- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05977595
Cosmetic and Functional Sequelae in Hand Burns. (AdipoSCAR)
A Descriptive Study of the Cosmetic and Functional Sequelae of Patients Who Received Releasing Incisions in the Management of Acute Upper Limb Burns.
Although it represents a small percentage of the body surface, the hand is the most exposed part of the body after the face and neck and is one of the area's most frequently involved in burns. It has a social function, but above all, a functionnal one. An optimized reconstruction of this area after the burn allow the patient to recover the best possible function and increase his chances of returning to professional activity and daily life. Advances in burn treatment, such as improved resuscitation management, rapid excision of burns, skin grafting, regular dressings, and improved metabolic support, have reduced the morbidity and mortality of severe burns. However, significant challenges remain.
The hand is the most frequently involved area in burns and is affected in 90% of severe burns. Hand burns requiring releasing incisions are circular, deep burns and represent a significant functional challenge. In the acute setting, current treatment options must prevent complications associated with disruption of the skin's protective function. In the longer term, these treatments should allow the regeneration of fully functional skin. However, some sequelae may persist in the form of sensory deficits, residual pain, retractile scars hindering function in this highly mobile area, or even aesthetic sequelae.
The aim of our study was to perform a descriptive analysis of the aesthetic and functional sequelae related to hand burns that required acute realeasing incisions using objective and subjective tools available in the medical records (demographic, clinical and follow-up data in the context of routine care). This retrospective, non-interventional, data-driven study would provide an overview of the sequelae of hand burns with current therapies.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Estimated)
Contacts and Locations
Study Locations
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-
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Lyon, France, 69003
- Recruiting
- Edouard Herriot University Hospital
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Contact:
- Camille BRENAC, Dr
- Phone Number: +33 679992181
- Email: camille.brenac@chu-lyon.fr
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Contact:
- Alain Ali MOJALLAL, Dr
- Phone Number: +33 426732822
- Email: alain-ali.mojallal@chu-lyon.fr
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria :
- Adult patients
- Acute burn (less than 3 days)
- Burns of one or both hands or finger burns
- Skin surface burned less than 40% of the body
- Chemical, thermal, or electrical burns of the hand.
- Burn that required a skin graft.
Exclusion Criteria :
- Patient refusal
- Less than 1 month follow-up or death within the first month
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
Deep hand burns
Adult subjects, who were hospitalized at the Pierre Colson Burn Center with a hand burn that required releasing incisions.
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Functional and aesthetic criteria : Quick DASH Score at 3 month and 6 months, Visual Analog Scale at 3 month and 6 months, scar quality (assessment by surgeon), healing (discontinuation of dressings), need for a second surgical procedure.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Functional score
Time Frame: Through the completion of study, average 6 months
|
Functional recovery at 3 months and 6 months after the burn (functional score, return to activities) Healing time (discontinuation of dressings). Scar quality (hypertrophic, retractile, surgical revision necessary and surgery of sequela). Burn VAS (1-10) at 3 and 6 months. QuickDASH Score at 3 and 6 months. Scar quality at 6 months. Burn VAS at 3 months and 6 months. |
Through the completion of study, average 6 months
|
|
Healing assessment
Time Frame: Through the completion of study, average 6 months
|
Through the completion of study, average 6 months
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 69HCL23_0747
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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