Health TrialsbyHealthPanel

Hypertrophic Scar Prosthetic Pressure in Burn Amputee

ConditionsAmputation StumpBurn InjuryPressure DistributionPressure Injuries
Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age16+
SponsorCentre hospitalier de l'Université de Montréal (CHUM)

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

1. Burn survivors aged 16 years and older who have sustained a major amputation secondary to a burn injury.

Disqualifiers

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

Trial population

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

Trial design

Design model

Case-only

Time perspective

Prospective

Treatments tested in this trial

  • Skin assessment of prothesis interface and control area

    Other intervention

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

  • Interface pressure

    Other intervention

    Mean and peak interface pressure (limb to prosthetic)

Treatment groups

12 Participants
are divided into 1 treatment group
Group A: Prostheses wearer2 interventions

Trial outcomes

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

Time frame
From enrollment to end of visit (2 hours)

Secondary outcomes

1

Feasibility outcomes

Determine procedural feasibility and inform the design of a future powered study. - Recruitment rate * Completion rate * Proportion of usable pressure recordings * Time required for full assessment per participant * Sensor placement success rate * Incidence of adverse events

Time frame
across all participants data collection period (three years)
2

Association Between Skin Characteristics and Interface Pressure

Associations between: * Skin thickness * Elasticity * Transepidermal water loss * Melanin and erythema indices * Mean and peak interface pressure values

Time frame
From enrollment to end of visit (2 hours)

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Centre hospitalier de l'Université de Montréal (CHUM)

Lead sponsor

Quebec Firefighters Foundation for Burns

Collaborator

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: