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

Not Applicable

• Conditions: Trans-tibial Amputations
• Interventions: Device: Elastic Bandage; Device: Ossur Rigid Dressing

• Registration Number: NCT03593174
• Lead Sponsor: Université de Sherbrooke

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.

Study Timeline

• Study First Submitted: 2018-06-19
• Study First Submitted QC: 2018-07-18
• Study First Posted: 2018-07-19
• Study Start: 2019-11-19
• Status Verified: 2021-09
• Last Update Submitted: 2021-09-27
• Last Update Posted: 2021-09-29
• Primary Completion: 2022-01
• Study Completion: 2022-06

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 10

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Elastic bandage	Elastic Bandage	Use of the elastic bandage as a post amputation dressing modality.
Ossur Rigid Dressing	Ossur Rigid Dressing	Use of ORD, which is a type of Removable Rigid Dressing (RRD), as a post tibial amputation dressing modality.

Primary Outcome Measures

Name	Time	Method
Stump size	8 weeks	Leg circumference measure

Trial Locations

Locations (1)

Université de Sherbrooke; 🇨🇦 Sherbrooke, Quebec, Canada