Hypertrophic Scar Prosthetic Pressure in Burn Amputee

NCT07850557 | Not Yet Recruiting

• 1 other identifier: 2027-13830
• Study Type: observational
• Target: 12
• Locations: 1 country
• Sites: 1

Brief Summary

Amputation following burn injury is rare but complex, affecting predominantly younger individuals with extensive burns, particularly electrical injuries, and often resulting in residual limbs characterized by scarring, contractures, grafted or flapped tissues, and heightened vulnerability to skin breakdown. Prosthesis-covered burn scars often appear to heal better than uncovered areas, suggesting a potential therapeutic pressure effect; however, excessive localized peak pressures may also contribute to recurrent wounds in grafted or scarred tissues. This study aims to quantify prosthesis-induced pressures on the residual limbs of burn-injured amputees and evaluate the feasibility and reliability of applying pressure measurement tools validated in burn care to this distinct clinical context.

Conditions

Amputation Stump; Burn Injury; Pressure Distribution; Pressure Injuries

Keywords

Prosthetic; Pressure; Hypertrophic scar; burn injuries; amputee

Outcome Measures

Primary Outcomes (1)

• Prosthetic-induced interface pressure

  quantification of interface pressure (mmHg) at predefined residual limb sites in burn-related amputees, assessing within-subject differences in interface pressure

  From enrollment to end of visit (2 hours)

Secondary Outcomes (2)

• Feasibility outcomes

  across all participants data collection period (three years)

• Association Between Skin Characteristics and Interface Pressure

  From enrollment to end of visit (2 hours)

Study Arms (1)

Prostheses wearer

Person must have a amputated stump with a prothese, caused by burn injuries. The evaluated zone can include hypertrophic scar (HSc) sites, flaps, wounds, areas of localized pain, the distal residuum, bony prominences, and soft tissue regions in prosthetic interface. The control zone is a normal skin area of the same person.

Other: Skin assessment of prothesis interface and control area; Other: Interface pressure

Interventions

Skin assessment of prothesis interface and control area OTHER

Evaluation of Melamin and erythema (Mexameter), TEWL ( Tewameter), skin elasticity (Cutometer), skin thickness (Dermascan)

Prostheses wearer

Interface pressure OTHER

Mean and peak interface pressure (limb to prosthetic)

Prostheses wearer

Eligibility Criteria

• Age: 16 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Adult burn survivors with a major limb amputation who are admitted to or followed in the outpatient clinic at Villa Medica Rehabilitation Centre

You may qualify if:

• \. Burn survivors aged 16 years and older who have sustained a major amputation secondary to a burn injury.
• \. Participants must be fitted with a definitive prosthesis incorporating a socket (laminate- or carbon-based) and have received their final prosthetic components (e.g., prosthetic knee and/or foot).
• \. Participants must be proficient in English and/or French and capable of providing informed consent

You may not qualify if:

• present dermatological conditions that may compromise measurement reliability (e.g., eczema, psoriasis).
• Participants with cognitive or psychiatric conditions that could impair comprehension of the consent process or adherence to study procedures will also be excluded

Sponsors & Collaborators

• Centre hospitalier de l'Université de Montréal (CHUM): lead
• Quebec Firefighters Foundation for Burns: collaborator

Study Sites (1)

Villa Medica Rehabilitation Centre

Montreal, Quebec, H3G1Y5, Canada

Location

MeSH Terms

Conditions

Burns; Pressure Ulcer; Cicatrix, Hypertrophic

Condition Hierarchy (Ancestors)

Wounds and Injuries; Skin Ulcer; Skin Diseases; Skin and Connective Tissue Diseases; Cicatrix; Fibrosis; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Bernadette Nedelec, phD

CONTACT

5143981275; bernadette.nedelec@mcgill.ca

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 18, 2026
• First Posted: September 30, 2026
• Study Start: September 1, 2026
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: September 30, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)