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Étude de l'efficacité du Pansement Rigide Amovible Sous Vide à Titre de modalité de Pansement Post-amputation Tibiale

Étude de l'efficacité du Pansement Rigide Amovible Sous Vide à Titre de modalité de Pansement Post-amputation Tibiale

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03593174
Enrollment
10
Registered
2018-07-19
Start date
2019-11-19
Completion date
2022-06-30
Last updated
2021-09-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Trans-tibial Amputations

Keywords

Amputation

Brief summary

The present study will measure the efficiency of a new modality for trans-tibial amputations in Quebec's health system, to reduce the time before prosthesis fitting, compared to the usual modality. The present study will evaluate the feasability of implantation of this new modality in Quebec and demonstrate its superiority in comparison to the usual modality (shorter time before fitting and reduction of costs).

Detailed description

The main objective of the present study is to obtain an estimation of the efficiency of a Removable Rigid Dressing (RRD) -type compression modality immediately following a tibial amputation as an alternative to the elastic bandage, which is the usually-used modality. This pilot study will verify the feasability of implantation of this type of dressing, and to collect data on the main dependant variables of this research projet in order to eventually estimate the expected effect on a larger population. The main objectives of this study are: 1. To explore the efficacy of the RRD in comparison to the elastic bandage on the size of the stump, associated complications and necessary time to fitting of the prosthesis. 2. Verify the facilitators and obstacles to implantation of the RRD as a post tibial ambutation dressing modality as an alternative to the elastic bandage.

Interventions

DEVICEOssur Rigid Dressing

Removable Rigid Dressing

Usual modality: Elastic bandage

Sponsors

Université de Sherbrooke
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
40 Years to 75 Years
Healthy volunteers
No

Inclusion criteria

* Need of a trans-tibial amputation of atraumatic cause * Between 40 and 75 years of age

Exclusion criteria

\- Having a medical condition that could significantly affect the healing process

Design outcomes

Primary

MeasureTime frameDescription
Stump size8 weeksLeg circumference measure

Countries

Canada

Contacts

Primary ContactMichel Tousignant, Phd
Michel.Tousignant@USherbrooke.ca819-821-8000

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026