Comparison Between Postoperative Tubular Dressing and a Vacuum Removable Rigid Dressing After Transtibial Amputation

NCT03948087 | Unknown

• 1 other identifier: EMPAR
• Study Type: interventional
• Target: 100
• Locations: 0 countries
• Sites: N/A

Brief Summary

Comparison of wound healing, edema level, knee range of motion, rate of revision post falls, device application time, time to prosthetic fit, and cost between postoperative soft dressing and a vacuum removable rigid dressing after unilateral transtibial amputation.

Conditions

Amputation Stump; Peripheral Vascular Disease With Complications; Edema Leg; Wound Healing Delayed

Outcome Measures

Primary Outcomes (1)

• Evaluation of Change in Stump Wound Healing

  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.

  Day 3,7,14,30,48

Secondary Outcomes (6)

• Evaluation of Change in Level of Limb Edema

  Day 3,7,14,30,48

• Evaluation of Change in Knee Range of Motion

  Day 3,7,14,30,48

• Rate of Revision Post Falls

  Until prosthetic limb fit, on average 2 months.

• Total Amount of Time to Apply, Change, Clean and Alter the Dressings

  Until discharge from acute care, on average 2 weeks.

• Length of time Until the Residual Limb is Ready for Prosthetic Fitting

  Through study completion, on average 2 months.

Study Arms (2)

Vacuum Removable Rigid Dressing (VRRD)

EXPERIMENTAL

Application of a Vacuum Removable Rigid Dressing (VRRD)

Device: Vacuum Removable Rigid Dressing (VRRD)

Soft Dressing Control Group

NO INTERVENTION

Application of standard of care soft dressing (SD) intra-operatively.

Interventions

Vacuum Removable Rigid Dressing (VRRD) DEVICE

Intra-operative application of device.

Also known as: Ossur (TM) Rigid Dressing (ORD)

Vacuum Removable Rigid Dressing (VRRD)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Transtibial amputation related to peripheral vascular disease with or without diabetes or trauma.
• Justification: The form and function of the ORD device relates solely to transtibial amputees. The device is not useable for any other limb amputation type (e.g. transfemoral, transmetatarsal). The choice of using vascular compromised participants is intentional. Ischemia and necrosis rapidly ensue as a result of vessel occlusion which can easily happen with any external compressive force (e.g. tensor bandaging). The ORD does not apply compressive force to the residual limb.
• Transtibial amputation that includes myodesis and/or myoplasty.
• Justification: Myoplasty and myodesis are preferred surgical techniques while performing an amputation. They involve the surgical attachment of muscle to muscle (myoplasty) or muscle to bone (myodesis) across the end of the residual limb prior to skin flap closure. This allows increased stability and provides a better interface with a future prosthetic device.
• Greater than 18 years of age
• Justification: Below the age of 18 informed consent must be obtained by a parent or guardian
• Patient must be able to speak and understand English in order to provide informed consent. No reliance on translator services will be implemented.
• Has no major illness where life expectancy is less than 2 years.
• Justification: This is the study timeline and co-morbidities that limit participation within this timeframe will introduce confounding factors.

You may not qualify if:

• Severe dementia or insufficient cognition.
• Justification: Inability to provide informed consent to participate in the study.
• Knee contracture greater than 30 degrees
• Justification: The ORD will not fit a limb with too much flexion at the knee. Wound healing is also affected due to pressure across the end of the residual limb without the use of offloading techniques.
• Severe peripheral vascular disease involving the contralateral lower limb
• Justification: Having severe peripheral vascular disease to the contralateral limb may affect the secondary outcome measures due to the need for further medical or surgical intervention.
• Inability to speak, read, or understand English.
• Justification: For a patient to participate in the study informed consent must be obtained. There is a high probability that there would be too much variability among translators (family member or institutional) to ensure consistent informed consent.
• Neurological condition or medical disorder that could affect rehabilitation.
• Justification: Rehabilitation post transtibial amputation is critical to overall functional outcomes as well as study outcomes. If a patient has difficulty with participation in rehabilitation then this will be a confounding factor.

Sponsors & Collaborators

• Covenant Health, Canada: lead
• Alberta Innovates Health Solutions: collaborator

Study Officials

• Trent I Duchscherer, MSc

  Amputee Coordinator Northern Alberta Vascular Center

  PRINCIPAL INVESTIGATOR

• Gerrit B Winkelaar, MD

  Divisional Director and Clinical Head of Vascular Surgery for the Edmonton zone

  STUDY DIRECTOR

Central Study Contacts

Amputee Coordinator

CONTACT

780-735-7161; trent.duchscherer@covenanthealth.ca

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Amputee Coordinator Northern Alberta Vascular Center

Model Details: 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).

Study Record Dates

• First Submitted: February 27, 2019
• First Posted: May 13, 2019
• Study Start: May 1, 2019
• Primary Completion: October 1, 2020
• Study Completion: May 1, 2021
• Last Updated: May 13, 2019

Record last verified: 2019-05

Data Sharing

• IPD Sharing: Will not share