- Email: [email protected]
Topical silver sulfadiazine vs collagenase ointment for the treatment of partial thickness burns in children: a prospective randomized trial
Journal of Pediatric Surgery (2012) 47, 1204–1207
www.elsevier.com/locate/jpedsurg
Topical silver sulfadiazine vs collagenase ointment for the treatment of partial thickness burns in children: a prospective randomized trial Daniel J. Ostlie ⁎, David Juang, Pablo Aguayo, Janine P. Pettiford-Cunningham, Erin A. Erkmann, Diane E. Rash, Susan W. Sharp, Ronald J. Sharp, Shawn D. St. Peter The Center for Prospective Clinical Trials, The Children's Mercy Hospital, Kansas City, MO 64108, USA Received 27 February 2012; accepted 6 March 2012
Key words: Partial thickness burns; Silver sulfadiazine; Collagenase; Children
Abstract Background: The 2 most commonly used topical agents for partial thickness burns are silver sulfadiazine (SSD) and collagenase ointment (CO). Silver sulfadiazine holds antibacterial properties, and eschar separation occurs naturally. Collagenase ointment is an enzyme that cleaves denatured collagen facilitating separation but has no antibacterial properties. Currently, there are no prospective comparative data in children for these 2 agents. Therefore, we conducted a prospective randomized trial. Methods: After institutional review board approval, patients were randomized to daily debridement with SSD or CO. Primary outcome was the need for skin grafting. Patients were treated for 2 days with SSD with subsequent randomization. Polymyxin was mixed with CO for antibacterial coverage. Debridements were performed daily for 10 days or until the burn healed. Grafting was performed after 10 days if not healed. Results: From January 2008 to January 2011, 100 patients were enrolled, with no differences in patient characteristics. There were no differences in clinical course, outcome, or need for skin grafting. Wound infections occurred in 7 patients treated with CO and 1 patient treated with SSD (P = .06). Collagenase ointment was more expensive than SSD (P b .001). However, total hospital charges did not differ. Conclusion: There are no differences in outcomes between topical SSD or CO in the management of childhood burns results. © 2012 Elsevier Inc. All rights reserved.
During the treatment of partial thickness burns, the burn eschar undergoes mechanical debridement to remove loose and adherent dead tissue until it is determined that the
⁎ Corresponding author. Department of Surgery, Children's Mercy Hospital, Kansas City, MO 64108, USA. Tel.: +1 816 234 3575; fax: +1 816 983 6885. E-mail address: [email protected] (D.J. Ostlie). 0022-3468/$ – see front matter © 2012 Elsevier Inc. All rights reserved. doi:10.1016/j.jpedsurg.2012.03.028
wound will require skin grafting for coverage or that the wound will reepithelialize. The eschar will separate from the burn bed through proteolytic enzymes that are produced in the skin or by colonizing bacteria. Topical agents are used with debridement to facilitate the process. Silver sulfadiazine (SSD) is an antimicrobial agent that sterilizes the wound, which may prevent infection, but then depends on the natural proteolytic enzymes in the skin to promote separation during the mechanical debridement treatment
Topical silver sulfadiazine vs collagenase ointment regimen. Silver sulfadiazine was initially introduced in the 1960s and has been a mainstay of treatment for the care of burns since [1]. Collagen is a protein that is highly present in skin (~75% of dry weight of skin) and is the dominant protein that must be divided to allow for eschar separation. Collagenase is an exogenous enzyme that breaks down denatured collagen but does not breakdown healthy, normal collagen. Collagenase Santyl ointment (CO) (Healthpoint Biotherapeutics, Fort Worth, TX) is used in many burn units for the treatment of partial thickness burns. Despite the widespread use of both SSD and CO, there has not been a prospective randomized comparison of these 2 agents in children. Therefore, we performed a prospective randomized trial comparing SSD and CO for the treatment of partial thickness in children to determine if one was superior to the other with regard to the need for subsequent skin grafting.
1. Methods Approval was obtained from our institutional review board (institutional review board no. 07 11-174) before enrolling patients in this study. Patients were enrolled only after obtaining parental permission. The consent forms and consent process were evaluated by the institutional review board on a continual basis.
1.1. Participants The study population consisted of patients admitted to our institution with partial thickness burns less than 48 hours from thermal injury. Inclusion criteria included patients from 2 months to 18 years of age admitted to our burn unit with partial thickness burns. Patients were excluded for sulfa allergy or a burn greater than 25% total body surface area (TBSA).
1.2. Interventions After the initial debridement on admission, all patients were dressed with SSD, which was used for the first 2 days of daily debridement. After 2 days, patients were then randomized to continue daily debridement with either SSD or CO for up to10 days. Polymyxin was added to the CO because it has no antibacterial properties.
1.3. Sample size The primary outcome variable was the failure to heal the burn with the need for skin grafting. Using a power of 0.80 and α of .05, and retrospective graft rates for both SSD cream and CO from our own institution, a sample size of 67 patients
1205 in each arm was established. Assuming a 10% attrition rate, the sample size was set at 75 patients in each arm.
1.4. Assignment A computer-generated individual unit of randomization was used in a nonstratified sequence in blocks of 10. The randomization sequence was not available to the caregivers performing the daily debridement, and the randomization sequence was assessed after consent for study enrollment to identify the next allotment. Parents who were suspected of child abuse on admission were not offered enrollment.
1.5. Protocol Management protocol was fixed using computer order sets for all patients with predetermined parameters for resuscitation, pain management, nutrition, and debridement technique. All patients were seen daily by physical and/or occupational therapy to ensure adequate range-of-motion exercises were performed. If the burns involved a joint, splints were made to prevent contracture of the burn bed. Debridements were carried out by specially trained burn unit nurses only and including mechanical debridement of all loose eschar followed by ultrasonic whirlpool baths and reapplication of the specified topical agent and sterile dressings. Nutritional status was evaluated daily, including daily weight and caloric content to ensure adequate enteral intake. Nasogastric feeding tubes were placed to provide tube feeds in patients who were unable to orally sustain the required caloric intake. Electrolytes and a complete blood count were assessed at admission and biweekly. All patients were treated for 10 days using the assigned treatment regimen, unless the burn was healed or signs of burn eschar infection developed. Infections were treated with either SSD cream or 5% Sulfamyalon-soaked burn dressings (Sulfamyalon, UDL Laboratories, Inc, Rockford, IL), but tissue biopsy was not performed. If the patients' burns healed during the treatment time frame, the daily wound debridement was discontinued. The parents were educated on the care of the healed burn beds, which were treated with Eucerin cream, and the patients were discharged with planned follow-up in the outpatient burn clinic in 1 week. Patients who completed 10 days of the assigned treatment regimen and did not achieve burn healing were treated with skin grafting. All patients received cefazolin (25 mg/kg) preoperatively. The burn surgeon determined the type of skin graft performed at the time of grafting. Postgrafting dressing and wound care were identical between groups. Skin grafts involving the lower leg and/or forearm were placed in fiberglass casts. Discharge after grafting was dependent on the location and extent of grafting required. Activity and range-of-motion therapy was initiated 14 days postgrafting, and physical/occupational therapy was continued in all patients until adequate range of motion was achieved.
1206
D.J. Ostlie et al.
1.6. Data collection
Table 2
Patient demographics, burn size in % TBSA burned, and burn degree were recorded. Operative data including % TBSA grafted, hospital, and outpatient courses and clinical variables were recorded. Evaluation of the data was planned after enrollment of 50 patients and 100 patients to assure safety between treatment arms.
1.7. Statistical analysis All data were analyzed on an intent-to-treat basis. Data are expressed as mean ± SD. Continuous variables were compared using an independent sample, 2-tailed Student t test. Discrete variables were analyzed using the Fisher exact test. Significance was defined as P ≤ .05.
2. Results From January 2008 to January 2011, 100 patients were enrolled with 50 in each arm. The data were reviewed at 100 patients, which revealed no attrition and no difference in the primary outcome variable, so enrollment was discontinued.
2.1. Demographics There was no difference in sex, age, weight, or % TBSA burned between the 2 groups (Table 1).
Outcome data
Need for skin graft % TBSA grafted Total no. of treatments Time to skin grafting (d) Length of stay (d) Length of follow-up (mo) Burn wound infection
SSD (n = 50)
Collagenase (n = 50)
P
36% 5.4 ± 4.2 11.0 ± 3.8 13.5 ± 4.6 11.2 ± 5.2 5.8 ± 7.5 1
32% 5.1 ± 4.0 11.0 ± 4.1 12.9 ±2.0 11.3 ± 5.8 8.0 ± 8.9 7
.68 .86 .92 .68 .91 .17 .06
There were 26 patients treated with SSD and 29 patients treated with CO who lost weight during their hospitalization. Although both groups lost weight while undergoing treatment, there was no statistical difference in the % body weight lost between groups, with the SSD group losing 6.4% ± 5.5% and the CO group losing 7.3% ± 5.4% (P = .40). Assumed burn bed infections occurred in 7 patients treated with CO and 1 patient treated with SSD. A single patient treated with CO underwent treatment for a herpes infection. There were no cases of systemic bacteremia in either group, and there was no difference in systemic antibiotic or antiviral charges (SSD: $73 vs CO: $177, P = 0.30). Financial differences were only seen in the medication charges. Combined charges for CO/polymyxin were $1082 compared with $444 for SSD (P b .001). However, overall hospital charges, charges per day, and charges per day per burn size did not differ between groups (Table 3).
2.2. Skin grafting data The primary outcome variable, the need for skin grafting, did not differ between the 2 groups, with one-third of patients requiring grafting (Table 2). The time to skin grafting after the initial burn also did not differ between the 2 groups, nor did the length of follow-up.
2.3. Hospital course The parameters describing the hospital course are outlined in Table 2. There were no differences in the time required to complete the daily treatment, number of treatments, narcotic requirements, or length of hospitalization.
Table 1
3. Discussion The initial treatment of partial thickness burns is debridement and coverage with a topical agent that provides antibacterial coverage and allows for burn eschar separation [2-5]. The long-term sequelae of burns in children can be immense with lifelong implications. Therefore, it is important to understand the treatment options and expected outcomes of those options to prevent the complications associated with the treatment of childhood burns. There are a host of wound coverage alternatives available. Enzymatic ointment with an antibiotic additive aiding in eschar separation and SSD cream are 2 of the most commonly used topical agents for partial thickness burns
Patient demographics
Sex (M:F) Mean age (y) Weight (kg) Height % TBSA burn (% male)
SSD (n = 50)
Collagenase (n = 50)
P
35:15 5.1 ± 4.5 22.3 ± 16.7 11.2 ± 5.2 9.4 ± 6.1
29:21 4.8 ± 4.5 20.8 ± 15.1 11.3 ± 5.8 9.9 ± 6.8
.21 .70 .61 .91 .64
Table 3
Financial data (thousands of dollars)
Hospital charges Charges/d Charges/d per burn size
SSD (n = 50)
Collagenase (n = 50)
P
71.3 ± 44.1 6.1 ± 1.9 1.1 ± 1.0
78.9 ± 51.7 6.7 ± 1.0 1.1 ± 1.3
.43 .13 .91
Topical silver sulfadiazine vs collagenase ointment [3,4,6-9]. Collagenase ointment is widely used as the enzymatic debridement agent of choice, and it has been suggested that its use will shorten the duration of time to wound healing. Primary criticisms of CO are its associated expense compared with SSD and the suggested increased infectious risk when used alone. Supporters report that it leads to shorter duration to wound healing, saving total resources, and no increased risk of infection when combined with an antibiotic ointment or powder [3,4,7,8]. Although SSD cream has been a mainstay of burn care since 1967 [1] and has excellent antibacterial properties, it has been suggested that it does not result in as fast wound healing as other agents. Some authors have suggested that SSD is a more painful treatment than other enzymatic or topical dressings [10]. In this study, we showed that under a controlled treatment pathway for each agent, including the number of treatment days, daily treatment duration, number of treatments performed, and timing of operative intervention, there was no difference in the need for skin grafting between SSD and CO. It has been shown in animals and may be argued for humans that ignoring the need for skin grafting and continuing to treat patients until the burn bed is healed would reveal that the combination of mechanical and enzymatic debridement results in a more rapid wound bed healing process than SSD and mechanical debridement [3,4,7]. We feel that 12 days is physiologically sufficient for healing, and ongoing topical treatments would lead to further patient and family discomfort without identifiable benefit. This assumption is supported by the fact that the average % TBSA for all patients was 9.7%, and after an average of 13 days, patients who required a skin graft continued to have 5.3 % TBSA that needs to be grafted. Although there is no way to accurately predict how much longer it would take to heal the remaining 5.3%, it appears that there is no treatment superiority. In addition, it has been shown that the risk for the development of hypertrophic scar development is related to wound healing time [11]. The 2 major criticisms of CO are infection risk and expense. Our data revealed that, although not statistically significant, there was more suspected infections in the CO group (n = 7) compared with the SSD group (n = 1). We did not perform tissue biopsies to quantify bacterial counts, but rather used clinical signs and symptoms including fever, dressing discoloration, and wound bed odor and appearance. It could be argued that with more patients, we would have found a statistically significant difference in the infection rates. However, all suspected infections in this study were treated without clinical sequela including length of stay, delay in skin grafting, or antibiotic charges. In addition, there were no cases of systemic bacteremia, so although the risk
1207 for suspected infections may be higher in the CO group, those suspected infections are of little clinical relevance. Because CO/polymyxin is more expensive than SSD, it is expected that the overall charges for SSD would be significantly less when compared with CO. However, that difference was only $842, which is a small amount within the overall hospital charges and, therefore, does not affect the statistical evaluation of total charges. Further evaluation of the expense data looking at charges per day and charges per day per burn size also did not show any difference between the 2 groups. These data support the finding that the more significant charges of hospital room, treatment room times, and operative interventions far outweigh the minimal difference in topical agent expense, and therefore, agent choice should not be determined by agent cost. Therefore, this study has shown that the use of SSD cream and CO/polymyxin in the treatment of partial thickness burns in children results in equivalent outcomes including skin graft rates, length of stay, and hospital charges.
References [1] Fox Jr CL. Silver sulfadiazine—a new topical therapy for Pseudomonas in burns. Therapy of Pseudomonas infection in burns. Arch Surg 1968;96:184-8. [2] Kumar RJ, Kimble RM, Boots R, et al. Treatment of partial-thickness burns: a prospective randomized trial using TransCyte. ANZ J Surg 2004;74:622-6. [3] Costagliola M, Agrosi M. Second-degree burns: a comparative, multicenter, randomized trial of hyaluronic acid plus silver sulfadiazine vs silver sulfadiazine alone. Curr Med Res Opin 2005;21:1235-40. [4] Soroff HS, Sasvary D. Collagenase ointment and polymyxin B sulfate/ bacitracin spray versus silver sulfadiazine cream in partial thickness burns: a pilot study. J Burn Care Rehabil 1994;15:13-7. [5] Chung DH, Herndon DN. Burns. In: Holcomb III GW, Murphy JP, editors. Ashcraft's pediatric surgery. 5th Edition. Philadelphia (Pa): Saunders Elsevier; 2010. p. 154-66. [6] Wasiak J, Cleland H, Campbell F. Dressings for superficial and partial thickness burns. Cochrane Database Syst Rev 2008;4:CD002106. [7] Hansbrough JF, Achauer B, Dawson J, et al. Wound healing in partialthickness burn wounds treated with collagenase ointment versus silver sulfadiazine cream. J Burn Care Rehabil 1995;16:241-7. [8] Ozcan C, Erqun O, Celik A, et al. Enzymatic debridement of burn wounds with collagenase in children with partial thickness burns. Burns 2002;28:791-4. [9] Atiyeh BS, Costagliola M, Hayek SN, et al. Effect of silver on burn wound infection control and healing: review of the literature. Burns 2007;33:139-48. [10] Glat PM, Kubat WD, Hsu JF, et al. Randomized clinical study of SilvaSorb gel in comparison to Silvadene silver suilfadiazine cream in the management of partial-thickness burns. J Burn Care Res 2009;30: 262-7. [11] Cubison TC, Pape SA, Parkhouse N. Evidence for the link between healing time and the development of hypertrophic scars (HTS) in paediatric burns due to scald injury. Burns 2006;32:992-9.
www.elsevier.com/locate/jpedsurg
Topical silver sulfadiazine vs collagenase ointment for the treatment of partial thickness burns in children: a prospective randomized trial Daniel J. Ostlie ⁎, David Juang, Pablo Aguayo, Janine P. Pettiford-Cunningham, Erin A. Erkmann, Diane E. Rash, Susan W. Sharp, Ronald J. Sharp, Shawn D. St. Peter The Center for Prospective Clinical Trials, The Children's Mercy Hospital, Kansas City, MO 64108, USA Received 27 February 2012; accepted 6 March 2012
Key words: Partial thickness burns; Silver sulfadiazine; Collagenase; Children
Abstract Background: The 2 most commonly used topical agents for partial thickness burns are silver sulfadiazine (SSD) and collagenase ointment (CO). Silver sulfadiazine holds antibacterial properties, and eschar separation occurs naturally. Collagenase ointment is an enzyme that cleaves denatured collagen facilitating separation but has no antibacterial properties. Currently, there are no prospective comparative data in children for these 2 agents. Therefore, we conducted a prospective randomized trial. Methods: After institutional review board approval, patients were randomized to daily debridement with SSD or CO. Primary outcome was the need for skin grafting. Patients were treated for 2 days with SSD with subsequent randomization. Polymyxin was mixed with CO for antibacterial coverage. Debridements were performed daily for 10 days or until the burn healed. Grafting was performed after 10 days if not healed. Results: From January 2008 to January 2011, 100 patients were enrolled, with no differences in patient characteristics. There were no differences in clinical course, outcome, or need for skin grafting. Wound infections occurred in 7 patients treated with CO and 1 patient treated with SSD (P = .06). Collagenase ointment was more expensive than SSD (P b .001). However, total hospital charges did not differ. Conclusion: There are no differences in outcomes between topical SSD or CO in the management of childhood burns results. © 2012 Elsevier Inc. All rights reserved.
During the treatment of partial thickness burns, the burn eschar undergoes mechanical debridement to remove loose and adherent dead tissue until it is determined that the
⁎ Corresponding author. Department of Surgery, Children's Mercy Hospital, Kansas City, MO 64108, USA. Tel.: +1 816 234 3575; fax: +1 816 983 6885. E-mail address: [email protected] (D.J. Ostlie). 0022-3468/$ – see front matter © 2012 Elsevier Inc. All rights reserved. doi:10.1016/j.jpedsurg.2012.03.028
wound will require skin grafting for coverage or that the wound will reepithelialize. The eschar will separate from the burn bed through proteolytic enzymes that are produced in the skin or by colonizing bacteria. Topical agents are used with debridement to facilitate the process. Silver sulfadiazine (SSD) is an antimicrobial agent that sterilizes the wound, which may prevent infection, but then depends on the natural proteolytic enzymes in the skin to promote separation during the mechanical debridement treatment
Topical silver sulfadiazine vs collagenase ointment regimen. Silver sulfadiazine was initially introduced in the 1960s and has been a mainstay of treatment for the care of burns since [1]. Collagen is a protein that is highly present in skin (~75% of dry weight of skin) and is the dominant protein that must be divided to allow for eschar separation. Collagenase is an exogenous enzyme that breaks down denatured collagen but does not breakdown healthy, normal collagen. Collagenase Santyl ointment (CO) (Healthpoint Biotherapeutics, Fort Worth, TX) is used in many burn units for the treatment of partial thickness burns. Despite the widespread use of both SSD and CO, there has not been a prospective randomized comparison of these 2 agents in children. Therefore, we performed a prospective randomized trial comparing SSD and CO for the treatment of partial thickness in children to determine if one was superior to the other with regard to the need for subsequent skin grafting.
1. Methods Approval was obtained from our institutional review board (institutional review board no. 07 11-174) before enrolling patients in this study. Patients were enrolled only after obtaining parental permission. The consent forms and consent process were evaluated by the institutional review board on a continual basis.
1.1. Participants The study population consisted of patients admitted to our institution with partial thickness burns less than 48 hours from thermal injury. Inclusion criteria included patients from 2 months to 18 years of age admitted to our burn unit with partial thickness burns. Patients were excluded for sulfa allergy or a burn greater than 25% total body surface area (TBSA).
1.2. Interventions After the initial debridement on admission, all patients were dressed with SSD, which was used for the first 2 days of daily debridement. After 2 days, patients were then randomized to continue daily debridement with either SSD or CO for up to10 days. Polymyxin was added to the CO because it has no antibacterial properties.
1.3. Sample size The primary outcome variable was the failure to heal the burn with the need for skin grafting. Using a power of 0.80 and α of .05, and retrospective graft rates for both SSD cream and CO from our own institution, a sample size of 67 patients
1205 in each arm was established. Assuming a 10% attrition rate, the sample size was set at 75 patients in each arm.
1.4. Assignment A computer-generated individual unit of randomization was used in a nonstratified sequence in blocks of 10. The randomization sequence was not available to the caregivers performing the daily debridement, and the randomization sequence was assessed after consent for study enrollment to identify the next allotment. Parents who were suspected of child abuse on admission were not offered enrollment.
1.5. Protocol Management protocol was fixed using computer order sets for all patients with predetermined parameters for resuscitation, pain management, nutrition, and debridement technique. All patients were seen daily by physical and/or occupational therapy to ensure adequate range-of-motion exercises were performed. If the burns involved a joint, splints were made to prevent contracture of the burn bed. Debridements were carried out by specially trained burn unit nurses only and including mechanical debridement of all loose eschar followed by ultrasonic whirlpool baths and reapplication of the specified topical agent and sterile dressings. Nutritional status was evaluated daily, including daily weight and caloric content to ensure adequate enteral intake. Nasogastric feeding tubes were placed to provide tube feeds in patients who were unable to orally sustain the required caloric intake. Electrolytes and a complete blood count were assessed at admission and biweekly. All patients were treated for 10 days using the assigned treatment regimen, unless the burn was healed or signs of burn eschar infection developed. Infections were treated with either SSD cream or 5% Sulfamyalon-soaked burn dressings (Sulfamyalon, UDL Laboratories, Inc, Rockford, IL), but tissue biopsy was not performed. If the patients' burns healed during the treatment time frame, the daily wound debridement was discontinued. The parents were educated on the care of the healed burn beds, which were treated with Eucerin cream, and the patients were discharged with planned follow-up in the outpatient burn clinic in 1 week. Patients who completed 10 days of the assigned treatment regimen and did not achieve burn healing were treated with skin grafting. All patients received cefazolin (25 mg/kg) preoperatively. The burn surgeon determined the type of skin graft performed at the time of grafting. Postgrafting dressing and wound care were identical between groups. Skin grafts involving the lower leg and/or forearm were placed in fiberglass casts. Discharge after grafting was dependent on the location and extent of grafting required. Activity and range-of-motion therapy was initiated 14 days postgrafting, and physical/occupational therapy was continued in all patients until adequate range of motion was achieved.
1206
D.J. Ostlie et al.
1.6. Data collection
Table 2
Patient demographics, burn size in % TBSA burned, and burn degree were recorded. Operative data including % TBSA grafted, hospital, and outpatient courses and clinical variables were recorded. Evaluation of the data was planned after enrollment of 50 patients and 100 patients to assure safety between treatment arms.
1.7. Statistical analysis All data were analyzed on an intent-to-treat basis. Data are expressed as mean ± SD. Continuous variables were compared using an independent sample, 2-tailed Student t test. Discrete variables were analyzed using the Fisher exact test. Significance was defined as P ≤ .05.
2. Results From January 2008 to January 2011, 100 patients were enrolled with 50 in each arm. The data were reviewed at 100 patients, which revealed no attrition and no difference in the primary outcome variable, so enrollment was discontinued.
2.1. Demographics There was no difference in sex, age, weight, or % TBSA burned between the 2 groups (Table 1).
Outcome data
Need for skin graft % TBSA grafted Total no. of treatments Time to skin grafting (d) Length of stay (d) Length of follow-up (mo) Burn wound infection
SSD (n = 50)
Collagenase (n = 50)
P
36% 5.4 ± 4.2 11.0 ± 3.8 13.5 ± 4.6 11.2 ± 5.2 5.8 ± 7.5 1
32% 5.1 ± 4.0 11.0 ± 4.1 12.9 ±2.0 11.3 ± 5.8 8.0 ± 8.9 7
.68 .86 .92 .68 .91 .17 .06
There were 26 patients treated with SSD and 29 patients treated with CO who lost weight during their hospitalization. Although both groups lost weight while undergoing treatment, there was no statistical difference in the % body weight lost between groups, with the SSD group losing 6.4% ± 5.5% and the CO group losing 7.3% ± 5.4% (P = .40). Assumed burn bed infections occurred in 7 patients treated with CO and 1 patient treated with SSD. A single patient treated with CO underwent treatment for a herpes infection. There were no cases of systemic bacteremia in either group, and there was no difference in systemic antibiotic or antiviral charges (SSD: $73 vs CO: $177, P = 0.30). Financial differences were only seen in the medication charges. Combined charges for CO/polymyxin were $1082 compared with $444 for SSD (P b .001). However, overall hospital charges, charges per day, and charges per day per burn size did not differ between groups (Table 3).
2.2. Skin grafting data The primary outcome variable, the need for skin grafting, did not differ between the 2 groups, with one-third of patients requiring grafting (Table 2). The time to skin grafting after the initial burn also did not differ between the 2 groups, nor did the length of follow-up.
2.3. Hospital course The parameters describing the hospital course are outlined in Table 2. There were no differences in the time required to complete the daily treatment, number of treatments, narcotic requirements, or length of hospitalization.
Table 1
3. Discussion The initial treatment of partial thickness burns is debridement and coverage with a topical agent that provides antibacterial coverage and allows for burn eschar separation [2-5]. The long-term sequelae of burns in children can be immense with lifelong implications. Therefore, it is important to understand the treatment options and expected outcomes of those options to prevent the complications associated with the treatment of childhood burns. There are a host of wound coverage alternatives available. Enzymatic ointment with an antibiotic additive aiding in eschar separation and SSD cream are 2 of the most commonly used topical agents for partial thickness burns
Patient demographics
Sex (M:F) Mean age (y) Weight (kg) Height % TBSA burn (% male)
SSD (n = 50)
Collagenase (n = 50)
P
35:15 5.1 ± 4.5 22.3 ± 16.7 11.2 ± 5.2 9.4 ± 6.1
29:21 4.8 ± 4.5 20.8 ± 15.1 11.3 ± 5.8 9.9 ± 6.8
.21 .70 .61 .91 .64
Table 3
Financial data (thousands of dollars)
Hospital charges Charges/d Charges/d per burn size
SSD (n = 50)
Collagenase (n = 50)
P
71.3 ± 44.1 6.1 ± 1.9 1.1 ± 1.0
78.9 ± 51.7 6.7 ± 1.0 1.1 ± 1.3
.43 .13 .91
Topical silver sulfadiazine vs collagenase ointment [3,4,6-9]. Collagenase ointment is widely used as the enzymatic debridement agent of choice, and it has been suggested that its use will shorten the duration of time to wound healing. Primary criticisms of CO are its associated expense compared with SSD and the suggested increased infectious risk when used alone. Supporters report that it leads to shorter duration to wound healing, saving total resources, and no increased risk of infection when combined with an antibiotic ointment or powder [3,4,7,8]. Although SSD cream has been a mainstay of burn care since 1967 [1] and has excellent antibacterial properties, it has been suggested that it does not result in as fast wound healing as other agents. Some authors have suggested that SSD is a more painful treatment than other enzymatic or topical dressings [10]. In this study, we showed that under a controlled treatment pathway for each agent, including the number of treatment days, daily treatment duration, number of treatments performed, and timing of operative intervention, there was no difference in the need for skin grafting between SSD and CO. It has been shown in animals and may be argued for humans that ignoring the need for skin grafting and continuing to treat patients until the burn bed is healed would reveal that the combination of mechanical and enzymatic debridement results in a more rapid wound bed healing process than SSD and mechanical debridement [3,4,7]. We feel that 12 days is physiologically sufficient for healing, and ongoing topical treatments would lead to further patient and family discomfort without identifiable benefit. This assumption is supported by the fact that the average % TBSA for all patients was 9.7%, and after an average of 13 days, patients who required a skin graft continued to have 5.3 % TBSA that needs to be grafted. Although there is no way to accurately predict how much longer it would take to heal the remaining 5.3%, it appears that there is no treatment superiority. In addition, it has been shown that the risk for the development of hypertrophic scar development is related to wound healing time [11]. The 2 major criticisms of CO are infection risk and expense. Our data revealed that, although not statistically significant, there was more suspected infections in the CO group (n = 7) compared with the SSD group (n = 1). We did not perform tissue biopsies to quantify bacterial counts, but rather used clinical signs and symptoms including fever, dressing discoloration, and wound bed odor and appearance. It could be argued that with more patients, we would have found a statistically significant difference in the infection rates. However, all suspected infections in this study were treated without clinical sequela including length of stay, delay in skin grafting, or antibiotic charges. In addition, there were no cases of systemic bacteremia, so although the risk
1207 for suspected infections may be higher in the CO group, those suspected infections are of little clinical relevance. Because CO/polymyxin is more expensive than SSD, it is expected that the overall charges for SSD would be significantly less when compared with CO. However, that difference was only $842, which is a small amount within the overall hospital charges and, therefore, does not affect the statistical evaluation of total charges. Further evaluation of the expense data looking at charges per day and charges per day per burn size also did not show any difference between the 2 groups. These data support the finding that the more significant charges of hospital room, treatment room times, and operative interventions far outweigh the minimal difference in topical agent expense, and therefore, agent choice should not be determined by agent cost. Therefore, this study has shown that the use of SSD cream and CO/polymyxin in the treatment of partial thickness burns in children results in equivalent outcomes including skin graft rates, length of stay, and hospital charges.
References [1] Fox Jr CL. Silver sulfadiazine—a new topical therapy for Pseudomonas in burns. Therapy of Pseudomonas infection in burns. Arch Surg 1968;96:184-8. [2] Kumar RJ, Kimble RM, Boots R, et al. Treatment of partial-thickness burns: a prospective randomized trial using TransCyte. ANZ J Surg 2004;74:622-6. [3] Costagliola M, Agrosi M. Second-degree burns: a comparative, multicenter, randomized trial of hyaluronic acid plus silver sulfadiazine vs silver sulfadiazine alone. Curr Med Res Opin 2005;21:1235-40. [4] Soroff HS, Sasvary D. Collagenase ointment and polymyxin B sulfate/ bacitracin spray versus silver sulfadiazine cream in partial thickness burns: a pilot study. J Burn Care Rehabil 1994;15:13-7. [5] Chung DH, Herndon DN. Burns. In: Holcomb III GW, Murphy JP, editors. Ashcraft's pediatric surgery. 5th Edition. Philadelphia (Pa): Saunders Elsevier; 2010. p. 154-66. [6] Wasiak J, Cleland H, Campbell F. Dressings for superficial and partial thickness burns. Cochrane Database Syst Rev 2008;4:CD002106. [7] Hansbrough JF, Achauer B, Dawson J, et al. Wound healing in partialthickness burn wounds treated with collagenase ointment versus silver sulfadiazine cream. J Burn Care Rehabil 1995;16:241-7. [8] Ozcan C, Erqun O, Celik A, et al. Enzymatic debridement of burn wounds with collagenase in children with partial thickness burns. Burns 2002;28:791-4. [9] Atiyeh BS, Costagliola M, Hayek SN, et al. Effect of silver on burn wound infection control and healing: review of the literature. Burns 2007;33:139-48. [10] Glat PM, Kubat WD, Hsu JF, et al. Randomized clinical study of SilvaSorb gel in comparison to Silvadene silver suilfadiazine cream in the management of partial-thickness burns. J Burn Care Res 2009;30: 262-7. [11] Cubison TC, Pape SA, Parkhouse N. Evidence for the link between healing time and the development of hypertrophic scars (HTS) in paediatric burns due to scald injury. Burns 2006;32:992-9.