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

Université de Sherbrooke

Status: Unknown

Conditions: Trans-tibial Amputations

Treatments: Device: Elastic Bandage; Device: Ossur Rigid Dressing

Study type: Interventional

Funder types: Other

Identifiers

NCT03593174

2018-2617

Details and patient eligibility

About

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).

Full 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.

Enrollment: 10 estimated patients

Sex: All

Ages: 40 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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10 participants in 2 patient groups

Ossur Rigid Dressing

Experimental group

Description:

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

Treatment:

Device: Ossur Rigid Dressing

Elastic bandage

Active Comparator group

Description:

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

Treatment:

Device: Elastic Bandage