Best Method of Burn Wound Care: A Prospective Randomized Trial

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

Study Overview

• Status: Withdrawn
• Conditions: Burns
• Intervention / Treatment: Procedure: Closed method; Procedure: Open method

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 Type: Interventional
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: ADULT; OLDER_ADULT; CHILD
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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.; Other Names: Bandage method; Dressing method
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 Names: Exposure method

What is the study measuring?

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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Microbiologic profile of clinical infections	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").	30-day
Number of surgical procedures	Number of surgical procedures required including indication and type of procedure.	30-day
percent skin graft survival	Percent survival (defined as area surviving / total area grafted at 7 days) of skin grafts.	30-day
Hospital length of stay	Length of stay during initial hospitalization.	30-day

Collaborators and Investigators

• Sponsor: University of North Carolina, Chapel Hill
• Investigators: Principal Investigator: Jared Gallaher, MD, UNC Chapel Hill Department of Surgery

Publications and helpful links

General Publications

• Gosselin RA, Kuppers B. Open versus closed management of burn wounds in a low-income developing country. Burns. 2008 Aug;34(5):644-7. doi: 10.1016/j.burns.2007.09.013. Epub 2008 Jan 15.
• Dominguez O, Bains JW, Lynch JB, Lewis SR. Treatment of burns with silver nitrate versus exposure method: analysis of 200 patients. Plast Reconstr Surg. 1967 Nov;40(5):489-93. doi: 10.1097/00006534-196711000-00012. No abstract available.
• HOLMAN SP, SHAYA ES, HOFFMEISTER FS, EDGERTON MT Jr. Studies on burns. I. The exposure method vs. occlusive dressings in the local treatment of experimental burns. Ann Surg. 1956 Jan;143(1):49-56. doi: 10.1097/00000658-195601000-00006. No abstract available.
• Kiser MM, Samuel JC, Mclean SE, Muyco AP, Cairns BA, Charles AG. Epidemiology of pediatric injury in Malawi: burden of disease and implications for prevention. Int J Surg. 2012;10(10):611-7. doi: 10.1016/j.ijsu.2012.10.004. Epub 2012 Nov 7.
• Samuel JC, Campbell EL, Mjuweni S, Muyco AP, Cairns BA, Charles AG. The epidemiology, management, outcomes and areas for improvement of burn care in central Malawi: an observational study. J Int Med Res. 2011;39(3):873-9. doi: 10.1177/147323001103900321.

Study record dates

Study Major Dates

• Study Start: June 1, 2015
• Primary Completion (ANTICIPATED): June 1, 2016
• Study Completion (ANTICIPATED): July 1, 2016

Study Registration Dates

• First Submitted: December 12, 2012
• First Submitted That Met QC Criteria: December 12, 2012
• First Posted (ESTIMATE): December 17, 2012

Study Record Updates

• Last Update Posted (ESTIMATE): September 4, 2015
• Last Update Submitted That Met QC Criteria: September 2, 2015
• Last Verified: September 1, 2015

More Information

Terms related to this study

• Keywords: Burns; Bandages; Wounds and injuries
• Additional Relevant MeSH Terms: Wounds and Injuries; Burns
• Other Study ID Numbers: 12-2288