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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT05977595
Other study ID # 69HCL23_0747
Secondary ID
Status Active, not recruiting
Phase
First received
Last updated
Start date January 1, 2019
Est. completion date December 1, 2023

Study information

Verified date July 2023
Source Hospices Civils de Lyon
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


Recruitment information / eligibility

Status Active, not recruiting
Enrollment 50
Est. completion date December 1, 2023
Est. primary completion date June 1, 2023
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility - 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 Design


Related Conditions & MeSH terms


Intervention

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.

Locations

Country Name City State
France Edouard Herriot University hospital Lyon

Sponsors (1)

Lead Sponsor Collaborator
Hospices Civils de Lyon

Country where clinical trial is conducted

France, 

Outcome

Type Measure Description Time frame Safety issue
Primary Functional score 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
Primary Healing assessment Through the completion of study, average 6 months
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