Best Method of Burn Wound Care: A Prospective Randomized Trial

Study Overview
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Brief Summary
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The purpose of this study is to better understand how to best care for burn wounds.

Detailed Description
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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.

Official Title
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Best Method of Burn Wound Care: A Prospective Randomized Trial

Conditions
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Burns

Intervention / Treatment
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* Procedure: Closed method
* Procedure: Open method


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Burn wound admitted to the hospital Signed informed consent Burn wound occuring within 72 hours of admission Exclusion Criteria: Language other than Chichewa or English Inability to access of phone (required for follow-up)
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Closed method<br>Burn patients randomized to closed method of burn wound care. | Procedure: Closed method<br>* Subjects will have their wounds managed by covering with gauze and changing this gauze 3 to 7 times per week.<br>* Other names: Dressing method;|
| Experimental: Open method<br>Burn patients randomized to the open method of burn wound care. | Procedure: Open method<br>* Subjects will have their burns managed by keeping the wounds exposed to the air.<br>* Other names: Exposure method;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time to healing | 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. | 30-day | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mortality | 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. | 30-day | 
| Burn wound infection rate | 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). | 30-day | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Burns, Wounds and injuries, Bandages