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Serial Casting for Burns Contracture

N/A
Recruiting
Led By Bernadette Nedelec, PhD
Research Sponsored by Centre hospitalier de l'Université de Montréal (CHUM)
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
≥16 years old
Burn survivors with >15% loss of PROM of their PIP, MCP, wrist, or elbow in either: flexion, extension, ulnar deviation or radial deviation
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline, 3 weeks post intervention
Awards & highlights

Study Summary

This trial is investigating the effect of serial casting on scar contractures, range of motion, and self-reported function in adults with upper extremity burn injuries.

Who is the study for?
This trial is for adult burn survivors who have lost more than 15% of their normal range of motion in joints like fingers, wrists, or elbows due to fire, flame, or scald burns. They must understand English or French and be able to follow the study's procedures. People with frostbite, chemical/electrical burns, certain psychiatric/cognitive disorders, neurological injuries from the burn, pre-existing conditions affecting movement, heterotopic ossification or when stretching is not advised cannot join.Check my eligibility
What is being tested?
The trial tests a tailored serial casting treatment on adults with upper extremity burn contractures. It compares one week of usual care followed by serial casting if there's no improvement in joint movement. The effects on scar characteristics and self-reported arm function are measured over time and compared against expected outcomes without this intervention.See study design
What are the potential side effects?
While specific side effects are not listed for this conservative treatment approach involving splints and casts designed to improve mobility after burns; potential discomforts may include skin irritation under the cast and temporary stiffness during adjustment periods.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am 16 years old or older.
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I am a burn survivor with significant movement loss in my hand or arm.
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I have had a burn injury caused by fire, flame, or scalding.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline, 3 weeks post intervention
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline, 3 weeks post intervention for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Active range of motion changes
Passive range of motion changes
Secondary outcome measures
Patient reported upper-extremity function changes
Scar patient satisfaction
Skin Elasticity Changes
+4 more

Trial Design

1Treatment groups
Experimental Treatment
Group I: Serial casted jointExperimental Treatment1 Intervention
Tailored serial casting intervention following 1 week of usual care

Find a Location

Who is running the clinical trial?

Centre hospitalier de l'Université de Montréal (CHUM)Lead Sponsor
365 Previous Clinical Trials
129,297 Total Patients Enrolled
Bernadette Nedelec, PhDPrincipal InvestigatorCRCHUM
2 Previous Clinical Trials
60 Total Patients Enrolled

Media Library

Tailored serial casting intervention Clinical Trial Eligibility Overview. Trial Name: NCT05425433 — N/A
Burns Contracture Research Study Groups: Serial casted joint
Burns Contracture Clinical Trial 2023: Tailored serial casting intervention Highlights & Side Effects. Trial Name: NCT05425433 — N/A
Tailored serial casting intervention 2023 Treatment Timeline for Medical Study. Trial Name: NCT05425433 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Does the eligibility criteria for this clinical trial extend to those over 35 years of age?

"The lower limit for enrollment in this clinical trial is 16 years of age and the upper bound is 100."

Answered by AI

Who is most suitable to join in this experiment?

"To be enrolled in this trial, individuals need to have sustained a burn injury and meet the age criteria of 16-100. The researchers are searching for precisely 12 participants."

Answered by AI

What major goals has this research endeavor set out to achieve?

"This research trial aims to monitor Active range of motion changes over a Baseline, Every Monday and Friday of Serial casting intervention weeks (tailored to the patient's needs), 3 weeks post-intervention timeline. Secondary outcomes encompass Scar patient satisfaction assessed via Patient Satisfaction Assessment Scale (PSAS) with ratings from 6 (Very satisfied) to 60 (Not satisfied at all). Additionally, Upper-Extremity Function Changes will be monitored utilizing the Short version of The Disabilities of the Arm, Shoulder and Hand questionnaire (QuickDASH); scores ranging from 0 (no disability) to 100(most severe disability). Finally, Skin Elastic"

Answered by AI

Is recruitment for this trialing still ongoing?

"Affirmative. Clinicaltrials.gov details the recruitment status of this clinical trial, which was posted on September 20th 2022 and last modified on November 11th 2022. The research team is seeking 12 participants from two different medical centres."

Answered by AI

What is the maximum amount of participants that can join this medical trial?

"Affirmative. The clinicaltrials.gov page for this study indicates that it is actively recruiting patients, with the original posting taking place on September 20th 2022 and most recent edit occurring November 11th of the same year. 12 individuals are being sought at 2 trial sites."

Answered by AI
~2 spots leftby Sep 2024