Karin R Wiese1, Marcus van Heukelum1, Carl J Lombard2,3, Nando Ferreira1, Marilize C Burger1. 1. Division of Orthopaedic Surgery, Department of Surgical Sciences, Faculty of Medicine and Health Sciences, Stellenbosch University, Cape Town, South Africa. 2. Division of Epidemiology and Biostatistics, Department of Global Health, Faculty of Medicine and Health Sciences, Stellenbosch University, Cape Town, South Africa; and. 3. Biostatistics Unit, South African Medical Research Council, Cape Town, South Africa.
Abstract
OBJECTIVES: To investigate, in patients with fracture blisters, the time to surgical readiness in those treated with silver-impregnated fibrous hydrocolloid (SFH) dressings compared with those treated with topical silver sulfadiazine (SS) cream and to determine the direct costs associated with both treatments. DESIGN: A single-blind, randomized controlled trial. SETTING: The study was conducted at Tygerberg Hospital, a tertiary care facility, and Worcester Provincial Hospital, a secondary care facility, Western Cape, South Africa. PATIENTS: Patients >18 years of age with one or more fracture blisters overlying fractures requiring surgical fixation were considered for inclusion. MAIN OUTCOME MEASUREMENTS: The main outcome was the time to surgical readiness, after complete re-epithelialization of the affected site, in both groups. The direct cost associated with each treatment and the daily cost associated with hospital stay per day were recorded. RESULTS: At an interim analysis, 70 patients had been enrolled and completed the study protocol with 35 patients per group. Groups were balanced across patient and clinical demographic characteristics. A significant difference of 4 days (95% confidence interval: 2.9-5.1 days, P < 0.001) in the mean time to surgical readiness (SFH group, 5.3 days vs. SS group, 9.3 days) was observed. No difference between the time to surgical procedure as well as the total length of hospital stay between the 2 groups was observed. CONCLUSION: This study reports that SFH dressings are a cost-effective treatment option for the management of fracture blisters evidenced by a significant accelerated time to blister re-epithelialization compared with a commonly described method of SS cream dressings. LEVEL OF EVIDENCE: Therapeutic Level 1. See Instructions for Authors for a complete description of levels of evidence. LEVEL OF EVIDENCE: Therapeutic Level I. See Instructions for Authors for a complete description of levels of evidence.
RCT Entities:
OBJECTIVES: To investigate, in patients with fracture blisters, the time to surgical readiness in those treated with silver-impregnated fibrous hydrocolloid (SFH) dressings compared with those treated with topical silver sulfadiazine (SS) cream and to determine the direct costs associated with both treatments. DESIGN: A single-blind, randomized controlled trial. SETTING: The study was conducted at Tygerberg Hospital, a tertiary care facility, and Worcester Provincial Hospital, a secondary care facility, Western Cape, South Africa. PATIENTS: Patients >18 years of age with one or more fracture blisters overlying fractures requiring surgical fixation were considered for inclusion. MAIN OUTCOME MEASUREMENTS: The main outcome was the time to surgical readiness, after complete re-epithelialization of the affected site, in both groups. The direct cost associated with each treatment and the daily cost associated with hospital stay per day were recorded. RESULTS: At an interim analysis, 70 patients had been enrolled and completed the study protocol with 35 patients per group. Groups were balanced across patient and clinical demographic characteristics. A significant difference of 4 days (95% confidence interval: 2.9-5.1 days, P < 0.001) in the mean time to surgical readiness (SFH group, 5.3 days vs. SS group, 9.3 days) was observed. No difference between the time to surgical procedure as well as the total length of hospital stay between the 2 groups was observed. CONCLUSION: This study reports that SFH dressings are a cost-effective treatment option for the management of fracture blisters evidenced by a significant accelerated time to blister re-epithelialization compared with a commonly described method of SS cream dressings. LEVEL OF EVIDENCE: Therapeutic Level 1. See Instructions for Authors for a complete description of levels of evidence. LEVEL OF EVIDENCE: Therapeutic Level I. See Instructions for Authors for a complete description of levels of evidence.