NCT05977595

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
50

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jan 2019

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2019

Completed
4.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2023

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

July 26, 2023

Completed
9 days until next milestone

First Posted

Study publicly available on registry

August 4, 2023

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2023

Completed
Last Updated

November 13, 2023

Status Verified

July 1, 2023

Enrollment Period

4.4 years

First QC Date

July 26, 2023

Last Update Submit

November 9, 2023

Conditions

Keywords

burnshandsfunctional outcomesskin graftreleasing incisions

Outcome Measures

Primary Outcomes (2)

  • 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

  • Healing assessment

    Through the completion of study, average 6 months

Study Arms (1)

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

Interventions

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.

Deep hand burns

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

  • 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.

You may not qualify if:

  • Patient refusal
  • Less than 1 month follow-up or death within the first month

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Edouard Herriot University hospital

Lyon, 69003, France

Location

MeSH Terms

Conditions

Burns

Condition Hierarchy (Ancestors)

Wounds and Injuries

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 26, 2023

First Posted

August 4, 2023

Study Start

January 1, 2019

Primary Completion

June 1, 2023

Study Completion

December 1, 2023

Last Updated

November 13, 2023

Record last verified: 2023-07

Locations