NCT03593174

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

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 10 (estimated)
• Sponsor: Université de Sherbrooke · Academic / Other
• Sex: All
• Age: 40 Years – 75 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Trans-tibial Amputations

Interventions

Type	Name	Description
DEVICE	Ossur Rigid Dressing	Removable Rigid Dressing
DEVICE	Elastic Bandage	Usual modality: Elastic bandage

Timeline

• Start date: 2019-11-19
• Primary completion: 2022-01-01
• Completion: 2022-06-01
• First posted: 2018-07-19
• Last updated: 2021-09-29

Locations

1 site across 1 country: Canada