Clincosm LogoSign in Get a demo

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

Sponsor
Université de Sherbrooke (Other)
Overall Status
Recruiting
CT.gov ID
NCT03593174
Collaborator
(none)
10
Enrollment
1
Location
2
Arms
30.4
Anticipated Duration (Months)
0.3
Patients Per Site Per Month

Study Details

Study Description

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).

Condition or Disease Intervention/Treatment Phase
  • Device: Ossur Rigid Dressing
  • Device: Elastic Bandage
 N/A

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 Design

Study Type:
Interventional
Anticipated Enrollment :
10 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Étude de l'efficacité du Pansement Rigide Amovible Sous Vide à Titre de modalité de Pansement Post-amputation Tibiale
Actual Study Start Date :
Nov 19, 2019
Anticipated Primary Completion Date :
Jan 1, 2022
Anticipated Study Completion Date :
Jun 1, 2022

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

  1. Stump size [8 weeks]

    Leg circumference measure

Eligibility Criteria

Criteria

Ages Eligible for Study:
40 Years to 75 Years
Sexes Eligible for Study:
All
Accepts 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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Université de Sherbrooke Sherbrooke Quebec Canada J1K 2R1

Sponsors and Collaborators

  • Université de Sherbrooke

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Université de Sherbrooke
ClinicalTrials.gov Identifier:
NCT03593174
Other Study ID Numbers:
  • 2018-2617
First Posted:
Jul 19, 2018
Last Update Posted:
Sep 29, 2021
Last Verified:
Sep 1, 2021
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Université de Sherbrooke
Amputation

Study Results

No Results Posted as of Sep 29, 2021