Use of topical negative pressure with a lipidocolloid dressing: results of a clinical evaluation

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1 Use of topical negative pressure with a lipidocolloid dressing: results of a clinical evaluation Téot L, Lambert L, Ourabah Z, Bey E, Steenman C, Wierzbiecka E, Malikov S, Charles JP, Vives F, Bohbot S Journal of Wound Care September 2006, 15(8) The enclosed peer-reviewed journal article is provided in the interest of free exchange of truthful scientific information. Restore wound care dressings* are intended for single use in the management of partial- and full-thickness wounds. More than 40% of the treated wounds in this observational study were clinically infected. Restore Contact Layer Dressing may be used on infected wounds only under the care of a healthcare professional. Warnings and Precautions: Do not re-use the dressing. Restore Contact Layer Dressing tends to stick to latex gloves. Moisten latex gloves with normal sterile saline prior to use. Store the dressing flat and at room temperature. Contraindications: Restore Contact Layer Dressing should not be used on individuals who are sensitive to or who have had an allergic reaction to the dressing or one of its components. * The product cited in this article Urgotul (Laboratoires URGO, Dijon, France) is marketed in the U.S. by Hollister Wound Care LLC as Restore Contact Layer Dressing with TRIACT Technology. (In the United States, lipidocolloid technology is known as TRIACT Technology.) The Instructions for Use (IFU) is attached. The full IFU written in English, French and Spanish is available at:

2 Hollister Wound Care LLC has the non-exclusive license to produce, print, publish this article and all parts, adaptations and abridgements thereof in all forms of media, including electronic rights in all languages and territories throughout the universe for a period of one year research Use of topical negative pressure with a lipidocolloid dressing: results of a clinical evaluation l Objective: To evaluate the protection and acceptability of Urgotul wound dressing in the local management of acute or chronic wounds receiving topical negative pressure (TNP) therapy. l Method: This was a prospective multicentre non-comparative open-label trial. At each dressing change the investigating physician clinically evaluated and photographed the wound. Planimetric measurement was undertaken and wound depth was assessed at the start and end of the treatment. Follow-up was undertaken until deemed clinically unnecessary by the investigator. l Results: Sixty-six patients were included (42 acute wounds and 24 chronic wounds) and followed up for an average of 17 days. Dressing changes were deemed entirely painless in 52% of cases (compared with 18% at baseline) and pain between two consecutive dressing changes was absent in 66% of cases (34% at baseline). Removal of the TNP-interface dressing combination was considered very easy or easy in 94% of cases and adherence to the wound was recorded as absent in 88%. On average, the dressings were changed every 3.8 ± 1.1 days (all wounds were considered), and wound area and depth were reduced by 19% and 54% respectively by the end of the follow-up period. l Conclusion: Use of the interface dressing in combination with TNP substantially reduced the pain caused by dressing changes. It therefore makes more acceptable the use of this technique, which aims to optimise the management of wounds that are sometimes considered to be in a therapeutic impasse. l Declaration of interest: This study was sponsored by Laboratoires Urgo, Dijon, France. topical negative pressure therapy; pain; non-adherent interface dressing; clinical evaluation Topical negative pressure is a non-pharmacological technique for the treatment of complex, acute, chronic, infected or noninfected wounds Reported adverse effects include pain 10 mostly when the dressing is removed as buds of granulation tissue become fixed in the foam s open mesh and/or discomfort. 7 Strategies recommended to reduce pain include use of a non-adherent dressing beneath the foam dressing, 10,11 but no clinical evaluation has been conducted to demonstrate its advantages. In France practitioners familiar with topical negative pressure (TNP) often use a lipidocolloid non-adherent dressing (Urgotul, Laboratoires Urgo, Dijon, France) between the foam and wound. 12 Its small mesh size prevents granulation tissue from migrating into the foam, reducing the risk of the buds being damaged. In clinical terms this translates as painless, or almost painless, removal of the foam dressing, and results in improved patient acceptability. 12 Materials and method This multicentre clinical evaluation was conducted in eight French hospitals by departments of plastic and reconstructive surgery, vascular surgery, general surgery and dermatology. The main aim was to assess whether, when used with TNP, Urgotul can be removed without causing trauma to the wound bed, paying particular attention to its ability to reduce pain at dressing removal and its impact on patient acceptability of care procedures. Secondary aims were to evaluate the tolerance (occurrence of local adverse events) and efficacy of this combination. Sixty-six patients whose wounds were being managed with TNP were included. Patients aged under 18, or who were pregnant or lactating were excluded. No other inclusion or exclusion criteria were used. Patients mean age was 57 years (range 16 92). Follow-up, dressing changes and completion of treatment were determined by the investigators, based on their clinical judgement. Wound-area tracings were recorded and photographs taken at the start and end of treatment. Wound depth was measured if subcutaneous tissue was involved. At each dressing removal, the physicians and nurses assessed the wound to determine whether the study goals had been reached. Evaluated treatments Topical negative pressure therapy aids healing by: l Maintaining a warm, moist environment 13 l Draining exudate and reducing bioburden 14,15 l Mobilising interstitial fluid 16 l Improving blood circulation, dermal perfusion L. Téot, MD, Assistant Professor, Plastic and Reconstructive Surgery, University Hospital Montpellier, France; L. Lambert, 1 MD, Head of Department; Z. Ourabah, MD, Assistant, Internal Medecine Department, Charles Foix Hospital, Ivry/Seine, France; E. Bey, 1 MD, Assistant; C. Steenman, MD, Head of General Surgery, Invalides Hospital, Paris, France; E. Wierzbiecka, MD, Assistant, Dermatology Department, University Hospital of Poitiers, France; S. Malikov, MD, Assistant, Vascular and General Surgery Department, La Timone Hospital, Marseille, France; J.P. Charles, MD, Head of Department of Vascular and General Surgery, General Hospital, Aubenas, France; continued overleaf s

3 research F. Vives, 2 MSc, Clinical Study Manager; S. Bohbot, 2 MD, Medical Director; 1 Department of Plastic and Reconstructive Surgery, Percy Hospital Clamart, France; 2 Laboratoires Urgo, Chenôve, France. lteot@aol.com References 1 Banwell, P.E., Téot, L. Topical negative pressure: the evolution of a novel wound therapy. J Wound Care 2003; 12: 1, Meara, J.G., Guo, L., Smith, J.D. et al. Vacuum Assisted Closure in the treatment of degloving injuries. Ann Plast Surg 1999; 42: 6, Banwell, P.E. Topical negative pressure therapy in wound care. J Wound Care 1999; 8: 2, Banwell, P., Withey, S., Holten, I. The use of negative pressure to promote healing. Br J Plast Surg 1998; 511: Joseph, E., Hamori, C., Bergman, S. et al. A prospective randomized trial of Vacuum Assisted Closure versus standard therapy of chronic nonhealing wounds. Wounds 2000; 12: 3, Armstrong, D.A., Lavery, L.A. Negative pressure wound therapy after partial diabetic foot amputation: a multicentre, randomised controlled trial. Lancet 2005; 366: Avery, C., Pereira, J., Moody, A. et al. Clinical experience with the negative pressure wound dressing. Br J Oral Maxillofac Surg 2000; 38: 4, Bauer, P., Schmidt, G., Partecke, B.D. Possibilities of preliminary treatment of infected soft tissue defects by vacuum sealing and PVA foam. Handchir Mikrochir Plast Chir 1998; 30: 1, Philbeck, T.E. Jr, Whittington, K.T., Millsap, M.H. et al. The clinical and cost effectiveness of externally applied negative pressure wound therapy in the treatment of wounds in home healthcare medicare patients. Ostomy Wound Manage 1999; 45: 11, Table 1. Rationales for use of TNP* Table 2. Patients medical histories and vascular distribution 17 l Stimulating neoangiogenesis 5 no. (%) Promote growth of granulation tissue 54 (81.8) Drain exudate 38 (57.5) Pending surgery 28 (42.4) Infected wound 25 (37.8) Therapeutic impasse 4 (6.0)) * More than one response could be selected no. (%) High blood pressure Cardiovascular disease Hyperlipidaemia Diabetes Smoking l Stimulating growth of granulation tissue. 5,18-20 Urgotul is a non-adhesive, non-occlusive dressing composed of 100% polyester textile support impregnated with hydrocolloid particles (carboxymethylcellulose) and Vaseline. As the support is made up of long yarn, no microfibres are released into the wound; its flexibility enables the dressing to fit in close contact with wounds in awkward places. 21,22 Urgotul is effective and well tolerated in the treatment of acute and chronic wounds Its painless removal and excellent acceptability by patients and nurses have been reported in clinical trials. 23,24 Care procedure After cleansing the wound with saline and/or local antiseptic (routine practice in the department), the interface dressing was applied to the wound bed. The TNP foam dressing was cut to match the wound size and positioned on top. The entire assembly was covered with a polyurethane film to make it airtight. A starting negative pressure of 100 or 125mmHg was applied either continuously or intermittently, as considered suitable by the investigator. Statistical analysis A descriptive statistical analysis of all the patients followed up was performed. The tolerance analysis considered all patients who received at least one care procedure with this treatment. Continuous data were described by sample size, mean, standard deviation, median and range. Results As TNP is not widely used in France, investigating physicians (10 in the eight centres) were asked to select a TNP system and indicate their rationale for its use for each patient treated (Table 1). Baseline population and pathology Sixty-six patients were included and followed up. Forty-five patients were male and 21 female; mean age was 57 years (range 16 92). Patients medical histories are given in Table 2. In total, the sample received 1145 days of treatment and underwent 320 documented clinical evaluations and local care procedures. On average, the dressings were removed every 3.8 ± 1.1 days (for all wounds) and the mean treatment duration was 17 days (range 17.4 ± 10.1). Nearly 42 wounds (64%) were acute. Most were postoperative and had been present for an average of 16 days. The remainder (n=24, 36%) were chronic; these were mainly pressure ulcers and had been present for an average of 226 days. Measurements made at the initial visit showed that the treated wounds were on average 111cm 2 in area and 35.8mm deep (calculated on the basis of 54 wounds involving subcutaneous tissue). More than 40% of the treated wounds were clinically infected. In most cases (82%) this prompted administration of oral antibiotics. Other baseline wound characteristics are presented in Table 3. Prior to treatment with the TNP and interface dressing combination, pain was noted in 82% of care procedures, including sharp debridement performed without general anaesthetic. At baseline, pain was also noted between two consecutive dressing changes in 66% of the patients, even though nearly 60% were prescribed oral analgesics (these qualitative data were obtained using an oral questionnaire). The characteristics of this pain at baseline are presented in Table 4. Principal endpoint Pain was evaluated and documented during each care procedure and between two consecutive dressing changes throughout the follow-up period. As this was not a comparative evaluation, it was documented qualitatively. The results (Table 4) formed the basis for the evaluation of whether or not the interface dressing caused trauma on its removal, thereby necessitating pain relief. They were also used to indicate the acceptability of the TNP system to the patient. Removal of the TNP-interface dressing combination was considered to be very easy by patients in 123/319 (39%) cases, easy in 178/319 (56%), difficult in 17/319 (5%) and very difficult in 1/319 (0.3%). The dressing combination adhered to the wound in 39/311 cases (12%); there was no adherence in the remaining 272 cases (88%). There was

4 research no adherence of the interface dressing to the wound in 199/316 cases (63%), minor adherence in 98/316 (31%) and moderate adherence in 19/316 (6%). No bleeding at dressing removal was noted in 169/318 cases (53%), minor bleeding in 121/318 (38%) and moderate bleeding in 28/318 (9%). Maceration was absent in 173/320 dressing removals (54%), minor in 92/320 (29%), moderate in 39/320 (12%) and marked in 16/320 (5%). Malodour was absent in 108/318 dressing removals (34%), minor in 104/318 (33%), moderate in 81/318 (25%) and nauseating in 25/318 (8%). Dressing application was reported as very easy in 49/274 cases (18%), as easy in 200/274 (73%) and difficult in 25/274 (9%). Secondary endpoints l Local tolerance The evaluating physician documented tolerance throughout the follow-up. Three local adverse events were reported, two cases of eczema and one of intolerance, all attributed to the polyurethane membrane, so TNP was discontinued. The condition of the periwound skin was documented at each evaluation. At the end of the followup this was considered as healthy in 45 cases (68%) (compared with n=27, 41% at baseline) and inflamed in 11 cases (17%) (n=27, 32% at baseline). Oedema was reported in one patient (2%) (n=12, 18% at baseline). Maceration was noted in five patients (8%) (n=7, 11% at baseline) and eczema in two cases (3%) (n=6, 9% at baseline). The total is higher than 100% as more than one item could be selected. l Efficacy This was evaluated on the basis of wound size and depth. At the end of the follow-up period the average wound area was 72.1cm² (mean reduction 19%) and the average depth was 22.7mm. (mean reduction 54%). When acute and chronic wounds were considered separately, acute wounds had reduced by 33.5% and 53% in area and depth respectively over a mean treatment period of 15 days, and chronic wounds by 9% and 52% over a mean treatment period of 21.4 days. Time between two dressing removals was 3.8 and 3.7 days for acute and chronic wounds respectively. At the end of the evaluation (after a mean treatment duration of 17 days), 11 wounds (17%) were still considered by the investigating physician to be clinically infected (n=28, 42.4% at baseline); five wounds (46%) were treated with oral antibiotics. Discussion Topical negative pressure therapy has been adopted by many clinicians, and clinical trials have demonstrated its advantages in wounds that were difficult or even impossible to manage with traditional methods Its use may be restricted by often painful dressing removals, 10 but application of a non-adherent dressing under the foam may be a solution. 7 Table 3. Baseline wound characteristics (n=66) Chronic wounds Leg ulcer 5 (7.6%) Pressure ulcer 12 (18.2%) Diabetic foot ulcer 2 (3.0%) Chronic postoperative 5 (7.6%) Total 24 (36.4%) Acute wounds Postoperative 24 (36.4%) Trauma 10 (15.2%) Burn 5 (7.6%) Graft 3 (4.6%) Total 42 (63.6%) Location Leg 15 (22.7%) Foot 12 (18.2%) Thigh 9 (13.6%) Abdomen 5 (7.6%) Forearm 4 (6.1%) Pelvis 2 (3.0%) Back 2 (3.0%) Shoulder 2 (3.0%) Chest 1 (1.5%) Arm 1 (1.5%) Other (sacrum, 13 (19.7%) trochanter, breast, cranium) Surface (cm 2 ) Mean ± SD ± Median (range) 60 (3 550) Depth (mm)* Mean ± SD 36.3 ± 32.1 Median (range) 30 (5 175) * n=54 More than one response was given SD = standard deviation Chronic wound duration (days) Mean ± SD ± Median (range) 90 (8 1080) Acute wound duration (days) Mean ± SD 15.8 ± 20.0 Median (range) 7 (0 76) Type of exposed structure Muscle 37 (23.7%) Adipose tissue 31 (19.9%) Aponeurosis 22 (14.1%) Tendon 18 (11.5%) Periosteum 18 (11.5%) Spongy bone 12 (7.7%) Periosteal bone 5 (3.2%) Prosthetic material 4 (2.6%) Vascular-nervo 1 (0.6%) peduncle Gastrointestinal fistula 1 (0.6%) Other (stump, flap, 7 (4.5%) graft, small intestine) Infected wound Yes 28 (42.4%) No 38 (57.6%) If yes, oral antibiotics 82.1% Condition of periwound skin Healthy 27 (41%) Inflamed 27 (32%) Oedematous 12 (18%) Eczematous 6 (9%) Macerated 7 (11%) Other 6 (9%) s

5 research It was decided not to conduct this clinical evaluation in a comparative manner because of the difficulty in recruiting homogeneous populations and the variety of wounds suitable for TNP. The design therefore is close to a cross-over study; after considering the baseline evaluation of pain experienced without the non-adherent interface dressing, patients were treated with the TNP-interface dressing combination and an indirect comparison was made. This is a study limitation. Despite its non-comparative design, this evaluation for which more than 320 care procedures were documented by nursing staff clearly demonstrated that dressing changes were less painful when the TNP was used with the interface dressing. This is probably because no granulation tissue became attached to the foam dressing as the tight mesh of the interface dressing denied it access. This lack of adherence is similar to that observed with the lipidocolloid dressing in patients with burns and in fragile populations such as children 22 or patients suffering from congenital epidermolysis bullosa skins lesions. 24 These painless or almost painless removals meant care procedures were better accepted and even improved quality of life. The condition of the periwound skin also improved. Such improvements have been reported with the interface dressing when used on leg ulcers, where the skin condition is often altered. 21 For all wounds the average interval between dressing changes was 3.8 days, with no difference between acute or chronic wounds. Dressing changes have been reported to take place every two or three days. 14 Were it to be established that this extended interval is due to the use of the interface dressing beneath the TNP foam, this would doubtless have an economic impact, reducing the overall cost of treatment. As expected, the reduction of the surface area was greater for acute wounds (but no difference in reduction in depth was observed between the two groups); Table 4. Pain during care procedures and between two consecutive dressing changes: at baseline and follow-up During care procedures Baseline Follow-up (%) (%) Absent Minor Moderate Marked Between two consecutive dressing changes Present Absent If present between two consecutive dressing changes, pain intensity Minor Moderate Marked If present between two consecutive dressing changes, pain frequency Occasional Frequent Constant mean treatment time was also shorter for the acute wounds (15 versus 21.5 days for the chronic group). The initial results reported both in the literature and in this evaluation, which was conducted in a larger cohort of patients, indicate TNP should be used with a non-adherent interface dressing to render it more acceptable that is, to substantially reduce pain during dressing changes. n 10 Krasner, D.L. Managing wound pain in patients with vacuum-assisted closure devices. Ostomy Wound Manage 2002; 48: 5, Terrazas, S.G. Adjuvant dressing for negative pressure wound therapy in burns. Ostomy Wound Manage 2006; 52: 1, Lambert, F., Bey, E., Bohbot, S. Intérêt d une interface lipido-colloide (Urgotul) dans le traitement des plaies par pression négative. Conférence des Plaies et Cicatrisations, 2006, Paris. 13 Winter, G.D. Formation of the scab and rate of reepithelialization of superficial wounds in the skin of the young domestic pig. Nature 1962; 193: Morykwas, M.J., Argenta, L.C. Use of negative pressure to decrease bacterial colonization in contamined open wounds. Paper presented at the Annual Meeting of Federation of American Societies for Experimental Biology, Moues, C.M., Vos, M.C., van den Bemd, G.J., et al. Bacterial load in relation to vacuum-assisted closure wound therapy: a prospective randomised trial. Wound Repair Regen 2004; 12: 1, Bucalo, B., Eaglestein, W.H., Falanga, V. Inhibition of cell proliferation by chronic wound fluid. Wound Repair Regen 1993; 1: Dersch, T., Morykwas, M.J., Clark, M., Argenta, L.C. Effects of negative and positive pressure on skin oxygen tension and perfusion. Fourth Annual Meeting of Wound Healing Society, 1994, San Francisco. 18 Morykwas, M.J., Argenta, L.C., Shelton- Brown, E.I. et al. Vacuum Assisted Closure: a new method for wound control and treatment: animal studies and basic foundation. Ann Plast Surg 1997; 38: 6, Morykwas, M.J., Faler, B.J., Pearce, D.J., Argenta, L.C. Effects of varying levels of sub-atmospheric pressure on the rate of granulation tissue formation in experimental wounds in swine. Ann Plast Surg 2001; 45: 5, Fabian, T.S., Kaufman, H.J., Lett, E.D. et al. The evaluation of subatmospheric pressure and hyperbaric oxygen in ischemic full-thickness wound healing. Am Surg 2000; 66: 12, Meaume, S., Senet, P., Dumas, R. et al. Urgotul: a novel non adherent lipidocolloid dressing. Br J Nurs 2002; 11: 16, LeTouze, A., Voinchet, V., Hoecht, B. et al. Using a new lipidocolloid dressing in paediatric wounds: results of French and German clinical studies. J Wound Care 2004; 13: 6, Meaume, S., Téot, L., Lazareth, I. et al. The importance of pain reduction through dressing selection in routine wound management: the MAPP study. J Wound Care 2004; 13: 10, Blanchet-Bardon, C., Bohbot, S. Using Urgotul dressing for the management of epidermolysis bullosa skin lesions. J Wound Care 2005; 14: 10,

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