Best Method of Burn Wound Care: A Prospective Randomized Trial

NCT01750034 | Withdrawn DMC

• 1 other identifier: 12-2288
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

Brief Summary

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

Conditions

Burns

Keywords

Burns; Wounds and injuries; Bandages

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Mortality

  30-day

• Burn wound infection rate

  30-day

Other Outcomes (4)

• Microbiologic profile of clinical infections

  30-day

• Number of surgical procedures

  30-day

• percent skin graft survival

  30-day

Study Arms (2)

Closed method

ACTIVE COMPARATOR

Burn patients randomized to closed method of burn wound care.

Procedure: Closed method

Open method

EXPERIMENTAL

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

Procedure: Open method

Interventions

Closed method PROCEDURE

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

Also known as: Bandage method, Dressing method

Closed method

Open method PROCEDURE

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

Also known as: Exposure method

Open method

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• University of North Carolina, Chapel Hill: lead

Related Publications (5)

• 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.

  PMID: 18226462 BACKGROUND

• 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.

  PMID: 6074149 BACKGROUND

• 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.

  PMID: 13275898 BACKGROUND

• 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.

  PMID: 23142508 BACKGROUND

• 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.

  PMID: 21819720 BACKGROUND

MeSH Terms

Conditions

Burns; Wounds and Injuries

Study Officials

• Jared Gallaher, MD

  UNC Chapel Hill Department of Surgery

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 12, 2012
• First Posted: December 17, 2012
• Study Start: June 1, 2015
• Primary Completion: June 1, 2016
• Study Completion: July 1, 2016
• Last Updated: September 4, 2015

Record last verified: 2015-09