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

NCT ID: NCT03593174

Last Updated: 2021-09-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

10 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-11-19

Study Completion Date

2022-06-30

Brief Summary

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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

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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

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Trans-tibial Amputations

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Ossur Rigid Dressing

Use of ORD, which is a type of Removable Rigid Dressing (RRD), as a post tibial amputation dressing modality.

Group Type EXPERIMENTAL

Ossur Rigid Dressing

Intervention Type DEVICE

Removable Rigid Dressing

Elastic bandage

Use of the elastic bandage as a post amputation dressing modality.

Group Type ACTIVE_COMPARATOR

Elastic Bandage

Intervention Type DEVICE

Usual modality: Elastic bandage

Interventions

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Ossur Rigid Dressing

Removable Rigid Dressing

Intervention Type DEVICE

Elastic Bandage

Usual modality: Elastic bandage

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

40 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Université de Sherbrooke

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Michel Tousignant, Phd

Role: STUDY_DIRECTOR

Université de Sherbrooke

Locations

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Université de Sherbrooke

Sherbrooke, Quebec, Canada

Site Status RECRUITING

Countries

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Canada

Central Contacts

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Michel Tousignant, Phd

Role: CONTACT

819-821-8000 ext. 72900

Facility Contacts

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Michel Tousignant, PhD

Role: primary

Other Identifiers

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2018-2617

Identifier Type: -

Identifier Source: org_study_id

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