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Best Method of Burn Wound Care: A Prospective Randomized Trial

Best Method of Burn Wound Care: A Prospective Randomized Trial

Status
Withdrawn
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01750034
Enrollment
0
Registered
2012-12-17
Start date
2015-06-30
Completion date
2016-07-31
Last updated
2015-09-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Burns

Keywords

Burns, Wounds and injuries, Bandages

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.

Interventions

PROCEDUREClosed method

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

PROCEDUREOpen method

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

Sponsors

University of North Carolina, Chapel Hill
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Healthy volunteers
No

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)

Design outcomes

Primary

MeasureTime frameDescription
Time to healing30-dayTime 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

MeasureTime frameDescription
Mortality30-dayMortality 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 rate30-dayClinical 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).

Other

MeasureTime frameDescription
Microbiologic profile of clinical infections30-dayQualitative 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).
Hospital length of stay30-dayLength of stay during initial hospitalization.
Number of surgical procedures30-dayNumber of surgical procedures required including indication and type of procedure.
percent skin graft survival30-dayPercent survival (defined as area surviving / total area grafted at 7 days) of skin grafts.

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026