BurnsNCT01750034
Best Method of Burn Wound Care: A Prospective Randomized Trial
A study testing Closed method and Open method in people with Burns, run by University of North Carolina, Chapel Hill.
Trial summary
The purpose of this study is to better understand how to best care for burn wounds. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Burns
- What is being tested?
- Closed method and Open method
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Jun 2015to Jul 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Burn wound admitted to the hospital
- Signed informed consent
- Burn wound occuring within 72 hours of admission
Who cannot join
- Language other than Chichewa or English
- Inability to access of phone (required for follow-up)
About this study
The purpose of this study is to better understand how to best care for burn wounds.
Read the 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.
- Conditions
- Burns
- Being tested
- Closed method, Open method
- Keywords
- Burns, Wounds and injuries, Bandages
- Medical subject headings
- Burns, Wounds and Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Closed methodProcedure or surgery
Also called Bandage method, Dressing method
Subjects will have their wounds managed by covering with gauze and changing this gauze 3 to 7 times per week.
Open methodProcedure or surgery
Also called Exposure method
Subjects will have their burns managed by keeping the wounds exposed to the air.
| Study group | Role | What they receive |
|---|---|---|
| Closed method | Active comparator | Burn patients randomized to closed method of burn wound care. Receives: Procedure: Closed method |
| Open method | Experimental | Burn patients randomized to the open method of burn wound care. Receives: Procedure: Open method |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 30-day
Secondary outcomes (2)
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.
Measured: 30-day
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).
Measured: 30-day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Dec 2012 (estimated)
- Study startJun 2015
- Primary completionJun 2016 (estimated)
- Study completionJul 2016 (estimated)
Why it stopped: Feasibility issues
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for BurnsStudies of the same condition, open and under way.
- More trials run by University of North Carolina, Chapel HillThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of North Carolina, Chapel Hill
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jared Gallaher, MD, Principal investigator, UNC Chapel Hill Department of Surgery
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01750034
- Sponsor's protocol ID
- 12-2288
- Status last verified
- Sep 2015
- First submitted
- 12 Dec 2012
- Last updated
- 4 Sep 2015
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 18226462Dominguez 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.
PubMed 6074149HOLMAN 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.
PubMed 13275898Kiser 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.
PubMed 23142508Samuel 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.
PubMed 21819720
Study at a glance
From the registry record, last updated by the sponsor on 4 Sep 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Best Method of Burn Wound Care: A Prospective Randomized Trial
- ClinicalTrials.gov ID
- NCT01750034
- Acronym / sponsor ID
- 12-2288
- Conditions
- Burns
- Keywords
- Burns, Wounds and injuries, Bandages
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Feasibility issues
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University of North Carolina, Chapel HillUniversity, hospital or other
- Study start
- Jun 2015
- Primary completion
- Jun 2016 (estimated)
- Study completion
- Jul 2016 (estimated)
- First posted
- 17 Dec 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Closed method | Active comparator | Procedure: Closed methodBurn patients randomized to closed method of burn wound care. |
| Open method | Experimental | Procedure: Open methodBurn patients randomized to the open method of burn wound care. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- Burn wound admitted to the hospital
- Signed informed consent
- Burn wound occuring within 72 hours of admission
Key exclusion criteria (2 listed)
- Language other than Chichewa or English
- Inability to access of phone (required for follow-up)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Closed methodAlso: Bandage method, Dressing methodSubjects will have their wounds managed by covering with gauze and changing this gauze 3 to 7 times per week. | Procedure or surgery | Closed method |
| Open methodAlso: Exposure methodSubjects will have their burns managed by keeping the wounds exposed to the air. | Procedure or surgery | Open method |
Primary outcome
Time to healing
Time frame: 30-day
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.
2 secondary outcomes
Mortality
Time frame: 30-day
Burn wound infection rate
Time frame: 30-day
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Sep 2015.
- Background: PubMed 18226462Gosselin 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.
- Background: PubMed 6074149Dominguez 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.
- Background: PubMed 13275898HOLMAN 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.
- Background: PubMed 23142508Kiser 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.
- Background: PubMed 21819720Samuel 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jared Gallaher, MD principal investigator
UNC Chapel Hill Department of Surgery
Questions about this trial
What is this clinical trial studying?
A study testing Closed method and Open method in people with Burns, run by University of North Carolina, Chapel Hill.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 4 Sep 2015. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time to healing (time frame: 30-day). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01750034, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Sep 2015.