Best Method of Burn Wound Care: A Prospective Randomized Trial
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Best Method of Burn Wound Care: A Prospective Randomized Trial|
- Time to healing [ Time Frame: 30-day ] [ Designated as safety issue: Yes ]Time from burn injury to healing (defined as at least 90% epithelialization) as determined by hospital records, outpatient clinical records and telephone contact (with subject or next-of-kin) per study protocol.
- Mortality [ Time Frame: 30-day ] [ Designated as safety issue: Yes ]Mortality within 30 days of burn injury, as determined by hospital records, outpatient clinical records and telephone contact (with next-of-kin) per study protocol.
- Burn wound infection rate [ Time Frame: 30-day ] [ Designated as safety issue: Yes ]Clinical suspicion of infection defined by presence of (a) burn wound cellulitis (erythema and/or edema AND pain and/or tenderness at the border of the wound), or (b) burn wound infection (change in appearance of the burn including focal or multifocal brown, black or violaceous discoloration OR rapid separation of the eschar OR conversion of partial thickness to full thickness burn).
- Microbiologic profile of clinical infections [ Time Frame: 30-day ] [ Designated as safety issue: Yes ]Qualitative microbiologic culture results and sensitivity panels from surface swabs taken from infected burn wounds (as defined by clinical criteria described in the secondary outcome "burn wound infection rate").
- Number of surgical procedures [ Time Frame: 30-day ] [ Designated as safety issue: Yes ]Number of surgical procedures required including indication and type of procedure.
- percent skin graft survival [ Time Frame: 30-day ] [ Designated as safety issue: Yes ]Percent survival (defined as area surviving / total area grafted at 7 days) of skin grafts.
- Hospital length of stay [ Time Frame: 30-day ] [ Designated as safety issue: Yes ]Length of stay during initial hospitalization.
|Study Start Date:||June 2015|
|Estimated Study Completion Date:||July 2016|
|Estimated Primary Completion Date:||June 2016 (Final data collection date for primary outcome measure)|
Active Comparator: Closed method
Burn patients randomized to closed method of burn wound care.
Procedure: Closed method
Subjects will have their wounds managed by covering with gauze and changing this gauze 3 to 7 times per week.
Experimental: Open method
Burn patients randomized to the open method of burn wound care.
Procedure: Open method
Subjects will have their burns managed by keeping the wounds exposed to the air.
Other Name: Exposure method
Participants: Patients presenting to Kamuzu Central Hospital in Lilongwe Malawi with burn wounds occuring within 72 hours of admission.
Procedures (methods): This is a prospective randomized trial. Subjects will be randomized during admission to receive either open dressing care or closed dressing care of their burn wounds.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01750034
|Principal Investigator:||Jared Gallaher, MD||UNC Chapel Hill Department of Surgery|