Burn Contracture of SkinNCT05425433
Serial Casting for Upper Extremity Burn Contractures
A study testing Tailored serial casting intercention in people with Burn Contracture of Skin, run by Centre hospitalier de l'Université de Montréal (CHUM) at 1 site in Canada.
Trial summary
The use of a splint, serial casting and passive stretching have been described in the literature as conservative interventions to manage joint contractures after burn injury. There is a paucity of literature investigating the effect of serial casting on scar contractures following upper extremity (UE) burn injury in… Read more about this study
- Who is it for?
- Ages 16 to 100 years
- Conditions the study is for
- Burn Contracture of Skin
- What is being tested?
- Tailored serial casting intercention
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteCanada
- Study dates
- 20 Sep 2022to 20 Sep 2025
- Phase
- Interventional
- 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 16 to 100 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Burn survivors with >15% loss of PROM of their PIP, MCP, wrist, or elbow in either: flexion, extension, ulnar deviation or radial deviation.
- Fire, flame or scald burn injury
- -≥16 years old
- have provided informed consent.
Who cannot join
- Frostbite, chemical or electrical burn injury
- A premorbid musculoskeletal or neurological disorder that limited their ROM
- Have sustained a neurological injury secondary to the burn injury
- A psychiatric or cognitive disorder that limits their ability to follow the research protocol
- Have been diagnosed with heterotopic ossification
- PROM is contraindicated for any reason
- Do not understand English or French.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Should Serial Casting be a "First-resort" Conservative Treatment for Adults With Upper Extremity Burn Contractures?
The use of a splint, serial casting and passive stretching have been described in the literature as conservative interventions to manage joint contractures after burn injury. There is a paucity of literature investigating the effect of serial casting on scar contractures following upper extremity (UE) burn injury in adults and a lack of studies using strong methodological approaches. There are also no studies investigating the effect of casting on hypertrophic scars (HSc) and on self-reported UE function. This study is a longitudinal case series design with a criteria for change on the use of serial casting for the treatment of upper extremity burn contractures. The purpose of this study is to estimate the extent to which range of motion (AROM and PROM), scar characteristics and patient-reported upper-extremity function changes following an individually-tailored serial casting treatment program after switching from one week of usual care and to determine if these changes can be maintained 3 weeks after stopping serial casting, for adult burn survivors who developed an upper-extremity joint contracture greater than 15% normal range of motion within 1-year post-burn. This study will be a longitudinal case series design with a criteria for change. A minimum of 12 participants will be recruited from the "Centre d'expertise pour les victimes de brûlures graves de l'ouest du Québec" (CEVBGOQ) and will undergo one week of "usual care". If the PROM of the joint does not improve after one week of usual care, the participant will start the serial casting process, which will be prescribed by the treating OT. PROM/AROM and scar characteristics will be measured using a revised goniometry protocol that incorporates cutaneokinematics (CKM) principles and precise skin measures (DermaScan C, Cutometer®, Mexameter® and Tewameter®) at baseline, every Monday and Friday of the treatment weeks and 3 weeks after treatment cessation. Self-reported UE function and satisfaction related to scarring will be assessed at baseline and 3 weeks after treatment cessation using the QuickDASH and the patient satisfaction assessment scale (PSAS). Analysis on ROM and scar characteristic will be conducted using a graphical representation with a projected "usual care" regression line to count how many outcomes were over the line once the treatment was introduced. This study will contribute to building evidence for the use of serial casting following UE burn contractures in the adult population.
Read the detailed description
Participants will undergo a tailored intervention based on their needs.
- Conditions
- Burn Contracture of Skin
- Being tested
- Tailored serial casting intercention
- Keywords
- Burns, Burn Rehabilitation, Serial Casting
- Medical subject headings
- Burns
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tailored serial casting intercentionOther
Every participant will undergo 1 week of usual care for the affected joint according to the OT's prescription (static progressive, dynamic or serial static) combined with stretching, moisturizers, pressure therapy, or thermal modalities. After the one week of splinting, if the PROM of the targeted joint does not improve, the participant will start serial casting (Monday to Friday). Patients will have a cast applied on Monday morning and worn for 24hrs/day or for 48hrs according to the OTs and treating physician's decision (rationale documented).The OT will decide how many weeks the participant will be wearing casts and the rationale to stop this treatment will be documented. When the treatment is stopped, patients will be encouraged to wear a maintenance splint for the following 2 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Serial casted joint | Experimental | Tailored serial casting intervention following 1 week of usual care Receives: Other: Tailored serial casting intercention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Passive range of motion changes
PROM measures by goniometer (standard and revised goniometry protocol)
Measured: Baseline, Every Monday and Friday of Serial casting intervention weeks (tailored to the patient's needs), 3 weeks post intervention
Active range of motion changes
AROM measures by goniometer (standard and revised goniometry protocol)
Measured: Baseline, Every Monday and Friday of Serial casting intervention weeks (tailored to the patient's needs), 3 weeks post intervention
Secondary outcomes (7)
Patient reported upper-extremity function changes
Short version of The Disabilities of the Arm, Shoulder and Hand questionnaire (QuickDASH); A higher score indicates a greater level of disability and severity, whereas, lower scores indicates a lower level of disability. The score ranges from 0 (no disability) to 100 (most severe disability).
Measured: Baseline, 3 weeks post intervention
Scar patient satisfaction
Patient satisfaction assessment scale (PSAS), A higher score indicates a lower satisfaction towards the scar. The score ranges from 6 (Very satisfied) to60 (Not satisfied at all).
Measured: Baseline, 3 weeks post intervention
Skin Thickness Changes
Ultrasound skin measures, mm
Measured: Baseline, Every Monday and Friday of Serial casting intervention weeks (tailored to the patient's needs), 3 weeks post intervention
Skin Elasticity Changes
Skin elasticity measures (r0- Cutometer), mm
Measured: Baseline, Every Monday and Friday of Serial casting intervention weeks (tailored to the patient's needs), 3 weeks post intervention
Skin Erythema Changes
Erythema index measure by Mexameter, scale values of 0 to 999. The erythema values are individual for each person and depend strongly on the ethnic group. The measurements are generally used to determine changes before and after a treatment.
Measured: Baseline, Every Monday and Friday of Serial casting intervention weeks (tailored to the patient's needs), 3 weeks post intervention
Skin Melanin Changes
Melanin index measured by Mexameter
Measured: Baseline, Every Monday and Friday of Serial casting intervention weeks (tailored to the patient's needs), 3 weeks post intervention
Trans-epidermal water loss (TEWL)
Trans-epidermal water loss (TEWL) measured by Tewameter
Measured: Baseline, Every Monday and Friday of Serial casting intervention weeks (tailored to the patient's needs), 3 weeks post intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jun 2022
- Study start20 Sep 2022
- Primary completion31 Aug 2025
- Study completion20 Sep 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Burn Contracture of SkinStudies of the same condition, open and under way.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre hospitalier de l'Université de Montréal (CHUM)
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Bernadette Nedelec, PhD, Principal investigator, CRCHUM
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05425433
- Sponsor's protocol ID
- 22.084
- Status last verified
- Mar 2026
- First submitted
- 14 Jun 2022
- Last updated
- 20 Mar 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 20 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Should Serial Casting be a "First-resort" Conservative Treatment for Adults With Upper Extremity Burn Contractures?
- ClinicalTrials.gov ID
- NCT05425433
- Acronym / sponsor ID
- 22.084
- Conditions
- Burn Contracture of Skin
- Keywords
- Burns, Burn Rehabilitation, Serial Casting
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- Centre hospitalier de l'Université de Montréal (CHUM)University, hospital or other
- Study start
- 20 Sep 2022 (actual)
- Primary completion
- 31 Aug 2025 (actual)
- Study completion
- 20 Sep 2025 (actual)
- First posted
- 21 Jun 2022 (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.
The use of a splint, serial casting and passive stretching have been described in the literature as conservative interventions to manage joint contractures after burn injury. There is a paucity of literature investigating the effect of serial casting on scar contractures following upper extremity (UE) burn injury in adults and a lack of studies using strong methodological approaches. There are also no studies investigating the effect of casting on hypertrophic scars (HSc) and on self-reported UE function. This study is a longitudinal case series design with a criteria for change on the use of serial casting for the treatment of upper extremity burn contractures. The purpose of this study is to estimate the extent to which range of motion (AROM and PROM), scar characteristics and patient-reported upper-extremity function changes following an individually-tailored serial casting treatment program after switching from one week of usual care and to determine if these changes can be maintained 3 weeks after stopping serial casting, for adult burn survivors who developed an upper-extremity joint contracture greater than 15% normal range of motion within 1-year post-burn. This study will be a longitudinal case series design with a criteria for change. A minimum of 12 participants will be recruited from the "Centre d'expertise pour les victimes de brûlures graves de l'ouest du Québec" (CEVBGOQ) and will undergo one week of "usual care". If the PROM of the joint does not improve after one week of usual care, the participant will start the serial casting process, which will be prescribed by the treating OT. PROM/AROM and scar characteristics will be measured using a revised goniometry protocol that incorporates cutaneokinematics (CKM) principles and precise skin measures (DermaScan C, Cutometer®, Mexameter® and Tewameter®) at baseline, every Monday and Friday of the treatment weeks and 3 weeks after treatment cessation. Self-reported UE function and satisfaction related to scarring will be assessed at baseline and 3 weeks after treatment cessation using the QuickDASH and the patient satisfaction assessment scale (PSAS). Analysis on ROM and scar characteristic will be conducted using a graphical representation with a projected "usual care" regression line to count how many outcomes were over the line once the treatment was introduced. This study will contribute to building evidence for the use of serial casting following UE burn contractures in the adult population.
Detailed description
Participants will undergo a tailored intervention based on their needs.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Serial casted joint | Experimental | Other: Tailored serial casting intercentionTailored serial casting intervention following 1 week of usual care |
Who may qualify
- Ages
- 16 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- Burn survivors with >15% loss of PROM of their PIP, MCP, wrist, or elbow in either: flexion, extension, ulnar deviation or radial deviation.
- Fire, flame or scald burn injury
- -≥16 years old
- have provided informed consent.
Key exclusion criteria (7 listed)
- Frostbite, chemical or electrical burn injury
- A premorbid musculoskeletal or neurological disorder that limited their ROM
- Have sustained a neurological injury secondary to the burn injury
- A psychiatric or cognitive disorder that limits their ability to follow the research protocol
- Have been diagnosed with heterotopic ossification
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 |
|---|---|---|
| Tailored serial casting intercentionEvery participant will undergo 1 week of usual care for the affected joint according to the OT's prescription (static progressive, dynamic or serial static) combined with stretching, moisturizers, pressure therapy, or thermal modalities. After the one week of splinting, if the PROM of the targeted joint does not improve, the participant will start serial casting (Monday to Friday). Patients will have a cast applied on Monday morning and worn for 24hrs/day or for 48hrs according to the OTs and treating physician's decision (rationale documented).The OT will decide how many weeks the participant will be wearing casts and the rationale to stop this treatment will be documented. When the treatment is stopped, patients will be encouraged to wear a maintenance splint for the following 2 weeks. | Other | Serial casted joint |
Primary outcome
Passive range of motion changes
Time frame: Baseline, Every Monday and Friday of Serial casting intervention weeks (tailored to the patient's needs), 3 weeks post intervention
PROM measures by goniometer (standard and revised goniometry protocol)
Active range of motion changes
Time frame: Baseline, Every Monday and Friday of Serial casting intervention weeks (tailored to the patient's needs), 3 weeks post intervention
AROM measures by goniometer (standard and revised goniometry protocol)
7 secondary outcomes
Patient reported upper-extremity function changes
Time frame: Baseline, 3 weeks post intervention
Scar patient satisfaction
Time frame: Baseline, 3 weeks post intervention
Skin Thickness Changes
Time frame: Baseline, Every Monday and Friday of Serial casting intervention weeks (tailored to the patient's needs), 3 weeks post intervention
Skin Elasticity Changes
Time frame: Baseline, Every Monday and Friday of Serial casting intervention weeks (tailored to the patient's needs), 3 weeks post intervention
Skin Erythema Changes
Time frame: Baseline, Every Monday and Friday of Serial casting intervention weeks (tailored to the patient's needs), 3 weeks post intervention
Skin Melanin Changes
Time frame: Baseline, Every Monday and Friday of Serial casting intervention weeks (tailored to the patient's needs), 3 weeks post intervention
Trans-epidermal water loss (TEWL)
Time frame: Baseline, Every Monday and Friday of Serial casting intervention weeks (tailored to the patient's needs), 3 weeks post intervention
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Mar 2026.
- Individual participant dataSharing planned: Undecided
Related trials for Burn Contracture of Skin
Not yet recruitingObservational study
Recurrence of Extremity Joint Contracture After Z-Plasty Versus Full-Thickness Skin Graft
Joint Contracture, Contracture
Recruiting
Autologous Point-of-Care Adipose Therapy: Recent Injury
Burns, Contracture Scar
Recruiting
Autologous Point-of-Care Adipose Therapy: Delayed Injury/Scar
Burns, Contracture Scar
Not yet recruiting
Development and Clinical Study of Burn Wound Nursing Dressing Based on Sodium Hyaluronate Carbomer Composite Hydrogel
Burn, Burn Contracture of Skin
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.
Bernadette Nedelec, PhD principal investigator
CRCHUM
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Tailored serial casting intercention in people with Burn Contracture of Skin, run by Centre hospitalier de l'Université de Montréal (CHUM) at 1 site in Canada.
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 4 inclusion and 7 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: finished, as of the sponsor's last update on 20 Mar 2026. 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 Canada. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Passive range of motion changes (time frame: Baseline, Every Monday and Friday of Serial casting intervention weeks (tailored to the patient's needs), 3 weeks post intervention). 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 20 Mar 2026.