Clinical trial NCT03948087: Comparison Between Postoperative Tubular Dressing and a Vacuum Removable Rigid Dressing After Transtibial Amputation
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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Amputation Stump
Peripheral Vascular Disease With Complications
Edema Leg
Wound Healing Delayed
Lead sponsor: Covenant Health, Canada
Sponsor class: OTHER
Collaborators: name: Alberta Innovates Health Solutions
First posted: 2019-05-13
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
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).
Primary purpose: TREATMENT

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.

Detailed description: The gold standard after transtibial amputation is casting of the residual limb to limit room for post-surgical edema, enable faster wound healing and shorter hospital stays, as well as, reduce time to prosthetic fitting. Casting also reduces the risk of impact damage to the limb. Casting, however, is costly and impractical due to the requirement of a prosthetist available on call for after emergency amputation surgeries and a need for multiple repeat prosthetist visits to cut off and reapply casting after wound healing checks. Thus current practice involves use of a compression elastic tube bandage (like a tensor bandage) applied within 15 minutes after surgery. However this bandage applies pressure to the residual limb, which can increase risk of reduced blood supply to the healing limb especially in vascular compromised patients. Further, this soft bandage does not offer any protection to the residual limb, a fall or severe contusion could lead to a requirement for costly revision surgery. There is evidence that rigid removable dressings can improve wound healing times, protect the limb, prevent contractures and enable earlier prosthetic fitting. This study aims to examine the the differences in wound healing time, changes in limb edema, knee range of motion, limb protection post falls, device application time, time to prosthetic fitting and cost between currently used postoperative soft dressing (SD) and vacuum removable rigid dressing (VRRD) after transtibial amputation.

Eligibility criteria: Inclusion Criteria:

1. 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.
2. 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.
3. Greater than 18 years of age

   Justification: Below the age of 18 informed consent must be obtained by a parent or guardian
4. Patient must be able to speak and understand English in order to provide informed consent. No reliance on translator services will be implemented.
5. 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.

Exclusion Criteria:

1. Severe dementia or insufficient cognition.

   Justification: Inability to provide informed consent to participate in the study.
2. 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.
3. 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.
4. 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.
5. 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.

Primary outcomes:
measure: Evaluation of Change in Stump Wound Healing
timeFrame: Day 3,7,14,30,48
Secondary outcomes:
measure: Evaluation of Change in Level of Limb Edema
timeFrame: Day 3,7,14,30,48
measure: Evaluation of Change in Knee Range of Motion
timeFrame: Day 3,7,14,30,48
measure: Rate of Revision Post Falls
timeFrame: Until prosthetic limb fit, on average 2 months.
measure: Total Amount of Time to Apply, Change, Clean and Alter the Dressings
timeFrame: Until discharge from acute care, on average 2 weeks.
measure: Length of time Until the Residual Limb is Ready for Prosthetic Fitting
timeFrame: Through study completion, on average 2 months.
measure: Total Length of Stay in Acute and Sub-acute Care Facilities
timeFrame: Through study completion, on average 3 weeks.
Other outcomes:
Locations:
Study officials:
affiliation: Amputee Coordinator Northern Alberta Vascular Center
name: Trent I Duchscherer, MSc
role: PRINCIPAL_INVESTIGATOR
affiliation: Divisional Director and Clinical Head of Vascular Surgery for the Edmonton zone
name: Gerrit B Winkelaar, MD
role: STUDY_DIRECTOR
References: