Best Method of Burn Wound Care: A Prospective Randomized Trial

Not Applicable

Withdrawn

• Conditions: Burns
• Interventions: Procedure: Open method; Procedure: Closed method

• Registration Number: NCT01750034
• Lead Sponsor: University of North Carolina, Chapel Hill

Brief Summary

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

Detailed Description

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 Timeline

• Study First Submitted: 2012-12-12
• Study First Submitted QC: 2012-12-12
• Study First Posted: 2012-12-17
• Study Start: 2015-06
• Status Verified: 2015-09
• Last Update Submitted: 2015-09-02
• Last Update Posted: 2015-09-04
• Primary Completion: 2016-06
• Study Completion: 2016-07

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

• Burn wound admitted to the hospital
• Signed informed consent
• Burn wound occuring within 72 hours of admission

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Exclusion Criteria

• Language other than Chichewa or English
• Inability to access of phone (required for follow-up)

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Open method	Open method	Burn patients randomized to the open method of burn wound care.
Closed method	Closed method	Burn patients randomized to closed method of burn wound care.

Primary Outcome Measures

Name	Time	Method
Time to healing	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.

Secondary Outcome Measures

Name	Time	Method
Mortality	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	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).