Burns 31 (2005) 890–893 www.elsevier.com/locate/burns
Biobrane versus duoderm for the treatment of intermediate thickness burns in children: A prospective, randomized trial Christi Cassidy, Shawn D. St. Peter, Stephanie Lacey, Margie Beery, Paggy Ward-Smith, Ronald J. Sharp, Daniel J. Ostlie * Department of Pediatric Surgery, The Children’s Mercy Hospital, 2401 Gillham Road, Kansas City, MO 64108, USA Accepted 29 April 2005
Abstract In this study, we directly compared the efficacy of Biobrane1 and Duoderm1 for the treatment of small intermediate thickness burns in children in a prospective, randomized fashion to determine their relative impact on wound healing, pain scores, and cost. Patients under 18 years of age with intermediate thickness burns on a surface area less than 10% were enrolled and treated with one of the two dressing systems. Data collected included mechanism of injury, time to complete healing, pain scores, and institutional cost of materials until healing was complete. No significant difference in time to healing or pain scores was detected between the two groups. The cost of each treatment was statistically more expensive in the Biobrane1 group. The results of this study demonstrate that Duoderm1 and Biobrane1 provide equally effective treatment of partial thickness burns among in the pediatric population. However, Duoderm1 is statistically less expensive than Biobrane1 and can be considered a first-line treatment option for intermediate thickness burn wounds in children. # 2005 Elsevier Ltd and ISBI. All rights reserved. Keywords: Biobrane; Duoderm; Prospective; Randomized trial
1. Introduction Burns are the second leading cause of death in children under the age of five and the most common cause of accidental death in the home [1]. While the numbers are declining with the improvement of home prevention awareness programs and better quality control for home heating systems, there are still about 50,000 burn admissions in the United Stated each year among all age groups [2]. Of these injuries, treatment for full-thickness wounds has become more standardized, however, treatment for intermediate thickness injuries is less clear. The aim of treatment for intermediate thickness burns is to promote epithelialization of the wound. While some methods of treatment facilitate outpatient management, children are more likely to require hospital admission to assure adequate dressing changes and wound care. Other important variables besides healing time in the treatment of these burns, particularly in * Corresponding author. Tel.: +1 816 234 3884; fax: +1 816 234 3821. E-mail address:
[email protected] (D.J. Ostlie). 0305-4179/$30.00 # 2005 Elsevier Ltd and ISBI. All rights reserved. doi:10.1016/j.burns.2005.04.029
children, is the comfort of the dressings, comfort of dressing changes, and number of dressing changes [3]. Further, while there are a multitude of treatment options for intermediate thickness wounds, in the current cost-conscious medical market, we should strive to provide the highest quality results within the constraints of the most reasonable costs of treatment. Mean hospital costs for burn admissions are in the range of $40,000 with mean charges approximating $200,000 for the more severe burn injuries [4]. Currently, there are several products that aim to produce a less painful wound dressing which simultaneously provide an occlusive, moist local environment conducive to wound healing. The ultimate goal of these products is to decrease treatment time and discomfort for childhood burn patients. Only standardized comparison of these products will allow medical care providers to make informed decisions about wound management, therefore, in this study, we directly compare Biobrane1 and Duoderm1 for the treatment of small intermediate thickness burns in children. Biobrane1 (Bertek Pharmaceuticals Inc. Morgantown, WV, USA), introduced in 1979, is a biocomposite wound
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dressing consisting of an ultrathin, semipermeable silicone membrane mechanically bonded to a flexible knitted trifilament nylon fabric. It has been shown to be effective in the treatment of superficial, partial-thickness skin burns and donor sites [5–9]. It remains adherent until epithelialization occurs obviating the need for daily debridement and the associated pain. Duoderm1 (ConvaTec Inc., Bristol-Myers Squibb Co., New York City, NY), an occlusive hydrocolloid dressing, has also been shown to be efficacious in the management of donor sites and superficial burns [10–14]. Both products provide an alternative method to the daily care traditionally offered with the advantage of providing an effective barrier which produces an environment conducive to healing with less frequent changes which is clearly advantageous to patients and health care personnel [3,8,9,12–16]. In this study, we directly compared the efficacy of these two dressings in a prospective, randomized fashion to determine their relative impact on wound healing, pain scores, and cost.
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the initial debridement and application of either coverage material. Throughout the remaining dressing changes, pain assessments and pain scores were recorded before and after dressing changes. These were static measurements at the time of dressing changes intended to assess the pain of application. Pain scores were calculated based on the Oucher Score or the Visual Analogue Scale depending on patient age. Both subjective pain scales have been validated and shown to be clinically reliable including children and burn patients [17–21]. 2.4. Statistical analysis All comparisons between patients dressed in Duoderm1 and those in Biobrane1 were performed with an independent sample t-test. Significance was defined as P-value of 0.05.
3. Results 3.1. Demographics
Prior to enrolling patients in the study, approval was obtained from the Institutional Review Board. Patients subsequently enrolled were done so only after obtaining consent from the legal guardian.
A total of 37 patients were randomized into Duoderm1 dressings with the remaining 35 patients in Biobrane1. All enrolled participants completed the study. The study population demographics included 38 males and 34 females. Mechanism of injury included 44 scald burns, 24 contact burns, 2 flame, and 2 miscellaneous injuries.
2.1. Eligibility
3.2. Healing time
Patients were enrolled in the study over a minimum age of 3, and under a maximum age of 18. Depth of injury eligible for the study was defined as a superficial or mid dermal partial thickness burn less than 10% of total body surface area. Burns involving the face, hands, feet, or perineum were not considered for the study. Power analysis prior to enrollment defined 72 participants necessary for 80% power. Therefore, 72 consecutive patients seen by our group with the aforementioned enrollment criteria were analyzed in the study.
No significant difference in time to healing was detected between the two groups. Patients in the Duoderm1 group demonstrated complete re-epithelialization at a mean 11.21 (6.5) days, compared to 12.24 (5.1) days for those dressed in Biobrane1 (P = 0.47).
2. Methods
2.2. Treatment protocol Upon obtaining informed consent, patients were randomized to either wound coverage with Biobrane1 or Duoderm1. Treatment protocols for both groups followed the nursing instruction included in the manufacturer guidelines. No topical or prophylactic antibiotics were utilized. 2.3. Data collection Data collected included mechanism of injury, time to complete healing, pain scores, and institutional cost of materials until healing was complete. Complete healing was defined as complete re-epithelialization as assessed by an experienced burn surgeon or nurse. Pain was assessed after
3.3. Pain scores Pain assessment was performed using the Oucher Scale in 34 participants, with the VAS utilized for the remaining 37 participants. Mean aggregate scores were calculated 2.37 (2.77) in the Duoderm1 group, nearly identical to those scores seen in the Biobrane1 group (2.36 2.62). These scores were not statistically different (P = 0.993). 3.4. Cost The cost of each treatment was statistically more expensive in the Biobrane1 group, regardless of the size or thickness of the dressing (P < 0.001). While the cost of the product in Duoderm1 decreased during data collection for this study, the product remained statistically less expensive (P < 0.001) across time and thus this decrease does not impact the findings of this study. Costs associated with each treatment plan are summarized in Table 1.
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Table 1 Cost comparison between Duoderm1 and Biobrane1
5 5 Biobrane 5 15 Biobrane Thin Duoderm Thick Duoderm P-value
1999 costs (mean S.D., $)
2002 costs (mean S.D., $)
19.79 18.37 39.02 9.93 15.38 11.66 38.58 16.60 <0.001
21.57 19.56 40.62 10.39 5.33 3.94 12.82 5.49 <0.001
in this study combined with the superior clinical efficacy over traditional dressings demonstrated in previous studies, Duoderm1 may be safely considered a first-line treatment option for intermediate thickness burns and donor sites. Further, as the biomedical market continues to harness scientists rapidly expanding knowledge of the molecular events of wound healing to produce more advanced wound care products, it is important that we evaluate these products in direct comparison with the currently most efficacious products like Duoderm1.
4. Discussion While there are abundant data emerging in the literature on the continually evolving wound dressings currently being developed by biomedical companies for the treatment of intermediate thickness wounds, there are few studies comparing their relative merit in a prospective manner. A prospective trial comparing Biobrane1 to traditional dressing changes with 1% silver sulfadiazine demonstrated pain scores, pain medication requirements, wound healing time, and length of hospital stay to be significantly reduced by the use of Biobrane1 [8]. Similarly, prospective evaluations of Duoderm1 compared to 1% silver sulfadiazine have demonstrated that Duoderm1-treated patients had statistically significantly less limitation of activity, better patient compliance, greater patient comfort, better overall acceptance, and felt the treatment was more aesthetically pleasing [12,13]. To date, only one previous prospective study has included both Biobrane1 and Duoderm1 in the study groups [22]. This study compared Biobrane1, Duoderm1, and xeroform dressing on donor sites [22]. In this trial, Duoderm and Biobrane were found to be more comfortable than xeroform dressing, however, the xeroform group had the quickest healing time. Albeit this finding was limited by the study protocol, which did not allow for inspection of wound for healing in both of the biological coverage groups during the covered interval. This study does confirm our findings that Biobrane1 was more expensive than other dressing options. This expense should be considered prohibitive given the fact that neither this study nor the data herein could demonstrate superior results with the more expensive product. Our study does not include a control group with more traditional dressing changes, however, some inferences can be made from the aforementioned studies comparing Biobrane1 or Duoderm1 to silver sulfadiazine. Both of the occlusive dressings studied here have clearly been shown to provide clinically superior results compared to traditional dressings [8,12,13]. Interestingly, due to decreased number of dressing changes and time to complete healing, one study found Duoderm1 to be less expensive than dressing changes with silver sulfadiazine. Our study addresses the important issue of directly comparing next generation wound dressings which found no significant difference in clinical efficacy between Duoderm1 and Biobrane1. However, due to decreased expense of Duoderm1 treatments demonstrated
5. Conclusions The results of this study demonstrate that Duoderm1 and Biobrane1 provide equally effective treatment of second degree burns among in the pediatric population. No significant differences could be demonstrated in healing time or pain control. However, Duoderm1 is statistically less expensive than Biobrane1 and can be considered a first-line treatment option for intermediate thickness burn wounds in children.
Conflict of interest statement All authors of this manuscript hold no financial or personal relationships with other people or organizations that could inappropriately influence their work, all within 3 years of beginning the work submitted.
Acknowledgements We acknowledge and commend the consistently high standard of teamwork and clinical care demonstrated daily by the burn unit and emergency department staff at the Children’s Mercy Hospital.
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