[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100658223":3},{"organization":4,"outcomesModule":7,"designInfo":22,"detailedDescription":25,"studyPopulation":26,"armGroups":27,"interventions":34,"overallOfficials":21,"centralContacts":43,"locations":49,"responsibleParty":66,"collaborators":68,"id":71,"slug":72,"hasResults":73,"nctId":74,"briefTitle":75,"officialTitle":76,"acronym":21,"eligibilityCriteria":77,"healthyVolunteers":73,"sex":78,"minAge":79,"maxAge":21,"enrollmentInfo":80,"targetDuration":21,"studyType":83,"phases":21,"briefSummary":84,"conditions":85,"keywords":90,"overallStatus":96,"whyStopped":21,"lastUpdateSubmitDate":97,"lastUpdatePostDateStruct":98,"startDateStruct":101,"completionDateStruct":103,"leadSponsor":105,"locationsCount":106},{"fullName":5,"class":6},"Centre hospitalier de l'Université de Montréal (CHUM)","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":21},[9],{"measure":10,"description":11,"timeFrame":12},"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)",[14,18],{"measure":15,"description":16,"timeFrame":17},"Feasibility outcomes","Determine procedural feasibility and inform the design of a future powered study. - Recruitment rate\n\n* Completion rate\n* Proportion of usable pressure recordings\n* Time required for full assessment per participant\n* Sensor placement success rate\n* Incidence of adverse events","across all participants data collection period (three years)",{"measure":19,"description":20,"timeFrame":12},"Association Between Skin Characteristics and Interface Pressure","Associations between:\n\n* Skin thickness\n* Elasticity\n* Transepidermal water loss\n* Melanin and erythema indices\n* Mean and peak interface pressure values",null,{"allocation":21,"interventionModel":21,"interventionModelDescription":21,"primaryPurpose":21,"observationalModel":23,"timePerspective":24,"maskingInfo":21},"CASE_ONLY","PROSPECTIVE","Amputation following burn injury is uncommon. Major amputations following burn injury differ substantially from those performed in diabetic or vascular populations: burn-injured amputees are generally healthier, residual limb segments are longer, muscle flaps create bulkier stumps, and the residual limbs often present with hypertrophic scarring and contractures.\n\nHowever, multiple complications may develop in individuals with burn-related amputations, including residual limb pain, edema, sensory disturbances (hypo- or hypersensitivity), heterotopic ossification, and recurrent wounds.\n\nPressure therapy has been widely used in burn rehabilitation to treat hypertrophic scars. It is believed to promote scar maturation by reducing mechanical tension. However, no studies to date have quantified the pressures exerted on hypertrophic scars of amputees with burn injuries when wearing their prosthetic liner or full prosthesis. This knowledge gap is critical, as pressures exceeding 40 mmHg can compromise capillary perfusion and cause pain, blistering, or tissue necrosis, which are risks that are exacerbated in grafted or flapped tissues predisposing them to skin breakdown.\n\nStudies conducted in non-burn amputee populations have demonstrated that pressure distribution within a prosthetic socket varies significantly depending on socket design and materials. Reported interface pressures typically range from 40 kPa to 250 kPa (approximately 300-1875 mmHg). Measurement conditions also influence results, as pressures differ during static standing compared with dynamic gait. Liner thickness further affects these values; for example, increasing liner thickness by 4 mm has been shown to reduce peak pressures by approximately 18%. These findings highlight the importance of assessing pressure under realistic conditions, with the complete prosthetic system in place.\n\nClinically, it is often observed that hypertrophic scars covered by a prosthesis tend to flatten, become less erythematous, and appear more mature than adjacent uncovered scars. This observation led to the current research question and the hypothesis that prosthetic-induced pressure exceeds the pressure that is generated by standard pressure garments. Furthermore, it raises the question of whether residual limb wounds in this population may result from localized peak pressures within the prosthetic socket.\n\nThe objective of this pilot study is to improve understanding of prosthesis-residual limb interactions in burn-injured amputees and to assess the feasibility of measuring these interactions using objective pressure assessment tools.\n\nThis study is a prospective, minimal-risk, pilot observational feasibility study using a repeated-measures design. The study involves non-invasive interface pressure measurements obtained under usual prosthetic use conditions in adults with burn-related amputations. No therapeutic intervention or modification to standard clinical care will be introduced. The primary objective is to quantify prosthesis-induced interface pressures at predefined residual limb sites. The secondary objectives are to evaluate the feasibility, reliability, and acceptability of pressure measurement tools in this specific clinical population.","Adult burn survivors with a major limb amputation who are admitted to or followed in the outpatient clinic at Villa Medica Rehabilitation Centre",[28],{"label":29,"type":21,"description":30,"interventionNames":31},"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.",[32,33],"Other: Skin assessment of prothesis interface and control area","Other: Interface pressure",[35,39],{"type":6,"name":36,"description":37,"armGroupLabels":38,"otherNames":21},"Skin assessment of prothesis interface and control area","Evaluation of Melamin and erythema (Mexameter), TEWL ( Tewameter), skin elasticity (Cutometer), skin thickness (Dermascan)",[29],{"type":6,"name":40,"description":41,"armGroupLabels":42,"otherNames":21},"Interface pressure","Mean and peak interface pressure (limb to prosthetic)",[29],[44],{"name":45,"role":46,"phone":47,"phoneExt":21,"email":48},"Bernadette Nedelec, phD","CONTACT","5143981275","bernadette.nedelec@mcgill.ca",[50],{"facility":51,"status":21,"city":52,"state":53,"zip":54,"country":55,"countryCode":56,"cosmosGeoPoint":57,"geoPoint":62,"contacts":63},"Villa Medica Rehabilitation Centre","Montreal","Quebec","H3G1Y5","Canada","CA",{"type":58,"coordinates":59},"Point",[60,61],-73.58781,45.50884,{"lat":61,"lon":60},[64],{"name":65,"role":46,"phone":47,"phoneExt":21,"email":48},"Bernadette Nedelec, PhD",{"type":67,"investigatorFullName":21,"investigatorTitle":21,"investigatorAffiliation":21,"oldNameTitle":21,"oldOrganization":21},"SPONSOR",[69],{"name":70,"class":6},"Quebec Firefighters Foundation for Burns","100658223","hypertrophic-scar-prosthetic-pressure-in-burn-amputee-100658223",false,"NCT07850557","Hypertrophic Scar Prosthetic Pressure in Burn Amputee","Hypertrophic Scar Prosthetic Pressure in Burn Amputee: A Pilot Study","Inclusion Criteria:\n\n* 1\\. Burn survivors aged 16 years and older who have sustained a major amputation secondary to a burn injury.\n\n  2\\. 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\u002For foot).\n\n  3\\. Participants must be proficient in English and\u002For French and capable of providing informed consent\n\nExclusion Criteria:\n\n* present dermatological conditions that may compromise measurement reliability (e.g., eczema, psoriasis).\n* Participants with cognitive or psychiatric conditions that could impair comprehension of the consent process or adherence to study procedures will also be excluded","ALL","16 Years",{"count":81,"type":82},12,"ESTIMATED","OBSERVATIONAL","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.",[86,87,88,89],"Amputation Stump","Burn Injury","Pressure Distribution","Pressure Injuries",[91,92,93,94,95],"Prosthetic","Pressure","Hypertrophic scar","burn injuries","amputee","NOT_YET_RECRUITING","2026-09-24",{"date":99,"type":100},"2026-09-30","ACTUAL",{"date":102,"type":82},"2026-09-01",{"date":104,"type":82},"2026-12-31",{"name":5,"class":6},1]