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Best Method of Burn Wound Care: A Prospective Randomized Trial

Primary Purpose

Burns

Status
Withdrawn
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Closed method
Open method
Sponsored by
University of North Carolina, Chapel Hill
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Burns focused on measuring Burns, Wounds and injuries, Bandages

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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)

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Active Comparator

    Experimental

    Arm Label

    Closed method

    Open method

    Arm Description

    Burn patients randomized to closed method of burn wound care.

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

    Outcomes

    Primary Outcome Measures

    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.

    Secondary Outcome Measures

    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.
    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).

    Full Information

    First Posted
    December 12, 2012
    Last Updated
    September 2, 2015
    Sponsor
    University of North Carolina, Chapel Hill
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    1. Study Identification

    Unique Protocol Identification Number
    NCT01750034
    Brief Title
    Best Method of Burn Wound Care: A Prospective Randomized Trial
    Official Title
    Best Method of Burn Wound Care: A Prospective Randomized Trial
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    September 2015
    Overall Recruitment Status
    Withdrawn
    Why Stopped
    Feasibility issues
    Study Start Date
    June 2015 (undefined)
    Primary Completion Date
    June 2016 (Anticipated)
    Study Completion Date
    July 2016 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    University of North Carolina, Chapel Hill

    4. Oversight

    Data Monitoring Committee
    Yes

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Burns
    Keywords
    Burns, Wounds and injuries, Bandages

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    0 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Closed method
    Arm Type
    Active Comparator
    Arm Description
    Burn patients randomized to closed method of burn wound care.
    Arm Title
    Open method
    Arm Type
    Experimental
    Arm Description
    Burn patients randomized to the open method of burn wound care.
    Intervention Type
    Procedure
    Intervention Name(s)
    Closed method
    Other Intervention Name(s)
    Bandage method, Dressing method
    Intervention Description
    Subjects will have their wounds managed by covering with gauze and changing this gauze 3 to 7 times per week.
    Intervention Type
    Procedure
    Intervention Name(s)
    Open method
    Other Intervention Name(s)
    Exposure method
    Intervention Description
    Subjects will have their burns managed by keeping the wounds exposed to the air.
    Primary Outcome Measure Information:
    Title
    Time to healing
    Description
    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.
    Time Frame
    30-day
    Secondary Outcome Measure Information:
    Title
    Mortality
    Description
    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.
    Time Frame
    30-day
    Title
    Burn wound infection rate
    Description
    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).
    Time Frame
    30-day
    Other Pre-specified Outcome Measures:
    Title
    Microbiologic profile of clinical infections
    Description
    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").
    Time Frame
    30-day
    Title
    Number of surgical procedures
    Description
    Number of surgical procedures required including indication and type of procedure.
    Time Frame
    30-day
    Title
    percent skin graft survival
    Description
    Percent survival (defined as area surviving / total area grafted at 7 days) of skin grafts.
    Time Frame
    30-day
    Title
    Hospital length of stay
    Description
    Length of stay during initial hospitalization.
    Time Frame
    30-day

    10. Eligibility

    Sex
    All
    Accepts Healthy Volunteers
    No
    Eligibility 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)
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Jared Gallaher, MD
    Organizational Affiliation
    UNC Chapel Hill Department of Surgery
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Citations:
    PubMed Identifier
    18226462
    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.
    Results Reference
    background
    PubMed Identifier
    6074149
    Citation
    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.
    Results Reference
    background
    PubMed Identifier
    13275898
    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. doi: 10.1097/00000658-195601000-00006. No abstract available.
    Results Reference
    background
    PubMed Identifier
    23142508
    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.
    Results Reference
    background
    PubMed Identifier
    21819720
    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. doi: 10.1177/147323001103900321.
    Results Reference
    background

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    Best Method of Burn Wound Care: A Prospective Randomized Trial

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