Best Method of Burn Wound Care: A Prospective Randomized Trial
|ClinicalTrials.gov Identifier: NCT01750034|
Recruitment Status : Withdrawn (Feasibility issues)
First Posted : December 17, 2012
Last Update Posted : September 4, 2015
|Condition or disease||Intervention/treatment||Phase|
|Burns||Procedure: Closed method Procedure: Open method||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||0 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Best Method of Burn Wound Care: A Prospective Randomized Trial|
|Study Start Date :||June 2015|
|Estimated Primary Completion Date :||June 2016|
|Estimated Study Completion Date :||July 2016|
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
- Time to healing [ Time Frame: 30-day ]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 ]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 ]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 ]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 ]Number of surgical procedures required including indication and type of procedure.
- percent skin graft survival [ Time Frame: 30-day ]Percent survival (defined as area surviving / total area grafted at 7 days) of skin grafts.
- Hospital length of stay [ Time Frame: 30-day ]Length of stay during initial hospitalization.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01750034
|Principal Investigator:||Jared Gallaher, MD||UNC Chapel Hill Department of Surgery|