Best Method of Burn Wound Care: A Prospective Randomized Trial

Burns Clinical Trial

Official title:

Best Method of Burn Wound Care: A Prospective Randomized Trial

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT01750034
• Other study ID #: 12-2288
• Status: Withdrawn
• Phase: N/A
• First received: December 12, 2012
• Last updated: September 2, 2015
• Start date: June 2015
• Est. completion date: July 2016

Study information

• Verified date: September 2015
• Source: University of North Carolina, Chapel Hill
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: July 2016
• Est. primary completion date: June 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Burns

Intervention

Procedure:
• Closed method
Subjects will have their wounds managed by covering with gauze and changing this gauze 3 to 7 times per week.
• Open method
Subjects will have their burns managed by keeping the wounds exposed to the air.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
University of North Carolina, Chapel Hill

References & Publications (5)

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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	Yes
Other	Number of surgical procedures	Number of surgical procedures required including indication and type of procedure.	30-day	Yes
Other	percent skin graft survival	Percent survival (defined as area surviving / total area grafted at 7 days) of skin grafts.	30-day	Yes
Other	Hospital length of stay	Length of stay during initial hospitalization.	30-day	Yes
Primary	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	Yes
Secondary	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	Yes
Secondary	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	Yes