NCT03948087

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

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

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 100 (estimated)
• Sponsor: Covenant Health, Canada · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

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

Interventions

Type	Name	Description
DEVICE	Vacuum Removable Rigid Dressing (VRRD)	Intra-operative application of device.

Timeline

• Start date: 2019-05-01
• Primary completion: 2020-10-01
• Completion: 2021-05-01
• First posted: 2019-05-13
• Last updated: 2019-05-13