Comparison Between Postoperative Tubular Dressing and a Vacuum Removable Rigid Dressing After Transtibial Amputation (EMPAR)
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|ClinicalTrials.gov Identifier: NCT03948087|
Recruitment Status : Not yet recruiting
First Posted : May 13, 2019
Last Update Posted : May 13, 2019
|Condition or disease||Intervention/treatment||Phase|
|Amputation Stump Peripheral Vascular Disease With Complications Edema Leg Wound Healing Delayed||Device: Vacuum Removable Rigid Dressing (VRRD)||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||100 participants|
|Intervention Model:||Parallel Assignment|
|Intervention Model Description:||Participants will be randomly assigned to an interventional group (vacuum rigid removable dressing) vs a non-interventional group (standard of care control group of soft dressing application).|
|Masking:||Single (Outcomes Assessor)|
|Masking Description:||Wound assessments will be determined in a blinded capacity by utilizing the Photographic Wound Assessment Tool. Photos of individual study participant's wounds will be taken and then assigned a non-identifying marker prior to being submitted by the wound assessor.|
|Official Title:||Comparison of Wound Healing, Edema Level, Knee Range of Motion, Protection Post Falls, Device Application, Time to Prosthetic Fit, and Cost Between Postoperative Soft Dressing and Vacuum Removable Rigid Dressing After Transtibial Amputation|
|Estimated Study Start Date :||May 2019|
|Estimated Primary Completion Date :||October 2020|
|Estimated Study Completion Date :||May 2021|
Experimental: Vacuum Removable Rigid Dressing (VRRD)
Application of a Vacuum Removable Rigid Dressing (VRRD)
Device: Vacuum Removable Rigid Dressing (VRRD)
Intra-operative application of device.
Other Name: Ossur (TM) Rigid Dressing (ORD)
No Intervention: Soft Dressing Control Group
Application of standard of care soft dressing (SD) intra-operatively.
- Evaluation of Change in Stump Wound Healing [ Time Frame: Day 3,7,14,30,48 ]The Photographic Wound Assessment Tool (PWAT) will be used in a blinded fashion to evaluate the level of change in wound healing of the transtibial amputation primary closure. The PWAT incorporates type and amount of necrotic tissue, wound edge definition, surrounding skin color, epithelialization, and granulation of tissue. A score of 0/24 on the PWAT indicates complete wound closure.
- Evaluation of Change in Level of Limb Edema [ Time Frame: Day 3,7,14,30,48 ]Circumferential measurements will be taken at two levels of the residual stump. Centimeters measured circumferentially at 5 cm from the distal end and around the knee at the center of the patella
- Evaluation of Change in Knee Range of Motion [ Time Frame: Day 3,7,14,30,48 ]Degrees measured via goniometry into knee flexion and extension for both active and passive range of motion.
- Rate of Revision Post Falls [ Time Frame: Until prosthetic limb fit, on average 2 months. ]Falls sustained by study participants will be recorded. Whether a follow-up revision surgery was necessary will also be recorded.
- Total Amount of Time to Apply, Change, Clean and Alter the Dressings [ Time Frame: Until discharge from acute care, on average 2 weeks. ]Time log in minutes recorded by staff in real time providing care to study participants.
- Length of time Until the Residual Limb is Ready for Prosthetic Fitting [ Time Frame: Through study completion, on average 2 months. ]Time log in days beginning post operative day 1 until the study participant is fit with a definitive prosthetic limb.
- Total Length of Stay in Acute and Sub-acute Care Facilities [ Time Frame: Through study completion, on average 3 weeks. ]A time log in days of how long a given study participant is admitted to an acute or sub-acute care facility.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03948087
|Contact: Amputee Coordinatorfirstname.lastname@example.org|
|Principal Investigator:||Trent I Duchscherer, MSc||Amputee Coordinator Northern Alberta Vascular Center|
|Study Director:||Gerrit B Winkelaar, MD||Divisional Director and Clinical Head of Vascular Surgery for the Edmonton zone|