CiNPWT Lower Extremity Amputations (Closed Incision Neagtive Pressure Wound Therapy)
brief summary
The objective of this study is to evaluate prospectively the effect of a novel application of Closed Incision Negative Pressure Wound Therapy(CiNPWT), as delivered by the V.A.C. Ulta™ Therapy System (3M, USA) in individuals who have undergone a Lower Extremity Amputation(LEA) compared with standard of care compression wrapping and wound care post-LEA. This a pilot-controlled exploratory trial including approximately 6-10 individuals who have undergone LEA (trans-metatarsal or higher) randomized between intervention (novel application of CiNPWT) and a control group (standard care).
detailed description
The objective of this study is to evaluate prospectively the effect of a novel application of Closed Incision Negative Pressure Wound Therapy (CiNPWT), as delivered by the V.A.C. Ulta™ Therapy System (3M, USA) in individuals who have undergone a Lower Extremity Amputation (LEA) compared with standard of care compression wrapping and wound care post-LEA.
Specific objectives:
1. Collect demographics and relevant data (e.g., risk factors and comorbidities) to compare intervention and control groups. 2. Measure post-surgical outcomes and compare both groups.
STUDY DESIGN
This a pilot-controlled exploratory trial including approximately 6-10 individuals who have undergone LEA (trans-metatarsal or higher) randomized between intervention (novel application of CiNPWT) and a control group (standard care).
DEVICE INFORMATION
The V.A.C. Ulta™ Therapy System (3M, USA) is a non-invasive wound closure system that uses controlled, localized negative pressure to promote healing in chronic and acute wounds. The subatmospheric (ie. negative) pressure system uses latex-free and sterile polyurethane or polyvinyl alcohol foam dressings that are individualized at the bedside to the appropriate size for every patient, and then covered with an adhesive drape to create an airtight seal. A SensaT.R.A.C.™ Pad directly contacts the foam dressing, and accurately senses, monitors, and maintains the target pressure at the wound site to provide controlled negative pressure. Tubing attached to the SensaT.R.A.C.™ Pad connects to a fluid collection canister contained in a programmable, portable, computer-controlled vacuum pump creating negative pressure at the wound surface interface.
Amputation (and revision/re-amputation) is a resection of a segment of a limb through a bone or through a joint.
Major amputation: Any resection proximal to the ankle.
Major amputation levels:
TT = transtibial amputation: amputation through the tibia and fibula (frequently referred to as "below knee amputation").
KD = knee disarticulation: amputation through the knee (frequently referred to as "through knee amputation").
official title
A Novel Application of Closed Incision Negative Pressure Wound Therapy for the Post-Surgical Management of Lower Extremity Amputations: A Randomized Clinical Pilot Study