Hongtai Tang1, Guozhong Lv, Jinfeng Fu, Xihua Niu, Yeyang Li, Mei Zhang, Guoʼan Zhang, Dahai Hu, Xiaodong Chen, Jin Lei, Hongyan Qi, Zhaofan Xia. 1. From the Department of Burn Surgery (H.T., Z.X., M.Z.), Changhai Hospital, Second Military Medical University, Shanghai; Department of Burn Surgery (G.L.), the 3rd People's Hospital of Wuxi, Jiangsu; Department of Burn Surgery (J.F.), the 2nd Affiliated Hospital of Kunming Medical University, Yunnan; Department of Burn Surgery (X.N.), the 1st People's Hospital of ZhengZhou, Henan; Department of Burn Surgery (Y.L.), Guangzhou Red Cross Hospital, Guangdong; Department of Burn Surgery (G.Z.), Beijing Jishuitan Hospital, Beijing; Department of Burn Surgery (D.H.), Xijing Hospital, Shaanxi; Department of Burn Surgery (X.C.), the First People's Hospital of Fushan, Guangdong; Shanxi Province Burn Care Center (J.L.), Shanxi; and Department of Burn Surgery (H.Q.), Beijing Children's Hospital, Beijing, China.
Abstract
BACKGROUND: Partial-thickness burns are among the most frequently encountered types of burns, and numerous dressing materials are available for their treatment. A multicenter, open, randomized, and parallel study was undertaken to determine the efficacy and tolerability of silver sulfadiazine (SSD) compared with an absorbent foam silver dressing, Mepilex Ag, on patients aged between 5 years and 65 years with deep partial-thickness thermal burn injuries (2.5-25% total body surface area). METHODS: Patients were randomly assigned to either SSD (n = 82) applied daily or a Mepilex Ag dressing (n = 71) applied every 5 days to 7 days. The treatment period was up to 4 weeks. RESULTS: There was no significant difference between the two treatment groups with respect to the primary end point of time to healing, which occurred in 56 (79%) of 71 patients after a median follow-up time of 15 days in the Mepilex Ag group compared with 65 (79%) of 82 patients after a median follow-up time of 16 days in the SSD group (p = 0.74). There was also no significant difference in the percentage of study burn healed. Patients in the Mepilex Ag group had 87.1% of their study burn healed (out of the total burn area) compared with 85.2% of patients in the SSD group. However, the mean total number of dressings used was significantly more in the SSD group (14.0) compared with the Mepilex Ag group (3.06, p < 0.0001). There was no significant difference in the time until skin graft was performed between the two study groups. CONCLUSION: There was no difference in healing rates between Mepilex Ag and SSD, with both products well tolerated. The longer wear time of Mepilex Ag promotes undisturbed healing and makes it easier for patients to continue with their normal lives sooner. LEVEL OF EVIDENCE: Therapeutic study, level III.
RCT Entities:
BACKGROUND: Partial-thickness burns are among the most frequently encountered types of burns, and numerous dressing materials are available for their treatment. A multicenter, open, randomized, and parallel study was undertaken to determine the efficacy and tolerability of silver sulfadiazine (SSD) compared with an absorbent foam silver dressing, Mepilex Ag, on patients aged between 5 years and 65 years with deep partial-thickness thermal burn injuries (2.5-25% total body surface area). METHODS:Patients were randomly assigned to either SSD (n = 82) applied daily or a Mepilex Ag dressing (n = 71) applied every 5 days to 7 days. The treatment period was up to 4 weeks. RESULTS: There was no significant difference between the two treatment groups with respect to the primary end point of time to healing, which occurred in 56 (79%) of 71 patients after a median follow-up time of 15 days in the Mepilex Ag group compared with 65 (79%) of 82 patients after a median follow-up time of 16 days in the SSD group (p = 0.74). There was also no significant difference in the percentage of study burn healed. Patients in the Mepilex Ag group had 87.1% of their study burn healed (out of the total burn area) compared with 85.2% of patients in the SSD group. However, the mean total number of dressings used was significantly more in the SSD group (14.0) compared with the Mepilex Ag group (3.06, p < 0.0001). There was no significant difference in the time until skin graft was performed between the two study groups. CONCLUSION: There was no difference in healing rates between Mepilex Ag and SSD, with both products well tolerated. The longer wear time of Mepilex Ag promotes undisturbed healing and makes it easier for patients to continue with their normal lives sooner. LEVEL OF EVIDENCE: Therapeutic study, level III.
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