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Cosmetic and Functional Sequelae in Hand Burns. (AdipoSCAR)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05977595
Recruitment Status : Active, not recruiting
First Posted : August 4, 2023
Last Update Posted : November 13, 2023
Sponsor:
Information provided by (Responsible Party):
Hospices Civils de Lyon

Study Description
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Brief Summary:

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.


Condition or disease Intervention/treatment
Hand Burn Other: Quick DASH Score Visual Analog Scale Scar quality Healing Number of surgeries

Study Design
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Study Type : Observational
Estimated Enrollment : 50 participants
Observational Model: Cohort
Time Perspective: Retrospective
Official Title: A Descriptive Study of the Cosmetic and Functional Sequelae of Patients Who Received Releasing Incisions in the Management of Acute Upper Limb Burns.
Actual Study Start Date : January 1, 2019
Actual Primary Completion Date : June 1, 2023
Estimated Study Completion Date : December 1, 2023

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Burns Cosmetics Scars

Groups and Cohorts
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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.
 Other: Quick DASH Score Visual Analog Scale Scar quality Healing Number of surgeries
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.


Outcome Measures
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Primary Outcome Measures :
  1. 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.


  2. Healing assessment [ Time Frame: Through the completion of study, average 6 months ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Adult subjects, who were hospitalized at the Pierre Colson Burn Center (University Hospital) with a hand burn that required discharge incisions between January 2019 and June 2023.
Criteria

  • 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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05977595


Locations
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France
Edouard Herriot University hospital
Lyon, France, 69003
Sponsors and Collaborators
Hospices Civils de Lyon
More Information
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Responsible Party: Hospices Civils de Lyon
ClinicalTrials.gov Identifier: NCT05977595    
Other Study ID Numbers: 69HCL23_0747
First Posted: August 4, 2023    Key Record Dates
Last Update Posted: November 13, 2023
Last Verified: July 2023

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Hospices Civils de Lyon:
burns
hands
functional outcomes
skin graft
releasing incisions
Additional relevant MeSH terms:
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Burns
Wounds and Injuries