Hand BurnAdipoSCARNCT05977595
Cosmetic and Functional Sequelae in Hand Burns.
An observational study of Hand Burn, run by Hospices Civils de Lyon at 1 site in France.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hand Burn
- What is being tested?
- Quick DASH Score Visual Analog Scale Scar quality Healing Number of surgeries
- How many people
- 50 participants
- Where
- 1 siteFrance
- Study dates
- 1 Jan 2019to 1 Dec 2023
- Phase
- Observational
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- Patient refusal
- Less than 1 month follow-up or death within the first month
Trial locations and contacts
1 site in 1 country.
About this study
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.
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.
- Conditions
- Hand Burn
- Being tested
- Quick DASH Score Visual Analog Scale Scar quality Healing Number of surgeries
- Keywords
- burns, hands, functional outcomes, skin graft, releasing incisions
- Medical subject headings
- Burns
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Quick DASH Score Visual Analog Scale Scar quality Healing Number of surgeriesOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Deep hand burns | Adult subjects, who were hospitalized at the Pierre Colson Burn Center with a hand burn that required releasing incisions. Receives: Other: Quick DASH Score Visual Analog Scale Scar quality Healing Number of surgeries |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Through the completion of study, average 6 months
Healing assessment
Measured: Through the completion of study, average 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Aug 2023
- Study start1 Jan 2019
- Primary completion1 Jun 2023
- Study completion1 Dec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hand BurnStudies of the same condition, open and under way.
- More trials run by Hospices Civils de LyonThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hospices Civils de Lyon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05977595
- Sponsor's protocol ID
- 69HCL23_0747
- Acronym
- AdipoSCAR
- Status last verified
- Jul 2023
- First submitted
- 26 Jul 2023
- Last updated
- 13 Nov 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT05977595
- Acronym / sponsor ID
- AdipoSCAR / 69HCL23_0747
- Conditions
- Hand Burn
- Keywords
- burns, hands, functional outcomes, skin graft, releasing incisions
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Hospices Civils de LyonUniversity, hospital or other
- Study start
- 1 Jan 2019 (actual)
- Primary completion
- 1 Jun 2023 (actual)
- Study completion
- 1 Dec 2023 (estimated)
- First posted
- 4 Aug 2023 (actual)
- 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.
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 design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Deep hand burns | – | Other: Quick DASH Score Visual Analog Scale Scar quality Healing Number of surgeriesAdult subjects, who were hospitalized at the Pierre Colson Burn Center with a hand burn that required releasing incisions. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (6 listed)
Key exclusion criteria (2 listed)
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 |
|---|---|---|
| Quick DASH Score Visual Analog Scale Scar quality Healing Number of surgeriesFunctional 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. | Other | Deep hand burns |
Primary outcome
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.
Healing assessment
Time frame: Through the completion of study, average 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Nov 2023.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hand Burn, run by Hospices Civils de Lyon at 1 site in France.
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 6 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: status not confirmed, as of the sponsor's last update on 13 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Results are not available in the source record.
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?
Functional score (time frame: Through the completion of study, average 6 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 13 Nov 2023.