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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
100
Intra-operative application of device.
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.
Time frame: Day 3,7,14,30,48
Evaluation of Change in Level of Limb Edema
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
Time frame: Day 3,7,14,30,48
Evaluation of Change in Knee Range of Motion
Degrees measured via goniometry into knee flexion and extension for both active and passive range of motion.
Time frame: Day 3,7,14,30,48
Rate of Revision Post Falls
Falls sustained by study participants will be recorded. Whether a follow-up revision surgery was necessary will also be recorded.
Time frame: Until prosthetic limb fit, on average 2 months.
Total Amount of Time to Apply, Change, Clean and Alter the Dressings
Time log in minutes recorded by staff in real time providing care to study participants.
Time frame: Until discharge from acute care, on average 2 weeks.
Length of time Until the Residual Limb is Ready for Prosthetic Fitting
Time log in days beginning post operative day 1 until the study participant is fit with a definitive prosthetic limb.
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Time frame: Through study completion, on average 2 months.
Total Length of Stay in Acute and Sub-acute Care Facilities
A time log in days of how long a given study participant is admitted to an acute or sub-acute care facility.
Time frame: Through study completion, on average 3 weeks.