Amputation Clinical Trial
Official title:
Evaluation of Closed Incision Negative Pressure Dressing (PREVENA) to Prevent Lower Extremity Amputation Wound Complications
This study is a prospective, multi-center, two-arm, unblinded, and randomized controlled trial with a goal of evaluating the impact of a closed incision negative pressure dressing (PREVENA) on incidence of post-operative wound complications and medical costs in patients undergoing lower extremity amputation.
This is a prospective, multi-center, two-arm, unblinded, randomized controlled trial to evaluate the impact of a closed incision negative pressure dressing (PREVENA™ PEEL & PLACE™ Dressing Kit) on incidence of post-operative wound complications in patients undergoing above-the-knee (AKA) or below-the-knee (BKA) amputation. Up to 440 subjects at approximately five (5) participating sites will be randomized to receive either the Prevena dressing or a standard care dressing. The incision will be assessed for complications at post-op day 5 or day 6 and at approximately 30 days after discharge. The primary outcome of this study is reported wound complications, including dehiscence (opening of the incision), seroma, lymph leak, infection (deep or superficial), hematoma (blood clots), ischemia (decreased blood supply), and necrosis (tissue death) A major complication is defined as any wound complication requiring intravenous or oral antibiotics, reoperation and/or hospital readmission. All data (demographics, medical history, and clinical outcomes) will be collected via medical record review ;
Status | Clinical Trial | Phase | |
---|---|---|---|
Recruiting |
NCT03947450 -
Autologous Volar Fibroblast Injection Into the Stump Site of Amputees
|
Phase 2 | |
Completed |
NCT04924036 -
Qbrexza Cloths for Hyperhidrosis of Amputation Sites
|
Phase 2 | |
Recruiting |
NCT04839497 -
Multicenter Trial Evaluating the Safety and Efficacy of Autologous Volar Fibroblast Injection Into the Terminal Limb of Amputees.
|
Phase 2 | |
Recruiting |
NCT04212299 -
Transfemoral Socket Design and Muscle Function
|
N/A | |
Completed |
NCT03733054 -
Understanding Prosthetic Needs and Outcomes in Women Veterans With Amputation
|
||
Completed |
NCT03651830 -
A Test-Drive Strategy for the Prescription of Prosthetic Feet for People With Leg Amputations
|
N/A | |
Recruiting |
NCT04725006 -
Sensory Responses to Dorsal Root Stimulation
|
N/A | |
Not yet recruiting |
NCT06007885 -
Examining Capacity Building of Youth With Physical Disabilities to Pursue Participation Following the PREP Intervention.
|
N/A | |
Not yet recruiting |
NCT04936789 -
Clinical Feasibility of the IMES Transradial Prosthesis
|
N/A | |
Completed |
NCT01155024 -
Clinical Evaluation of Direct Manufactured Prosthetic Sockets
|
Phase 2 | |
Completed |
NCT00663663 -
Telephone Intervention for Pain Study (TIPS)
|
N/A | |
Terminated |
NCT00778856 -
Hand Transplantation for the Reconstruction of Below the Elbow Amputations
|
N/A | |
Recruiting |
NCT00388752 -
Acupuncture for the Treatment of Phantom Limb and Residual Limb Pain After Amputation
|
Phase 1 | |
Active, not recruiting |
NCT03374319 -
Somatotopic Configuration of Distal Residual Limb Tissues in Lower Extremity Amputations
|
N/A | |
Completed |
NCT05542901 -
Comparison of Joint Position Sense in Diabetic and Traumatic Transtibial Amputees
|
N/A | |
Completed |
NCT05161364 -
Kinetic Analysis Due to Foot Dysfunction
|
||
Recruiting |
NCT06194838 -
Clinical Outcomes With Non-Powered vs. Powered Prosthetic Knees by K2-level Amputees
|
N/A | |
Completed |
NCT03570788 -
HRQoL Among Patients Amputated Due to Peripheral Arterial Disease
|
||
Completed |
NCT05778799 -
Physical Activity and Sports for People With Special Needs
|
||
Recruiting |
NCT04804150 -
Daily Socket Comfort in Transtibial Amputee With an Active Vacuum Suspension System
|
N/A |