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

Trans-tibial Amputations Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03593174
• Other study ID #: 2018-2617
• Status: Recruiting
• Phase: N/A
• Start date: November 19, 2019
• Est. completion date: June 2022

Study information

• Verified date: September 2021
• Source: Université de Sherbrooke
• Contact: Michel Tousignant, Phd
• Phone: 819-821-8000
• Email: Michel.Tousignant[@]USherbrooke.ca
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 10
• Est. completion date: June 2022
• Est. primary completion date: January 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Trans-tibial Amputations

Intervention

Device:
• Ossur Rigid Dressing
Removable Rigid Dressing
• Elastic Bandage
Usual modality: Elastic bandage

Locations

Country	Name	City	State
Canada	Université de Sherbrooke	Sherbrooke	Quebec

Sponsors (1)

Lead Sponsor	Collaborator
Université de Sherbrooke

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Stump size	Leg circumference measure	8 weeks