BurnsEXTREMANCT04132180
Early Versus Late Upper Extremity Mobilization After Autograft
A study testing Early Mobilization and Late Mobilization in people with Burns, run by Sunnybrook Health Sciences Centre at 1 site in Canada.
Trial summary
Rationale: There is currently no observational study or randomized clinical trial published evaluating the impact of early versus late mobilization in the upper extremity after split thickness skin autograft. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Burns
- What is being tested?
- Early Mobilization and Late Mobilization
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2 participants
- Where
- 1 siteCanada
- Study dates
- 14 Aug 2018to 10 Feb 2022
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 18 years and older at the time of surgery.
- Injury: Acute (within 72h of injury) thermal flame or scald burn.
- Surgery: Skin split-thickness meshed autograft (STSG) applied directly on the wound bed.
- Location: Upper extremity burn - distal to the axilla and proximal to the wrist.
Who cannot join
- Injury: Electrical and chemical burn.
- Location: Autograft exclusively to the wrist, hand, axilla or non-upper extremity.
- Patients on vasopressors the day of the operation.
- Pre-existing comorbidities causing upper extremity mobility restrictions.
- Patient unable to comply with mobilization protocol.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The EXTREMA Trial: The Impact of Early Versus Late Upper Extremity Mobilization After Split Thickness Skin Autograft on Wound Healing in Adult Burn Patients - A Single Center Non-Inferiority Randomized Clinical Trial
Rationale: There is currently no observational study or randomized clinical trial published evaluating the impact of early versus late mobilization in the upper extremity after split thickness skin autograft. As the current post-operative care protocols vary based on physician preference, evidence is needed to optimize post-operative rehabilitation protocols guided by evidence which optimize wound healing, extremity range of motion, graft site pain, as well as minimize risks of complications and length of stay in hospital.
Objective: To determine if early mobilization is non-inferior to late mobilization of the upper extremity after split thickness skin autograft with regards to wound healing measured as percent graft take on post-operative day 5 in adult burn patients.
- Conditions
- Burns
- Being tested
- Early Mobilization, Late Mobilization
- Medical subject headings
- Burns
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Early MobilizationOther
Range of motion exercises of the upper extremity will be performed under the guidance of the physical therapy team starting on post-operative day 1.
Late MobilizationOther
The patient's grafted upper extremity will be immobilized using an elbow flexion blocking splint until post-operative day 5.
| Study group | Role | What they receive |
|---|---|---|
| Early mobilization | Experimental | Not described Receives: Other: Early Mobilization |
| Late mobilization | Active comparator | Not described Receives: Other: Late Mobilization |
What is being measured
The primary outcome is the main question the study is designed to answer.
Wound healing
Percent graft take
Measured: Post-operative day 5
Secondary outcomes (7)
Wound healing
Percent graft take
Measured: Post-operative day 14
Post-operative clinical outcomes
Elbow range of motion measured using a goniometer.
Measured: Post-operative day 5 and 14
Post-operative clinical outcomes
Graft site pain measured using visual analogue scale (0 - no pain to 10 - worst possible pain)
Measured: Post-operative day 5 and 14
Post-operative complications
Local complications (seroma, hematoma, infection, graft loss) and systemic complications (infection, deep vein thrombosis, pulmonary embolism, myocardial infarction, mortality).
Measured: Acute hospital stay, up to one year
Discharge outcome - disposition
Discharge disposition
Measured: Acute hospital stay, up to one year
Discharge outcome - readiness
Timing of readiness for discharge.
Measured: Acute hospital stay, up to one year
Discharge outcome - length of stay
Length of stay in hospital. From date of admission to date of discharge.
Measured: Acute hospital stay, up to one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Oct 2019
- Study start14 Aug 2018
- Primary completion10 Feb 2022
- Study completion10 Feb 2022
Why it stopped: Slow recruitment.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for BurnsStudies of the same condition, open and under way.
- More trials run by Sunnybrook Health Sciences CentreThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 2 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sunnybrook Health Sciences Centre
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr. Shahriar Shahrokhi, Sunnybrook Health Sciences Centre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04132180
- Sponsor's protocol ID
- 009-2018
- Acronym
- EXTREMA
- Status last verified
- Feb 2022
- First submitted
- 20 Sep 2018
- Last updated
- 2 Mar 2022
- 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 2 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The EXTREMA Trial: The Impact of Early Versus Late Upper Extremity Mobilization After Split Thickness Skin Autograft on Wound Healing in Adult Burn Patients - A Single Center Non-Inferiority Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT04132180
- Acronym / sponsor ID
- EXTREMA / 009-2018
- Conditions
- Burns
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Slow recruitment.
- Enrolment
- 2 participants (actual)
- Lead sponsor
- Sunnybrook Health Sciences CentreUniversity, hospital or other
- Study start
- 14 Aug 2018 (actual)
- Primary completion
- 10 Feb 2022 (actual)
- Study completion
- 10 Feb 2022 (actual)
- First posted
- 18 Oct 2019 (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.
Rationale: There is currently no observational study or randomized clinical trial published evaluating the impact of early versus late mobilization in the upper extremity after split thickness skin autograft. As the current post-operative care protocols vary based on physician preference, evidence is needed to optimize post-operative rehabilitation protocols guided by evidence which optimize wound healing, extremity range of motion, graft site pain, as well as minimize risks of complications and length of stay in hospital.
Objective: To determine if early mobilization is non-inferior to late mobilization of the upper extremity after split thickness skin autograft with regards to wound healing measured as percent graft take on post-operative day 5 in adult burn patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Early mobilization | Experimental | Other: Early Mobilization |
| Late mobilization | Active comparator | Other: Late Mobilization |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 18 years and older at the time of surgery.
- Injury: Acute (within 72h of injury) thermal flame or scald burn.
- Surgery: Skin split-thickness meshed autograft (STSG) applied directly on the wound bed.
- Location: Upper extremity burn - distal to the axilla and proximal to the wrist.
Key exclusion criteria (5 listed)
- Injury: Electrical and chemical burn.
- Location: Autograft exclusively to the wrist, hand, axilla or non-upper extremity.
- Patients on vasopressors the day of the operation.
- Pre-existing comorbidities causing upper extremity mobility restrictions.
- Patient unable to comply with mobilization protocol.
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 |
|---|---|---|
| Early MobilizationRange of motion exercises of the upper extremity will be performed under the guidance of the physical therapy team starting on post-operative day 1. | Other | Early mobilization |
| Late MobilizationThe patient's grafted upper extremity will be immobilized using an elbow flexion blocking splint until post-operative day 5. | Other | Late mobilization |
Primary outcome
Wound healing
Time frame: Post-operative day 5
Percent graft take
7 secondary outcomes
Wound healing
Time frame: Post-operative day 14
Post-operative clinical outcomes
Time frame: Post-operative day 5 and 14
Post-operative clinical outcomes
Time frame: Post-operative day 5 and 14
Post-operative complications
Time frame: Acute hospital stay, up to one year
Discharge outcome - disposition
Time frame: Acute hospital stay, up to one year
Discharge outcome - readiness
Time frame: Acute hospital stay, up to one year
Discharge outcome - length of stay
Time frame: Acute hospital stay, up to one year
Results and safety
The study was stopped early (reason given: Slow recruitment.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Mar 2022.
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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?
A study testing Early Mobilization and Late Mobilization in people with Burns, run by Sunnybrook Health Sciences Centre 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 5 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: stopped early, as of the sponsor's last update on 2 Mar 2022. 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 was stopped early (reason given: Slow recruitment.). 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?
Wound healing (time frame: Post-operative day 5). 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 2 Mar 2022; AzTrials last refreshed its copy on 6 Nov 2026.