1 Tissue expansion using osmotically active hydrogel systems for direct closure of the donor defect of the radial forearm flap. Plast Reconstr Surg. 2001 Jul; 8(1):1-5, discussion 6-7. Bergé SJ, Wiese KG, von Lindern JJ, Niederhagen B, Appel T, Reich RH. tissue expanders in at forearm with follow up 6 to 18 months tissue expanders Rectangle without silicone shell Direct closure of the donor defect of the radial forearm flap. The study showed that, in nine out of patietns, the expanded skin achieved was sufficient to cover the donor site after raising the forearm flap. Additionally, the expansionrelated swelling pressure was well tolerated by the, the cosmetic results were very satisfactory, and the incidence of complications was very low. By using osmotically active hydrogel tissue expanders, there is no postoperative filling and no risk of complications arising from defective ballon expanders, filling valves, or missing ports. 2 The beginning of a new era: self-filling tissue expander for defect coverage in a 3-year-old boy with a retroauricular nevus. 3 Osmose-Expander ermöglicht Gewebe- Dehnung ohne Nachfüllen 4 O Expansor Autoinflavel-The Self-filling Expander-A New Type of Tissue Expander for Treatment of Burn Scars Plast Reconstr Surg. 2003 Jul; 112(1):189-91. No abstract available. Orthopädie-Technik. 2004 Feb; German Revista Brasileira de Queimaduras. 2004 Maio/ Agosto(2) Vol.4 Ronert MA, Hofheinz H, Olbrisch RR. Ronert MA, Olbrisch RR. Anger J Cases study: 3-year-old boy: Nevus at head Reference to 80 with selfinflating tissue expanders (2/3 breast reconstruction, 1/3 scar treatment) Case report: Female, 15 years scar at left arm with extension to the axillary area Tissue expander Rectangle (with silicone shell) Reference to other cases with 55 expanders in 45 Tissue expander Rectangle 130 ml Defect coverage in a 3- year-old boy with a retroauricular nevus. Osmosis expanders enable tissue expansion without refilling New Type of Tissue Expander for Treatment of Burn Scars In the current case, the device was used to prepare the skin for defect coverage after excision of a large, retroauricular nevus in a 3-year-old boy. After 4 weeks of tissue expansion, the expander created enough skin to easily cover the excised area. The expander is easy and fast to implant without the need for external filling. New skin and tissue expanders e.g. for breast reconstruction after mamma carcinoma surgery or scar treatment after burns facilitate preparatory tissue expansion for and collegues. These osmosis expanders, which are available in different forms and sizes, are implanted through a small incision and grow continously by absorbing body fluid. We may assume that many of the clinical indications for tissue expansion will migrate to the use of this new expander. More clinical experience is also necessary to improve this technique. BK / 2015-12 1/
5 The beginning of a new era in tissue expansion: self-filling osmotic tissue expander--fouryear clinical experience. Plast Reconstr Surg. 2004 Oct; 114(5):25-31. Ronert MA, Hofheinz H, Manassa E, Asgarouladi H, Olbrisch RR. Cases studies for 4- years: 55 75 expanders: Self-filling osmotic tissue expander--fouryear clinical experience. 6 Correction of congenital nasal hypoplasia associated with Kallmann syndrome using selfinflating injectable tissue expander pellets. 7 Cleft palate repair with the use of osmotic expanders: a preliminary report. Plast Reconstr Surg. 2006 Nov; 118(6):1447-52. No abstract available. Plast Reconstr Aesthet Surg. 2007; 60(4):414-21 Mischkowski RA, Kübler AC. Kobus J in different areas of the body: 31 breast reconstructions 4 tumor in face 17 scar revision on extremities 5 naevi treatment Case study: 20-year old male Congenital nasal hypoplasia associated with Kallmann syndrome 19, 2-3 years Clefts 49 tissue expanders also with 1st genration of expanders Round without silicone shell) 26 tissue expander Rectangle (with silicone shell) 8 tissue expander Pin (pellets) Tissue Expander Cylinder without silicone shell Correction of congenital nasal hypoplasia associated with Kallmann syndrome using selfinflating injectable tissue expander pellets. Cleft palate repair with the use of osmotic expanders: a preliminary report. The osmotic tissue expander has many advantages compared with the conventional expander: there is no need for painful external fillings and the risk of external infections is avoided. The expander is percent of its final volume and only requires a short incision and a small pocket. An operation can easily be performed under local anesthesia, with minimal tissue mobilization in older children and compliant. Expander implantation was performed through in a minimalinvasive approach. Expander explantation was carried out previous to cartilage grafting within an open rhinoplasty procedure. The clinical course was uneventful. The aesthetic outcome can be con-sidered as satisfactory, though minor corrections are still necessary. Since the clinical experi-ence with the expander system remains limited yet, the indication for its use has to be care-fully chosen. Concluding, in spite of some shortcomings and unacceptable rate of fistula in wide clefts, the above-presented method seems to be an attractive concept. Despite some technical problems related mostly to still tested optimal filling phase, tissue expansion makes palate repair easier, probably without relaxing incisions and bone denudation. Consequently, some adverse effects on facial growth may be reduced. So far, there is no evidence for it, however, and since this is a preliminary report, there is a need for longer observations and larger material. BK / 2015-12 2/
8 Osmotic tissue expanders in cleft lip and palate surgery: a cautionary tale Journal of Plastic, Reconstructive & Aesthetic Surgery, 2008; 61 : 119 120 Rees L, Morris P, Hall P 1 patient cleft lip and palate surgery Tissue Expander Cylinder without silicone shell Osmotic tissue expanders in cleft lip and palate surgery: a cautionary tale We would advise caution in the use of osmotic expanders in tight and cosmetically sensitive areas such as the face. We acknowledge that we had not completely appreciated the possible rapidity of expansion. Using a silicone envelope to limit initial rapid expansion has been described. We also understand from others that burring down the expander to a smaller pre-expansion size proportional to the ultimate size anticipated makes this a safer product to use. --> see response from Stuart E. James, Martin H. Kelly (No. 9) Self-expanders herald a new era of more precise, targeted tissue expansion, and are especially useful in paediatric facial reconstruction. The final size of the device can readily be controlled by customising its initial proportions and the speed of expansion can be controlled by modifying the composition of polymer. Clinical experience has been positive, with no tissue loss associated with any of these devices. We have used self expanders with uniformly good results in eight rhinoplasty, without ever seeing skin compromise. In summary, when used correctly, the technology is safe and represents a major leap forward in nasal reconstruction. Closure of defects after trauma or excision of neoplasms is a basic skill in plastic surgery. Local, regional and distant flaps lead to additional scars. Skin recruitment by serial excision or skin expansion is a less damaging option for defects that must be closed. Advantages of tissue expansion include good colour and texture match. Disadvantages are the need for a second operation, use of an implant with the attendant risk of infection, time needed for inflation of the device, repeat visits to the clinic, and punctures to inflate the expander. To overcome the last disadvantage, an osmotic expander was developed in Germany in 1999 by OSMED GmbH (Ilmenau). Comment from osmed: Used in contraindication of radiotherapy (3 expanders in 2 ), Expanders had been filled with blood means no hemostasis had been achieved. Migration of expanders: too big pocket, no fixation from outside like recommended 9 Re: 'Osmotic tissue expanders in cleft lip and palate surgery: a cautionary tale' Jounal of Plastic, Reconstructive & Aesthetic Surgery, Volume 62,Issue 1, Jan 2009, Page 112 James SE, Kelly MH. Response to Rees et al. Reference to 8 successful rhinoplasty Re: 'Osmotic tissue expanders in cleft lip and palate surgery: a cautionary tale' --> Response to Ress et. Al The osmotic tissue expander: a three-year clinical experience. J Plast Reconstr Aesthet Surg. 2009 Sep; 62(9):1219-22. doi:.16/j.bjps. 2007.12.088. Epub 2008 Aug 28. Obdeijn MC, Nicolai JP, Werker PM. BK / 2015-12 3/
11 Postburn Scalp Reconstruction Using a Self-filling Osmotic Tissue Expander 12 The osmotic tissue expander: A 5-year experience 13 Osmotic Tissue Expander - Experience in Ten Consecutive Pediatric Cases 14 Reconstruction of a large scalp defect by the sequential use of dermal substitute, selffilling osmotic tissue expander and rotational flap Journal of Burn Care and Research 2009 Volume 30: 744-746 J Plast Reconstr Aesthetic Surg 20 doi:.16/j.bjps. 20.02.002 Plastic & Reconstructive Surgery 20 doi:.97/01.prs. 0000388805.53479.59 Journal of Cutaneous and Aesthetic Surgery May-Aug 20 Volume 3, issue 2, doi:.43/0974-2077.690 23 Zach Sharony, MD, Yaron Rissin, MD, Yehuda Ullmann, MD Chummun S, et al. Gronovich, Yoav et al. Wollina U Bayyoud Y Case study 1 Patient, 18 years who suffered a threedegree burn at age 1 year 5-year-experience (2003-08): (7 childeren, 3 adults) 6 x Scar revision 3 x alopecia 1 x burn contracture (6-15 years ) large congenital nevi (80%) and scars. scalp (20%), shoulder (20%), upper extremities (30%) lower extremities (30%) Case report of 31-yearold male patient Tissue Expander Rectangle 300 ml Postburn Scalp Reconstruction Using a Self-filling Osmotic Tissue Expander 15 tissue expanders The osmotic tissue expander: A 5-year experience 12 tissue expanders Osmotic Tissue Expander - Experience in Ten Consecutive Pediatric Cases Tissue expander Rectangle 300 ml Reconstruction of a large scalp defect by the sequential use of dermal substitute, selffilling osmotic tissue expander and rotational flap Our initial experience with this new, innovative device was excellent. An osmotically active system avoids the disadvantages of traditional silicone balloon expanders, such as pressure peaks following postoperative fillings, infections, and distant valve placement. It minimizes the pain and discomfort during the swelling phase and eases the reconstruction process. We do intent to continue using this device in the future and recommend it to others. Tissue expansion is a valuable technique in soft tissue reconstruction. Osmotic expanders are self-inflating and obviate the need for repeated injections. In doing so, they eliminate port site problems and may reduce the potential to introduce infection. The use of such expanders has become more common in recent years. We report on our experience with the Osmed osmotic expanders over the last 5-years. Osmotic expander is a reliable tool for tissue expansion. The main advantages of this device make it especially suitable for children: Its initial small size allows for insertion through a small surgical incision. There is no need for a drain, and overall operating time is much shorter. The expansion period is more convenient for the patient. The need for external filling injections is eliminated and the risk of infections is lower. Its main disadvantages include the inability to control the filling rate and the necessity to remove it in case of damage to the surrounding tissue. Large scalp defects pose a challenge for the surgeon. Here, we present a 31-year-old male patient with a soft tissue defect on the temple with exposed bone. To allow reconstruction, we placed a self-filling osmotic expander in the subgaleal pocket for 12 weeks. The final volume of the tissue expander was 300 ml. In the last step, a rotational flap was created after removal of the tissue expander from its pocket. Thereby, a tension-free suturing was possible. The post-surgical healing was uncomplicated. Osmotic tissue expanders are a valuable tool for the closure of large tissue defects without the necessity of repeated filling procedures. BK / 2015-12 4/
15 Biomechanical effect of Journal of Biomechanics Wysocki M et al. 65 white rabbits: Tissue Expander Biomechanical effect of There was no observed damage of tissue collagen network in rapid mucoperiosteal (2011), - non-operated control Cylinder without rapid mucoperiosteal both tissue expansion groups analyzed immediately after palatal tissue expansion with the use of osmotic doi:.16/j.jbiomech. 2011.01.012 group - sham-operated silicone shell palatal tissue expansion expansion, and biomechanical profile was not significantly with the use of osmotic different from the profile expanders control group - 24- and 48-hour tissue expansion groups. expanders of control groups. However, rapid tissue expansion activates remodeling of mucoperiosteal tissue structure that revealed significant changes in mechanical properties during the 4-week follow-up. The 24-hour expansion induced transient increase of resilience observed 2 weeks after surgery in comparison to the control groups. As aresult of maturation of newly created collagen fibers and mucoperiosteum rebuilding, there were no significant differences between any of the analyzed tensile parameters 4weeks after the 24-hour expansion. Increased and elongated inflammatory response and connective matrix synthesis observed during healing of 48- hour expanded tissue led to a significant decrease of tensile strength value in comparison to the control groups. Even though 4 weeks after surgery, the resilience of 48-hour expanded tissue was similar to the control groups, tissue healing was not completed and limited scar formation might considerably change the final biomechanical tissue profile. 16 Osmotic expanders in children: No filling no control no problem? Eur J Pediatr Surg Jan 2011 doi:.55/ s-0030-1270460 Böttcher-Haberzeth S et al. 30 children and adolescents with burn scars, congenital nevi, alopecia, or foot deformities 2004-09 53 Tissue Expanders Rectangle Osmotic expanders in children: No filling no control no problem? This is apparently the largest pediatric series in which self-fi lling expanders have been used. The data obtained indicates that self-fi lling expanders can be safely and eff ectively used for various plastic, reconstructive and orthopedic procedures in children and adolescents. The fact that numerous painful and distressing filling sessions are obviated with these expanders is particularly benefi cial for those children too young to understand and cooperate. Moreover, this approach minimizes the risk of infection and lowers costs. BK / 2015-12 5/
Cleft Palate Craniofac J. Jenq TF, Hilliard SM, 2-3 Expander Cylinder per patient 2011 Mar; Kuang AA. 17 Novel use of osmotic tissue expanders to treat difficult anterior palatal fistulas. 18 Selbstexpandierende Hydrogel- Hodenprothesen 48(2):217-21. doi:.1597/09-215. Epub 20 Apr 23. UroForum 05/2011 Sohn M 7 with palatal fistulas were treated with osmotic tissue expanders. 19 : t/o 18 female-to-male transsexuals 26 Tissue Expander Ellipsoid Novel use of osmotic tissue expanders to treat difficult anterior palatal fistulas. Self-expanding hdrogel testicle prosthesis Five had complete closure of the fistula. Two demonstrated slit-like fistulas that were no longer symptomatic and were amenable to closure at time of alveolar bone grafting. No complications were observed. Conclusions: The use of osmotic tissue expanders is a viable alternative for repair of large anterior palatal fistulas, especially in a scarred or previously operated palate. Patients were also no longer symptomatic. The implantation of self-expanding hdrogel testicle prosthesis is a promising procedure of prosthetic proivsion of female-tomale-transsexuals in the course of a operative genital adaption. And at this surgery and for with aplasia or hypoplasia of the scrotum a complex scrotal plastic construction is avoided. It is imaginable to use this technique also after a traumatic, post infectious or iatrogenic loss of scrotum, e.g. Fournier gangrene. Compared to to-be-filled tissue expanders, self-expanding hydrogel testicle prothesis have the advantage that further, with-risk-of-infection related surgeries can be avoided. Furthermore the prothesis can definitely stay in the body. BK / 2015-12 6/
19 The use of Osmed(TM) tissue expanders in paediatric burns reconstruction. Ann Burns Fire Disasters. 2012 Mar 31; 25(1):38-42. Lohana P, Moiemen NS, Wilson YT Patients who were treated with Osmed(TM) expanders for secondary burns reconstruction were recorded. Patient demographics (i.e. burn injury data, indications for surgery), Osmed(TM) tissue expander data (i.e. operative data, complications, problems encountered during and after treatment, explantation time, final expander volume) and overall success were recorded. The use of Osmed(TM) tissue expanders in paediatric burns reconstruction. Results. Twelve Osmed(TM) self-inflating tissue expanders were used in for secondary burns reconstruction between October 2007 and January 2009. All our sustained their burns during childhood. There were three females and one male; the age range was 14-19 yr (mean age, 16 yr). Tissue expanders were removed on average at 6-7 weeks except in two. We noted four complications in our cohort. Overall the mean expansion was 65% of the proposed final volume. Discussion. We found the Osmed(TM) tissue expander simple to implant and well tolerated by our. However, none of the devices achieved full expansion and overexpansion was not possible. We believe conventional tissue expanders are still the gold standard, although osmotic expanders may have a role in burn reconstruction in younger children. Comment from osmed: The expanders did not stay the required period in situ: only 14-64% of recommended swelling time. Consequently the final volume could not be achieved. BK / 2015-12 7/
Int J Burns Trauma Ayşin Karasoy Yeşilada 4 osmed expanders et al. 35 (?) other expanders 20 The feasibility of tissue expansion in reconstruction of congenital and aquired deformities of pediatric 2013; 3(3): 144 150 35 (or 39?) expansion procedures in 25 The feasibility of tissue expansion in reconstruction of congenital and aquired deformities of pediatric Comment from osmed: - statistics inacurate: total of 35 expanders mentioned, but also 35 smooth surface expanders and 4 osmotic expanders (=39) - In 12 years only 25 (how many surgeons were invovled?) - Case1 (forehead): Assumption "ulceration caused by rapid expansion" is very doubtfull. According to author a Rectangle 60 ml was used, but picutre shows round expansion. This indicates that pocket was too small and not according to form of expander. Ucleration is in the centre of expansion, meaning at plane surface. Necrosis (not ulceration) or perforations are usually found at edges of expander. - bad appreciation of osmotic expanders is not understandable. 4 /expanders are statistically not relevant: two cases (hand surgery) seem to have good results, one (forehead) except for ucleration has also a positiv result. The fourth case (cleft palate) is unclear, apparently one expander was used, usually two are used for cleft palate (one for each side). - Author states that 50% of volume is (generally?) gained in first week - which is definitely wrong. Swelling time depends on size of expander. The mentioned Cylinder 2.1ml and Rectangle 60 ml reach 50% volume after approx. respectively 20 days in vitro. In vivo the swelling time is a little longer. That is scientifically provable. The assumption that expander in vivo shall have reached a certain size is subjective, as it is not measurable. - Author supposes that patient felt more discomfort and pain. The contrary is true: There is no pressure peaks at fillings (pain), no incision at filling, and a smaller trauma at insertion as a smaller pocket is needed. - Overexpansion for conventional expanders is praised. That indicates poor planing and/or too short expansion period of expanders. BK / 2015-12 8/
21 Reconstruction with an Osmotic Tissue Expander in Pediatric Patients Plast Reconstr Surg. 2012 May; Gronovich, Yoav et al. cases with pediatric Treated areas: scalp, shoulder, upper and > osmed expanders Reconstruction with an Osmotic Tissue Expander in Pediatric Patients lower extermities 22 Second generation selfinflating tissue expanders: a two-year experience. 23 Novel Use of an Osmotic Self-inflating Tissue Expander for Hypospadias Revision Surgery 129(5):863e-5e. doi:.97/prs. 0b013e31824a9f4e. Plast Surg Int. 2014 2014:457205. doi:.1155/2014/457205. Epub 2014 Jan 23. Urology. 2015 Apr 85(4):924-6. doi:.16/j.urology. 2014.12.040. Al Madani JO Lansdale N, Henderson L, Hennayake S. 17 Treatment of giant nevi or burn scars. A 5-year-old boy Complex pediatric hypospadias repair 55 osmed expanders Second generation selfinflating tissue expanders: a two-year experience. Cylinder 2.1 ml Novel Use of an Osmotic Self-inflating Tissue Expander for Hypospadias Revision Surgery In all cases, the procedures of expander insertion were of short duration and did not exceed 30 minutes. Operative and postoperative management was uneventful. All were discharged on the day of the operation or 1 day after. There were no major complications. Minor complications included partial slough of the skin at the edge of the expanded tissue in one patient, which healed spontaneously. The average expansion period was weeks (range, 5 to 20 weeks). During that time, there were two (range, one to three) follow-up visits. Final aesthetic results were satisfactory in all cases.... Our experience with osmotic tissue expanders showed high satisfaction with in the pediatric population. (1) Second generation tissue expanders look very attractive for burn scar and giant nevi reconstruction. (2) The neck maybe an area for a high extrusion risk, but this needs to be looked at after more cases are done in the neck. Other anatomical areas like age, gender, size of the expander, and indication do not seem to play a role in extrusion. (3) An oversized pocket is advised. (4) The expander can stay for around0dayswithout extrusion, but removal as soonas the expander reaches the required size is advised. (5) If extrusion occurs the expanded skin can still be utilized. (6) Reexpansion seems safe but should be further studied and evaluated. We describe the successful use of an osmotic self-inflating tissue expander for complex pediatric hypospadias repair. A 5- year-old boy, who had undergone previous hypospadias repair and subsequent fistula repair, presented with significant rotation of the penile shaft, with extensive scar tissue but insufficient native penile shaft skin for redo surgery. A 15 6 mm Osmed self-inflating cylindrical expander was used to allow excision of scar tissue and cover with expanded native skin. An excellent cosmetic and functional outcome was achieved at clinic review, 18 months postoperatively. The use of self-inflating tissue expanders offers a novel technique to achieve adequate native skin in the management of complex pediatric hypospadias. BK / 2015-12 9/
24 [Reconstruction in plastic surgery using osmotic tissue expanders] Harefuah. 2015 Mar; Gronovich Y, Binenboym 28, R, Retchkiman M, Eizenman N, Lotan A, Stuchiner B, Tuchman I. 35 osmed expanders Reconstruction in plastic surgery using osmotic tissue expanders 154(3):155-8, 213. Hebrew. Large congenital nevi (75%) and scars (and others) RESULTS: In all of the cases, the operative and post-operative management was uneventful. During the expansion period, there were 2 outpatient clinical visits. The average expansion time was 9 weeks. In 11% (three ) there was partial extrusion of the expander. In all other cases there were no complications and the final aesthetic results were satisfying. DISCUSSION: Osmotic expander is an advanced modality for tissue reconstruction. The final shape and size are precisely predictable. Its initial small size allows for a small surgical incision and short overall operating time. The expansion period is shorter and more convenient for the patient. Its main disadvantage includes the inability to control the filling rate and the need to remove the expander in case of damage to the overlying tissue. CONCLUSION: Osmotic expander is a reliable tool for tissue expansion. It allows for a satisfying aesthetic result in a shorter period of time and with less inconvenience to the patient. Further publications about - Biocompatibility and tissue expansion in general - Ophthalmology - Dental on www.osmed.biz BK / 2015-12 /