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1 burns 37 (2011) available at journal homepage: A prospective randomized controlled trial comparing negative pressure dressing and conventional dressing methods on split-thickness skin grafts in burned patients Kiran S. Petkar *, Prema Dhanraj, Paul M. Kingsly, H. Sreekar, Aravind Lakshmanarao, Shashank Lamba, Rahul Shetty, Jewel Raj Zachariah Department of Plastic Surgery, Christian Medical College, Vellore , Tamilnadu, India article info Article history: Accepted 24 May 2011 Keywords: Negative pressure dressings Vacuum assisted closure Skin graft abstract Introduction: Split-thickness skin grafting (SSG) is a technique used extensively in the care of burn patients and is fraught with suboptimal graft take when there is a less-than-ideal graft bed and/or grafting conditions. The technique of Negative Pressure Dressing (NPD), initially used for better wound healing has been tried on skin-grafts and has shown to increase the graft take rates. However, comparative studies between the conventional dressing and vacuum assisted closure on skin grafts in burn patients are unavailable. The present study was undertaken to find out if NPD improves graft take as compared to conventional dressing in burns patients. Materials and methods: Consecutive burn patients undergoing split-skin grafting were randomized to receive either a conventional dressing consisting of Vaseline gauze and cotton pads or to have a NPD of 80 mm Hg for four days over the freshly laid SSG. The results in terms of amount of graft take, duration of dressings for the grafted area and the cost of treatment of wound were compared between the two groups. Results: A total of 40 split-skin grafts were put on 30 patients. The grafted wounds included acute and chronic burns wounds and surgically created raw areas during burn reconstruction. Twenty-one of them received NPD and 19 served as controls. Patient profiles and average size of the grafts were comparable between the two groups. The vacuum closure assembly was well tolerated by all patients. Final graft take at nine days in the study group ranged from 90 to 100 per cent with an average of 96.7 per cent (SD: 3.55). The control group showed a graft take ranging between 70 and 100 percent with an average graft take of 87.5 percent (SD: 8.73). Mean duration of continued dressings on the grafted area was 8 days in cases (SD: 1.48) and 11 days in controls (SD: 2.2) after surgery. Each of these differences was found to be statistically significant ( p < 0.001). Conclusion: Negative pressure dressing improves graft take in burns patients and can particularly be considered when wound bed and grafting conditions seem less-than-ideal. The negative pressure can also be effectively assembled using locally available materials thus significantly reducing the cost of treatment. # 2011 Elsevier Ltd and ISBI. All rights reserved. * Corresponding author. Tel.: address: drkiranpetkar2009@gmail.com (K.S. Petkar) /$36.00 # 2011 Elsevier Ltd and ISBI. All rights reserved. doi: /j.burns

2 926 burns 37 (2011) Introduction Split-thickness skin grafting is a technique used extensively in the care of burn patients during healing of burnt tissues as well as during subsequent reconstructive procedures. Hence, it takes every available knowledge of the phenomenon of graft take and every possible refinement of the technique to ensure best possible results in the unfortunate burn victims whose problems are often compounded by unfavorable local and general conditions as also a short supply of graft donor sites. The present-day conventional techniques of skin grafting are fraught with adversaries of suboptimal graft take due to a lessthan-ideal graft bed, difficulty in apposing the graft to the bed, shearing between the graft and the bed and seroma or hematoma under the graft. The technique of negative pressure dressing (NPD), initially used for better wound healing, has been tried on skin-grafts and has shown to increase the graft take rates [1]. However, comparative studies between the conventional dressing and vacuum assisted closure on skin grafts in burn patients are unavailable. The present study was undertaken to evaluate the difference between the two in clinical terms. 2. Materials and methods The study was conducted at a tertiary hospital with specialized burn unit between July 2009 and June Ethical clearance was obtained from the Institutional Review Board. Consecutive burn patients undergoing split-skin grafting consenting for the study were enrolled. The inclusion criteria were skin grafting in a burnt area, whether acute or old burn. We excluded those with known bleeding tendencies and areas where application of NPD would technically be not possiblee.g. oral commissar, eyelids. The patient characteristics, the nature of wound, its size and the tissue at the floor of the ulcer at the time of skin-grafting were noted. Patients were randomized into study and control groups using an open list of computer-generated random numbers. After the split-skin graft was laid and secured with staplers or catgut sutures as necessary, the control group received a dressing consisting of a Vaseline gauze, cotton pads and cotton bandage (for limbs) or elastic adhesive bandage (for trunk). In the study group, Vaseline gauze was placed on the graft. A low-density polyurethane foam, one and half-inchthick, gas-sterilized with ethylene oxide, was cut to the shape of the graft and placed over the Vaseline gauze. A flexible transparent plastic tube of 5 mm inner diameter and 1 m length was perforated at sides near one end and the same was inserted into the foam by making a shallow slit in the latter. The whole assembly was covered by a broader sterile transparent adhesive film (Opsite) whose edges were sealed to the normal skin surrounding the dressing so that the dressing is isolated from the environment except through the lumen of the plastic tube. The tube was then connected to a continuous wall suction of 80 mm Hg when the patient was shifted from the operation theatre. Effective creation of negative pressure was confirmed by watching for the collapse of the foam and absence of gushing sound of air leak into the system. Splinting and/or elevation of the grafted part was done when deemed necessary in both study and control groups. The dressings were continually observed by the resident nursing staff and suction was assured by visualizing the collapsed foam and absence of gushing sound. All the nursing staff in the plastic surgery ward had had a lecture and a practical demonstration about working of NPD before the start of the study. The grafts were inspected on fourth post-operative day after which, negative pressure dressing if used was discontinued. The patients were followed up for a total of three weeks. Percentage of graft take, as assessed by gross examination by consensus of the treating plastic surgery unit on day 9 was noted. Post-operative day when dressing was discontinued for self-massage with moisturizer was noted. It was a clinical decision of the surgeon taking into account the adherence and stability of the graft. 3. Results A total of forty split skin grafts were put on 30 patients (CONSORT DIAGRAM Fig. 1). Fourteen of them were male and sixteen were female. Twenty-one grafts were covered with negative pressure dressing (NPD) and 19 received conventional dressing. Mean age of the patients in cases was 32 years (range: 7 68 years) and in controls was 28.5 (range: 7 60 years). Indications for skin grafting, site of graft, tissue at the graft bed at the time of grafting and median size of the grafted area were comparable between the two groups (Table 1). A Mann Whitney test showed that there was no significant difference in area of the grafted wounds between the two groups. The cost: The additional cost of the NPD assembly for an average sized ulcer was US$ Polyurethane foam was Table 1 Wound characteristics. Cases (n = 21) Indications for grafting Acute and sub-acute 8 9 post-burn wounds Chronic post-burn 3 2 ulcers (>3 months) Contracture release 7 6 and scar excisions Post-dermabrasion 2 Site Upper limbs 7 5 Trunk 6 5 Lower limbs 8 9 Wound bed Granulation tissue 8 9 Connective tissue 7 6 Fascia 3 2 Scar tissue 3 2 Size Mean size of the wound grafted (square cm) 244 (range: ) Controls (n = 19) 183 (range: )

3 [(Fig._1)TD$FIG] burns 37 (2011) Fig. 1 Consort diagram. obtained from local shops catering to mattress and seatmakers. The low density varieties have pore-size large enough to allow even proteinacious exudates to traverse across into the suction tube. The foam was bought as sheets of 6 feet by 3 feet; cut to required sizes and sterilized. The materials used for NPD (Fig. 2) and their cost per wound of average size: [(Fig._2)TD$FIG] 1. Foam cost (200 cm 2 ): Indian Rupees (INR) Tube (1 m long): INR 8 3. Opsite: INR 430 Total: INR 448 (US$ 9.95) There was no additional charge for the suction as it was part of the bed-nursing charges. The vacuum closure assembly was well tolerated by all patients including children as young as seven years. Patients were not any more inconvenienced than they were with the routine bed rest and immobilization. Air leak was noticed in five dressings which were sealed again by fastening the edge of Fig. 2 Primary outcome showing normal distribution in cases.

4 928 burns 37 (2011) the adhesive film with additional Opsite. The principal investigator personally demonstrated turning off the suction in the event of patient discomfort or blood in the foam/tube to the resident nurse and patient s bystander in each case. No serious adverse effects were noted in either group. Graft take at nine days in the study group ranged from 90 to 100 per cent with an average of 96.7 per cent (SD: 3.55) while the control group showed a graft take ranging between 70 and 100 percent with an average graft take of 87.5 percent (SD: 8.73) (Table 2). Mean duration of dressings on the grafted area was 8 days in cases (SD: 1.48) and 11 days in controls (SD: 2.2) postsurgery (Table 3). Data for both the parameters, followed normal curves (Figs. 2 and 3) and a paired t-test showed that the difference in outcomes were statistically significant with p < One patient in control group underwent re-grafting of the same area for a significant graft loss of 30%. 4. Discussion Negative pressure dressing of wounds first described and popularized by Fleischmann in a series of papers in 1990s [1] has ever since been used in the management of wounds in various clinical settings with mixed results [2,3]. Several [(Fig._3)TD$FIG] Table 2 Percentage graft take. Group N Mean percentage Std. deviation p-value Case <0.001 Control Table 3 Duration of dressings. Group N Mean (in days) Std. deviation p-value Case <0.001 Control animal experiments [4] have recognized that sub-atmospheric pressure increases local blood flow, clears the wound surface of the discharges, reduces bacterial load, decreases edema, increases rate of granulation tissue formation, produces mechanical stress within the tissue resulting in protein and matrix molecular synthesis and enhances epithelialisation. Some of the well known reasons for incomplete graft take are seroma or hematoma under the graft, shearing forces between the graft and the graft bed, improper apposition of the graft on an uneven bed, infection and an inadequately prepared graft bed [5]. The poor general condition of an acute burn patient, scarred tissues at the burn site and a diffuse bleeding at the scars further impede the graft take in burns patients. The vastness of the burn areas and the difficulty in putting a bolster on them or immobilize the part does not help either. Negative pressure dressing on the other hand, apposes the graft firmly onto the bed, sucks out seromas and hematomas, prevents shearing of the graft and aids in immobilizing the part [6]. These effects working in combination with one or more effects mentioned above for the wound help increase the graft take and reduce the duration for complete take of the graft. When used on trunk, the patient is able to change postures to prevent pressure sores without disturbing the graft. Several studies in the past have demonstrated improved quantity and quality of the graft with negative pressure dressing [6 11]. Our study corroborates those findings by demonstrating an increase in the amount of graft take and a faster adherence of the graft to the bed. Besides, our study specifically confirms these effects on acutely or previously burnt tissues. In addition, we have demonstrated that locally available materials can be used for this purpose in place of expensive commercial products, thereby significantly reducing the cost of treatment. However, the assessment could not be blinded in our study owing to the large apparatus needed to apply suction a problem admittedly faced by most of the authors studying VAC or NPD. Being aware that a lack of blinding is capable of producing observer bias, we considered assessment of images [11] or videos by an outside observer, but the clarity was deemed less-than-adequate as compared to visualization by naked eyes. Higher-end 3 0 dimensional imaging equipments with improved quality if available may be used for this purpose in future. We recorded the duration of graft dressing mainly to corroborate the results of final graft take, considering that a better graft take needs shorter duration of dressing. The difference noted in this parameter conceptually made up for the limitation accorded by the lack of blinding to some extent. 5. Conclusion Fig. 3 Primary outcome showing normal distribution in controls. Within the limitations accorded by a lack of blinding, a higher percentage of graft take and reduced duration of graft dressings were noted with the use of negative pressure dressing over split-skin grafts. These corroborative findings suggest: Negative pressure dressing improves graft take and speeds up the process of graft take in burns patients. Hence it should be used particularly when the graft bed and/or grafting conditions seem less-than-ideal for a complete graft take.

5 burns 37 (2011) The negative pressure dressing can also be effectively assembled using locally available materials thus significantly reducing the cost of treatment. Conflicts of interest None. references [1] Fleischmann W, Lang E, Kinzl L. Vacuum assisted wound closure after dermatofasciotomy of the lower extremity. Unfallchirurg 1996;99(April (4)): [2] Ubbink DT, Westerbos SJ, Nelson EA, Vermeulen H. A systematic review of topical negative pressure therapy for acute and chronic wounds. Br J Surg 2008;95(June (6)): [3] Brandi C, Grimaldi L, Nisi G, Silvestri A, Brafa A, Calabrò M, et al. Treatment with vacuum-assisted closure and cryopreserved homologous de-epidermalised dermis of complex traumas to the lower limbs with loss of substance, and bones and tendons exposure. J Plast Reconstr Aesthet Surg 2008;61(December (12)): [Epub 2007 November 13]. [4] Morykwas MJ, Argenta LC, Shelton-Brown EI, McGuirt W. Vacuum-assisted closure: a new method for wound control and treatment: animal studies and basic foundation. Ann Plast Surg 1997;38(June (6)): [5] Thorne CH. Techniques and principles in plastic surgery. In: Thorne CH, Beasley MW, Aston SJ, Bartlett SP, editors. Grabb and Smith s plastic surgery. sixth ed., Lippincott Williams & Wilkins/A Wolters Kluwer Business; p. 8. [6] Blackburn 2nd JH, Boemi L, Hall WW, Jeffords K, Hauck RM, Banducci DR, et al. Negative-pressure dressings as a bolster for skin grafts. Ann Plast Surg 1998;40(May (5)): [7] Andrews BT, Smith RB, Chang KE, Scharpf J, Goldstein DP, Funk GF. Management of the radial forearm free flap donor site with the vacuum-assisted closure (VAC) system. Laryngoscope 2006;116(October (10)): [8] Moisidis E, Heath T, Boorer C, Ho K, Deva AK. A prospective, blinded, randomized, controlled clinical trial of topical negative pressure use in skin grafting. Plast Reconstr Surg 2004;114(September (4)): [9] Schneider AM, Morykwas MJ, Argenta LC. A new and reliable method of securing skin grafts to the difficult recipient bed. Plast Reconstr Surg 1998;102(September (4)): [10] Vidrine DM, Kaler S, Rosenthal EL. A comparison of negative-pressure dressings versus Bolster and splinting of the radial forearm donor site. Otolaryngol Head Neck Surg 2005;133(September (3)): [11] Llanos S, Danilla S, Barraza C, Armijo E, Piñeros JL, Quintas M, et al. Effectiveness of negative pressure closure in the integration of split thickness skin grafts: a randomized, double-masked, controlled trial. Ann Surg 2006;244(November (5)):700 5.

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