Best Method of Burn Wound Care: A Prospective Randomized Trial

NCT ID: NCT01750034

Last Updated: 2015-09-04

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

NA

Study Classification

INTERVENTIONAL

Study Start Date

2015-06-30

Study Completion Date

2016-07-31

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.

Conditions

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Burns

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Closed method

Burn patients randomized to closed method of burn wound care.

Group Type ACTIVE_COMPARATOR

Closed method

Intervention Type PROCEDURE

Subjects will have their wounds managed by covering with gauze and changing this gauze 3 to 7 times per week.

Open method

Burn patients randomized to the open method of burn wound care.

Group Type EXPERIMENTAL

Open method

Intervention Type PROCEDURE

Subjects will have their burns managed by keeping the wounds exposed to the air.

Interventions

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Closed method

Subjects will have their wounds managed by covering with gauze and changing this gauze 3 to 7 times per week.

Intervention Type PROCEDURE

Open method

Subjects will have their burns managed by keeping the wounds exposed to the air.

Intervention Type PROCEDURE

Other Intervention Names

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Bandage method Dressing method Exposure method

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)
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of North Carolina, Chapel Hill

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Jared Gallaher, MD

Role: PRINCIPAL_INVESTIGATOR

UNC Chapel Hill Department of Surgery

References

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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.

Reference Type BACKGROUND
PMID: 18226462 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 6074149 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 13275898 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 23142508 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 21819720 (View on PubMed)

Other Identifiers

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12-2288

Identifier Type: -

Identifier Source: org_study_id

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