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

September 27, 2021 updated by: Université de Sherbrooke
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).

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

10

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Canada
    • Quebec
      • Sherbrooke, Quebec, Canada, J1K 2R1
        • Recruiting
        • Université de Sherbrooke
        • Contact:
          • Michel Tousignant, PhD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

40 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Ossur Rigid Dressing
Use of ORD, which is a type of Removable Rigid Dressing (RRD), as a post tibial amputation dressing modality.
Device: Ossur Rigid Dressing
Removable Rigid Dressing
Active Comparator: Elastic bandage
Use of the elastic bandage as a post amputation dressing modality.
Device: Elastic Bandage
Usual modality: Elastic bandage

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Stump size
Time Frame: 8 weeks
Leg circumference measure
8 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Université de Sherbrooke

Investigators

  • Study Director: Michel Tousignant, Phd, Université de Sherbrooke

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 19, 2019

Primary Completion (Anticipated)

January 1, 2022

Study Completion (Anticipated)

June 1, 2022

Study Registration Dates

First Submitted

June 19, 2018

First Submitted That Met QC Criteria

July 18, 2018

First Posted (Actual)

July 19, 2018

Study Record Updates

Last Update Posted (Actual)

September 29, 2021

Last Update Submitted That Met QC Criteria

September 27, 2021

Last Verified

September 1, 2021

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 2018-2617

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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