressing to hold wound cover dressings in place.

11 11 of 38 When an elastic bandage is used over a wound cover with adhesive border or over a wound cover which is held in place by tape, elastic roll gauze or non elastic roll gauze, or transparent film, the elastic bandage is of no proven benefit. Elastic bandages have also not been proven useful for strains, sprains, edema, or situations other than as a secondary surgical dressing. Most elastic bandages are reusable. No more than 1 replacement per week is considered medically necessary, unless the medical necessity of more frequent replacements is documented. Gauze, elastic: The medically necessary frequency of elastic gauze dressing changes is determined by the frequency of changes of the selected primary dressing. Overlying elastic gauze is of no proven benefit when a dressing is secured with tape or has an adhesive border. Gauze, non elastic: The medically necessary frequency of non elastic gauze dressing changes is determined by the frequency of change of the selected primary dressing. Overlying non elastic gauze is of no proven benefit when a dressing is secured with tape or has adhesive border. Tissue adhesives, tissue sealants, hemostatic agents: The use of tissue adhesives, tissue sealants or hemostatic agents as an alternative to sutures in wound closure is considered integral to the surgical procedure and not separately reimbursed. Light Compession Bandage, Moderate/High Compression Bandage, Self Adherent Bandage, Conforming Bandage, Padding Bandage: Most compression bandages are reusable. Usual medically necessary frequency of replacement would be no more than one per week unless they are part of a multi layer compression

12 12 of 38 bandage system. The medical necessity of conforming bandage dressing change is determined by the frequency of change of the selected underlying dressing. Gradient Compression Wrap: A gradient compression stocking or a non elastic gradient compression wrap is considered medically necessary when it is used in the treatment of an open venous stasis ulcer. The medically necessary frequency of a non elastic gradient compression wrap is limited to one per 6 months per leg. Quantities exceeding this amount will be denied as not medically necessary. Notes on relationship with other policies: Under both HMO and traditional plans, charges for disposable supplies and accessories may also be covered when required to operate durable medical equipment or prosthetic devices (e.g., tracheostomy supplies, urologic supplies, ostomy supplies, dialysis supplies, etc.). Background This policy is based in part upon Medicare DMERC criteria. In a prospective, observational study, Cassino and Ricci (2010) examined if the topical application of an amino acid dressing, Vulnamin, aids the management of chronic wounds. A total of 160 patients with non infected cutaneous chronic wounds were recruited. Before treatment, wound size was assessed using digital planimetry. Treatment lasted for a maximum of 6 weeks. Wound area measurements were repeated 2 and 6 weeks after starting treatment. There was a significant reduction in the mean wound area after 2 weeks (7.4 +/ 8.7 cm2) and 6 weeks (4.6 +/ 6.3 cm2) of treatment, when compared with baseline (11.2 +/ 12.1 cm2, p < 0.01). At the final follow up, 23 % of patients (n = 36) healed and 34 % (n = 54) achieved a greater than 60 % reduction in wound size. A total of 76 % (n = 120) of subjects

13 13 of 38 achieved positive outcomes (defined as a greater than 40 % reduction in the ulcer size). The authors concluded that although further investigations on the potential effects of this product on chronic wound healing are needed, these findings suggest amino acid dressings may promote healing in venous, pressure and diabetic ulcers. In a Cochrane review, Briggs and Nelson (2010) evaluated the effectiveness of dressings, local anesthetics or topical analgesia for pain relief in venous leg ulceration. For this update, the search strings were revised and the following databases were searched: The Cochrane Wounds Group Specialised Register (searched 16/12/09) The Cochrane Central Register of Controlled Trials (CENTRAL) The Cochrane Library Issue ; Ovid MEDLINE 1950 to November Week ; Ovid EMBASE 1980 to 2009 Week 50; EBSCO CINAHL 1982 to December No date or language restrictions were applied. Randomized controlled trials (RCTs) that evaluated local interventions used to relieve venous leg ulcer pain were considered. Pain was defined as either persistent pain or pain at dressing changes or debridement. Ulcer healing and reported adverse events were also considered as further outcomes. Eligibility for inclusion was confirmed by 2 review authors who independently assessed the potential trials. Two trials evaluating interventions for persistent venous leg ulcer pain were identified for this review update. Both studies evaluated ibuprofen slow release foam dressings; one comparing it with local best practice and the other with an identical foam comparator. The primary end point for both studies was "pain relief achieved". When compared with a foam dressing alone, there was no evidence of a statistically significant effect of the ibuprofen foam dressing in terms of achieving some pain relief the first evening after treatment: 74 % in the ibuprofen group (46/62) had pain relief compared with 58 % (35/60) in the foam group (no significant difference: relative risk [RR] 1.27, 95 % confidence interval (CI): 0.98 to 1.65). In the second study 100 % (32/32) of people with venous ulcers achieved some pain relief with the ibuprofen dressing on the first evening of treatment compared with 93 % (26/28) in the local best practice group (no significant difference: RR 1.08, 95 % CI: 0.96 to 1.21). Pooling these studies in a meta analysis (using a random effects model as

14 14 of 38 significant heterogeneity present (p = 0.1), I(2) = 64 %) there is no evidence that ibuprofen dressings increase the pain relief experienced by the first evening of use (RR 1.15, 95 % CI: 0.91 to 1.44). These investigators were unable to extract sufficient data to combine other pain outcomes from these trials. There was no difference in healing rates but slightly more adverse events with ibuprofen dressings than with a similar foam dressing without ibuprofen. Six trials evaluated interventions for the pain associated with debridement and were considered sufficiently similar to pool. There was a statistically significant reduction in debridement pain scores with 5 % eutectic mixture of local anesthetics (EMLA): lidocaine prilocaine cream; the difference in means (measured on a 100 mm scale) was 20.6 mm (95 % CI: to 29.11). Of these 6 trials, only 1 small trial measured healing as an outcome and found no difference in the numbers of ulcers healed at the end of the study. The authors concluded that there is no evidence that ibuprofen dressings offer pain relief, as measured at the first evening of use, to people with painful venous leg ulcers compared with foam dressings or best practice. Eutectic mixture of local anesthetics appears to provide effective pain relief for venous leg ulcer debridement but the effect (if any) of EMLA on ulcer healing remains unknown. In a Cochrane review, Coulthard et al (2010) examined the relative effects of various tissue adhesives and conventional skin closure techniques on the healing of surgical wounds. These investigators searched the Cochrane Wounds Group Specialised Register (searched 17/11/09); the Cochrane Central Register of Controlled Trials (CENTRAL) the Cochrane Library Issue ; Ovid MEDLINE 1950 to November Week ; Ovid EMBASE 1980 to 2009 Week 46; EBSCO CINAHL 1982 to 17 November No date or language restrictions were applied. Only RCTs were eligible for inclusion. Screening of eligible studies and data extraction were conducted independently and in triplicate while assessment of the methodological quality of the trials was conducted independently and in duplicate. Results were expressed as random effects models using mean difference for continuous outcomes and relative risks with 95 % CI for dichotomous outcomes. Heterogeneity was investigated including both clinical and methodological factors. This update

15 15 of 38 identified an additional 6 trials resulting in a total of 14 RCTs (1,152 patients) which met the inclusion criteria. Sutures were significantly better than tissue adhesives for minimising dehiscence (10 trials). Sutures were also found to be significantly faster to use. For all other analyses of infection, patient and operator satisfaction and cost there was no significant difference between sutures and tissue adhesives. No differences were found between tissue adhesives and tapes (2 trials) for minimising dehiscence, infection, patients assessment of cosmetic appearance, patient satisfaction or surgeon satisfaction. However a statistically significant difference in favor of using tape was found for surgeons' assessment of cosmetic appearance (mean difference 13, 95 % CI: 5 to 21). Tapes were also demonstrated to be significantly faster to use than tissue adhesives as were staples (1 trial). No other outcome measures were analysed in this group. One trial compared tissue adhesives with a variety of methods of wound closure and found both patients and clinicians were significantly more satisfied with the alternative closure methods than the adhesives. In this same trial, tissue adhesives were significantly less time consuming to use. For the remaining outcomes of dehiscence and infection no difference was observed between groups. This trial also compared high viscosity with low viscosity adhesives and found that high viscosity adhesives were less time consuming to use than low viscosity tissue adhesives. For all other outcomes of dehiscence, infection, patient satisfaction and operator satisfaction there was no statistically significant difference between high and low viscosity adhesives. The authors concluded that sutures were significantly better than tissue adhesives for minimizing dehiscence and were found to be significantly faster to use. Although surgeons may consider the use of tissue adhesives as an alternative to other methods of surgical site closure in the operating theater, they must be aware that adhesives may take more time to apply and that if higher tension is needed upon an incision, sutures may minimize dehiscence. The authors stated that there is a need for more well designed RCTs comparing tissue adhesives and alternative methods of closure. These trials should include people whose health may interfere with wound healing and surgical sites of high tension.

16 16 of 38 Lund Nielsen et al (2011) stated that between 5 % and 10 % of cancer patients develop malignant wounds. In vitro and some clinical studies suggest that silver or honey coated dressings may have an anti bacterial effect in non malignant wounds, but their possible anti bacterial effect in malignant wounds remains unknown. A prospective, randomized, single blind, controlled clinical study was conducted to evaluate the bacteriology of malignant wounds and compare the effect of a honey coated (Group A) to a silver coated (Group B) dressing on the qualitative bacteriology of malignant wounds. All wound interventions were performed by the same healthcare professional. Swab cultures were obtained at baseline and following a 4 week intervention and were evaluated without information about the patient treatment group. Of the 75 patients with advanced cancer and malignant wounds identified, 67 (34 in group A, 33 in group B; median age of 64 years, range of 47 to 92) consented to participate and completed the 4 week study. The majority were women (88 %) with breast cancer (79 %). No statistically significant differences were found between the type and number of different wound pathogens in the wounds during the course of the study or between Group A and Group B. Neither antineoplastic nor antibiotic treatment influenced the presence of wound pathogens. Staphylococci were found in 42 %, enteric bacteria in 34 %, anaerobic bacteria in 16 %, Pseudomonas in 10 %, and hemolytic streptococci in 6 % of wounds at baseline; in total, 25 different bacterial species were identified. Sixty one percent (61 %) of wounds decreased in size following treatment, but no significant differences were observed between the type and variety of wound pathogens and whether wound size decreased. Although quantitative bacteriological changes may have occurred, the possible anti bacterial effect of the honey or silver dressing could not be confirmed in these malignant wounds. Routine wound swabbing of malignant wounds is of little value and should be restricted to cases where signs of infection requiring antibiotic intervention are observed or where resistant organisms require special infection control measures. Swan et al (2011) stated that excessive post operative drainage following groin and axillary lymphadenectomy may be associated with a prolonged hospital stay and an increased complication

17 17 of 38 rate. The use of fibrin sealant before wound closure may reduce post operative wound drainage. Consecutive patients undergoing elective groin or axillary lymphadenectomy were randomized to standard wound closure or to having fibrin sealant sprayed on to the wound bed before closure. Post operative wound drainage, duration of drainage and complications were recorded, as were loco regional recurrence, distant metastasis and mortality. A total of 74 patients requiring 38 groin and 36 axillary dissections were randomized. The median post operative wound drainage volume for the groin dissection cohort was 762 (range of 25 to 3,255) ml in the control group and 892 (265 to 2,895) ml in the treatment group (p = 0 704). Drainage volumes in the axillary cohort were 590 (230 to 9,605) and 565 (30 to 1,835) ml in the control and treatment groups respectively (p = 0 217). There was no difference in the duration of drainage or post operative complication rate between the treatment groups in both the axillary and groin cohorts. Local recurrence, distant metastasis and mortality rates did not differ between the treatment groups. The authors concluded that there was no advantage in using fibrin sealant during elective lymphadenectomy in terms of reducing drainage output or post operative complication rate. In a Cochrane review, Dumville et al (2013) compared the effects of hydrocolloid wound dressings with no dressing or alternative dressings on the healing of foot ulcers in people with diabetes. For this first update, in April 2013, these investigators searched the following databases the Cochrane Wounds Group Specialised Register; the Cochrane Central Register of Controlled Trials (CENTRAL) (the Cochrane Library); Ovid MEDLINE; Ovid MEDLINE (in process & other non indexed citations); Ovid EMBASE; and EBSCO CINAHL. There were no restrictions based on language or date of publication. Published or unpublished RCTs that have compared the effects on ulcer healing of hydrocolloid with alternative wound treatments in the treatment of foot ulcers in people with diabetes were selected for analysis. Two review authors independently performed study selection, risk of bias assessment and data extraction. They included 5 studies (535 participants) in the review: these compared hydrocolloids with basic wound contact dressings, foam dressings, alginate dressings and a topical treatment. Meta analysis of 2 studies indicated no

18 18 of 38 statistically significant difference in ulcer healing between fibroushydrocolloids and basic wound contact dressings: RR 1.01 (95 % CI: 0.74 to 1.38). One of these studies found that a basic wound contact dressing was more cost effective than a fibroushydrocolloid dressing. One study compared a hydrocolloid matrix dressing with a foam dressing and found no statistically significant difference in the number of ulcers healed. There was no statistically significant difference in healing between an antimicrobial (silver) fibrous hydrocolloid dressing and standard alginate dressing; an anti microbial dressing (iodine impregnated) and a standard fibrous hydrocolloid dressing or a standard fibrous hydrocolloid dressing and a topical cream containing plant extracts. The authors concluded that currently there is no evidence to suggest that any type of hydrocolloid wound dressing is more effective in healing diabetic foot ulcers than other types of dressing or a topical cream containing plant extracts. Decision makers may wish to consider aspects such as dressing cost and the wound management properties offered by each dressing type (e.g., exudate management). In a Cochrane review, Toon and colleagues (2013) evaluated the risk and benefits of removing a dressing covering a closed surgical incision site within 48 hours permanently (early dressing removal) or beyond 48 hours of surgery permanently with interim dressing changes allowed (delayed dressing removal), on surgical site infection. In July 2013, these investigators searched the following electronic databases: The Cochrane Wounds Group Specialised Register; the Cochrane Central Register of Controlled Trials (CENTRAL) (the Cochrane Library); Database of Abstracts of Reviews of Effects (DARE) (the Cochrane Library); Ovid MEDLINE; Ovid MEDLINE (in process & other non indexed citations); Ovid EMBASE; and EBSCO CINAHL. They also searched the references of included trials to identify further potentially relevant trials. Two review authors independently identified studies for inclusion. They included all RCTs conducted with people of any age and sex, undergoing a surgical procedure, and who had their wound closed and a dressing applied. They included only trials that compared early versus delayed dressing removal; and excluded trials that included people with contaminated or dirty wounds. These researchers also excluded quasi randomized

19 19 of 38 studies, and other study designs. Two review authors independently extracted data on the characteristics of the trial participants, risk of bias in the trials and outcomes for each trial. They calculated RR with 95 % CI for binary outcomes and mean difference (MD) with 95 % CI for continuous outcomes. They used RevMan 5 software to perform these calculations. A total of 4 trials were identified for inclusion in this review. All the trials were at high risk of bias; 3 trials provided information for this review. Overall, this review included 280 people undergoing planned surgery. Participants were randomized to early dressing removal (removal of the wound dressing within the 48 hours following surgery) (n = 140) or delayed dressing removal (continued dressing of the wound beyond 48 hours) (n = 140) in the 3 trials. There were no statistically significant differences between the early dressing removal group and delayed dressing removal group in the proportion of people who developed superficial surgical site infection within 30 days (RR 0.64; 95 % CI: 1.32 to 1.28), superficial wound dehiscence within 30 days (RR 2.00; 95 % CI: 0.19 to 21.16) or serious adverse events within 30 days (RR 0.83; 95 % CI: 0.28 to 2.51). No deep wound infection or deep wound dehiscence occurred in any of the participants in the trials that reported this outcome. None of the trials reported quality of life. The hospital stay was significantly shorter (MD 2.00 days; 95 % CI: 2.82 to 1.18) and the total cost of treatment significantly less (MD EUR 36.00; 95 % CI: to 12.19) in the early dressing removal group than in the delayed dressing removal group in the only trial that reported these outcomes. The authors concluded that early removal of dressings from clean or clean contaminated surgical wounds appears to have no detrimental effect on outcomes. However, it should be noted that the point estimate supporting this statement was based on very low quality evidence from 3 small RCTs, and the CI around this estimate were wide. Early dressing removal may result in a significantly shorter hospital stay, and significantly reduced costs, than covering the surgical wound with wound dressings beyond the first 48 hours after surgery, according to very low quality evidence from 1 small RCT. The authors stated that further RCTs of low risk of bias are needed to examine if dressings are necessary after 48 hours in different types of surgery and levels of contamination and investigate whether antibiotic therapy

20 20 of 38 influences the outcome. In a Cochrane review, Dumville et al (2014) examined the effects of various tissue adhesives compared with conventional skin closure techniques for the closure of surgical wounds. In March 2014 for this second update, these investigators searched the Cochrane Wounds Group Specialised Register; The Cochrane Central Register of Controlled Trials (CENTRAL) (The Cochrane Library); Ovid MEDLINE; Ovid MEDLINE (In Process & Other Non Indexed Citations); Ovid EMBASE and EBSCO CINAHL. They did not restrict the search and study selection with respect to language, date of publication or study setting. Only RCTs were eligible for inclusion. These researchers conducted screening of eligible studies, data extraction and risk of bias assessment independently and in duplicate. They expressed results as random effects models using mean difference for continuous outcomes and RR with 95 % CI for dichotomous outcomes. They investigated heterogeneity, including both clinical and methodological factors. This second update of the review identified 19 additional eligible trials resulting in a total of 33 studies (2,793 participants) that met the inclusion criteria. There was low quality evidence that sutures were significantly better than tissue adhesives for reducing the risk of wound breakdown (dehiscence; RR 3.35; 95 % CI: 1.53 to 7.33; 10 trials, 736 participants that contributed data to the meta analysis). The number needed to treat for an additional harmful outcome was calculated as 43. For all other outcomes infection, patient and operator satisfaction and cost there was no evidence of a difference for either sutures or tissue adhesives. No evidence of differences was found between tissue adhesives and tapes for minimizing dehiscence, infection, patients' assessment of cosmetic appearance, patient satisfaction or surgeon satisfaction. However there was evidence in favor of using tape for surgeons' assessment of cosmetic appearance (mean difference (VAS 0 to 100) 9.56 (95 % CI: 4.74 to 14.37; 2 trials, 139 participants). One trial compared tissue adhesives with a variety of methods of wound closure and found both patients and clinicians were significantly more satisfied with the alternative closure methods than the adhesives. There appeared to be little difference in outcome for different types of tissue adhesives. One study that

21 21 of 38 compared high viscosity with low viscosity adhesives found that high viscosity adhesives were less time consuming to use than low viscosity tissue adhesives, but the time difference was small. The authors concluded that sutures are significantly better than tissue adhesives for minimizing dehiscence. In some cases tissue adhesives may be quicker to apply than sutures. Although surgeons may consider the use of tissue adhesives as an alternative to other methods of surgical site closure in the operating room, they need to be aware that sutures minimize dehiscence. They stated that there is a need for more well designed RCTs comparing tissue adhesives with alternative methods of closure. These trials should include people whose health may interfere with wound healing and surgical sites of high tension. Fungating wounds arise from primary, secondary or recurrent malignant disease and are associated with advanced cancer. A small proportion of patients may achieve healing following surgical excision, but treatment is usually palliative. Fungating wound management usually aims to slow disease progression and optimize quality of life by alleviating physical symptoms, such as copious exudate, malodor, pain and the risk of hemorrhage, through selection of appropriate dressings and topical agents. In a Cochrane review, Adderley and Holt (2014) evaluated the evidence of the effects of dressings and topical agents on quality of life, and symptoms that impact on quality of life, in people with fungating malignant wounds. For this third update, these investigators searched the Wounds Group Specialised Register in August 2013; the Cochrane Central Register of Controlled Trials (CENTRAL) (The Cochrane Library); Ovid MEDLINE; Ovid MEDLINE (In Process & Other Non Indexed Citations); Ovid EMBASE and EBSCO CINAHL. Eligible studies comprised RCTs or, in their absence, controlled clinical trials (CCTs) with a concurrent control group. Data extraction and risk of bias assessment was undertaken by one review author and checked for accuracy by a second. A total of 4 trials involving 164 people were included. One RCT in women with superficial breast lesions compared 6 % miltefosine solution with placebo and found that miltefosine delayed tumor progression. The study reported that the time to treatment failure was significantly longer in the miltefosine group

22 22 of 38 (median of 56 days) than in the placebo group (median of 21 days) (p value 0.007, log rank test). A second trial compared topical metronidazole with placebo but the results up to the point of cross over were not statistically significant. A third trial compared the effect of foam dressings containing silver to foam dressings without silver and found that more patients experienced decreased malodor in the foam with silver group than in the foam alone group (p value=0.049). The fourth trial compared the effect of manuka honey coated dressings with nano crystalline silver coated dressings and found no statistically significant difference with regard to exudate, malodor and wound pain. All trials, however, had methodological limitations. The authors concluded that there is weak evidence from 1 small trial that 6 % miltefosine solution applied topically to people with superficial fungating breast lesions (smaller than 1cm) who have received either previous radiotherapy, surgery, hormonal therapy or chemotherapy for their breast cancer, may slow disease progression. They noted that there is also weak evidence to suggest that foam dressings containing silver may be effective in reducing malodor; and there is insufficient evidence to give a clear direction for practice with regard to improving quality of life or managing wound symptoms associated with fungating wounds. They stated that more research is needed. Andrew and colleagues (2015) reviewed published RCTs and non RCTs examining the effect of drains and dressings on wound healing rates and complications in posterior spine surgery. The use of post operative drains and the type of post operative dressing is at the discretion of the treating surgeon with no available clinical guidelines. Drains will theoretically decrease incidence of post operative hematoma and therefore, potentially decrease the risk of neurologic compromise when the neural elements have been exposed. Occlusive dressings have more recently been advocated, potentially maintaining a sterile barrier for longer time periods post operatively. A systematic review of databases from 1969 to 2013 was undertaken. All papers examining drains in spine surgery and dressings in primary healing of surgical wounds were included. Revman (version 5.2; The Nordic Cochrane Centre, The Cochrane Collaboration, Oxford, UK) was used to test for overall treatment effect, clinical

23 23 of 38 heterogeneity and risk of bias. Of the papers identified, 1,348 examined post operative drains in spine surgery and 979 wound dressings for primary wound healing of all surgical wounds. A total of 7 studies were included for analysis for post operative drains and 10 studies were analyzed for primary wound healing. The use of a post operative drain did not influence healing rates and had no effect secondarily on infection (odds ratio [OR] 1.33; 95 % CI: 0.76 to 2.30). These researchers were not able to establish whether surgical drains prevent hematomas causing neurologic compromise. There was a slight advantage to using occlusive dressings versus non occlusive dressings in wound healing (OR 2.09; 95 % CI: 1.44 to 3.02). Incisional vacuum dressings as both an occlusive barrier and superficial drainage system have shown promise for wounds at risk of dehiscence. There is a relatively high risk of bias in the methodology of many of the studies reviewed. The authors recommended favoring of occlusive dressings based on heterogeneous and potentially biased evidence. They stated that drain use does not affect wound healing based on similar evidence; and incisional vacuum dressings have shown promise in managing potentially vulnerable wounds. Appendix Staging of Pressure Ulcers: The staging of pressure ulcers is as follows: Stage I Stage II Non blanchable erythema of intact skin Partial thickness skin loss involving epidermis and/or dermis Stage III Full thickness skin loss involving damage or necrosis of subcutaneous tissue that may extend down to, but not through, underlying fascia Stage IV Full thickness skin loss with extensive destruction, tissue necrosis or damage to muscle, bone, or supporting structures

24 24 of 38 CPT Codes / HCPCS Codes / ICD 10 Codes Information in the [brackets] below has been added for clarification purposes. Codes requiring a 7th character are represented by "+": ICD 10 codes will become effective as of October 1, 2015: CPT codes covered if selection criteria are met: Dressings and/or debridement of partial thickness burns, initial or subsequent; small (less than 5% total body surface are) medium (eg, whole face or whole extremity, or 5 % to 10% total body surface area) large (eg, more than one extremity, or greater than 10% total body surface area) Debridement (eg, high pressure waterjet with/without suction, sharp selective debridement with scissors, scalpel and forceps), open wound, (eg, fibrin, devitalized epidermis and/or dermis, exudate, debris, biofilm), including topical application(s), wound assessment, use of a whirlpool, when performed and instruction(s) for ongoing care, per session total wound(s) surface area; first 20 sq cm or less each additional 20 sq cm, or part thereof (list separatley in addition to code for primary procedure) Removal of devitalized tissue from wound(s), nonselective debridement, without anesthesia (eg, wet tomoist dressings, enzymatic, abrasion), including topical application(s), wound assessment, and instruction(s) for ongoing care, per session HCPCS codes covered if selection criteria are met [payment for these supplies may be included in payment for other services rendered]: A4216 Sterile water, saline and/or dextrose, dilute flush, 10 ml [not covered under surgical dressings benefit] A4217 A4450 A4452 Sterile water/saline, 500 ml [not covered under surgical dressings benefit] Tape, non waterproof, per 18 sq. in. Tape, waterproof, per 18 sq. in.

25 25 of 38 A4649 A6025 A6154 A6196 A6199 A6200 A6205 A6206 A6208 A6209 A6215 A6216 A6221 A6222 A6233 A6234 A6241 A6242 A6248 A6250 A6251 A6256 A6257 A6259 A6260 A6261 A6262 A6266 Surgical supply; miscellaneous Gel sheet for dermal or epidermal application, (e.g., silicone, hydrogel, other), each Wound pouch, each Alginate or other fiber gelling dressing Composite dressing Contact layer Foam dressing [not covered for ibuprofen foam dressings for painful venous leg ulcers] Gauze, nonimpregnated, nonsterile Gauze, impregnated Hydrocolloid dressing Hydrogel dressing Skin sealants, protectants, moisturizers, ointments, any type, any size [not covered under surgical dressings benefit] Specialty absorptive dressing Transparent film Wound cleansers, any type, any size [not covered under surgical dressings benefit] Wound filler, gel/paste, per fluid ounce, not otherwise specified Wound filler, dry form, per gram, not otherwise specified Gauze, impregnated, other than water, normal saline, or zinc paste, any width, per linear yard