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Best Method of Burn Wound Care: A Prospective Randomized Trial

This study is not yet open for participant recruitment.
Verified December 2012 by University of North Carolina, Chapel Hill
Sponsor:
Information provided by (Responsible Party):
University of North Carolina, Chapel Hill
ClinicalTrials.gov Identifier:
NCT01750034
First received: December 12, 2012
Last updated: NA
Last verified: December 2012
History: No changes posted
  Purpose

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


Condition Intervention
Burns
 Procedure: Closed method
Procedure: Open method

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Best Method of Burn Wound Care: A Prospective Randomized Trial

Resource links provided by NLM:

MedlinePlus related topics: Burns Injuries Wounds
U.S. FDA Resources

Further study details as provided by University of North Carolina, Chapel Hill:

Primary Outcome Measures:
  • Time to healing [ Time Frame: 30-day ] [ Designated as safety issue: Yes ]
    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.


Secondary Outcome Measures:
  • Mortality [ Time Frame: 30-day ] [ Designated as safety issue: Yes ]
    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.

  • Burn wound infection rate [ Time Frame: 30-day ] [ Designated as safety issue: Yes ]
    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).


Other Outcome Measures:
  • Microbiologic profile of clinical infections [ Time Frame: 30-day ] [ Designated as safety issue: Yes ]
    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").

  • Number of surgical procedures [ Time Frame: 30-day ] [ Designated as safety issue: Yes ]
    Number of surgical procedures required including indication and type of procedure.

  • percent skin graft survival [ Time Frame: 30-day ] [ Designated as safety issue: Yes ]
    Percent survival (defined as area surviving / total area grafted at 7 days) of skin grafts.

  • Hospital length of stay [ Time Frame: 30-day ] [ Designated as safety issue: Yes ]
    Length of stay during initial hospitalization.


Estimated Enrollment: 200
Study Start Date: January 2013
Estimated Study Completion Date: January 2015
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: Exposure 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.

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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)
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01750034

Contacts
Contact: Jonathan C Samuel, MD, MPH +265 995730159 jsamuel@med.unc.edu
Contact: Jonathan C Samuel, MD, MPH 919 962 7555 jsamuel@med.unc.edu

Locations
Malawi
Kamuzu Central Hospital Not yet recruiting
Lilongwe, Malawi
Sub-Investigator: Jonathan C Samuel, MD, MPH            
Sponsors and Collaborators
University of North Carolina, Chapel Hill
Investigators
Principal Investigator: Jonathan C Samuel, MD, MPH UNC Chapel Hill Department of Surgery
  More Information

Publications:

Responsible Party: University of North Carolina, Chapel Hill
ClinicalTrials.gov Identifier: NCT01750034     History of Changes
Other Study ID Numbers: 12-2288
Study First Received: December 12, 2012
Last Updated: December 12, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by University of North Carolina, Chapel Hill:
Burns
Wounds and injuries
Bandages

Additional relevant MeSH terms:
Burns
Wounds and Injuries

ClinicalTrials.gov processed this record on May 16, 2013