CiNPWT Lower Extremity Amputations (Closed Incision Neagtive Pressure Wound Therapy)

Launched by UNIVERSITY OF SOUTHERN CALIFORNIA · Jul 1, 2024

Keywords

ClinConnect Summary

This clinical trial is studying a new treatment called Closed Incision Negative Pressure Wound Therapy (CiNPWT) to help heal wounds after lower limb amputations. The goal is to see if using this special therapy, delivered by the V.A.C. Ulta™ Therapy System, can improve healing compared to the usual care methods, which involve wrapping the wound in compression bandages. The study will involve about 6 to 10 participants who have had an amputation, and they will be divided into two groups—one receiving the new therapy and the other receiving standard care.

To participate, individuals must be at least 18 years old and have a closed incision from their amputation, with no signs of infection. They should also have good blood flow to the area. However, those with certain conditions, such as severe diabetes, ongoing infections, or specific allergies to the therapy, won't be eligible. Participants can expect to be monitored closely throughout the study, and they also have the option to withdraw at any time. This trial is not yet recruiting, but it hopes to find new ways to improve recovery for those who have had lower limb amputations.

Gender

ALL

Eligibility criteria

• Inclusion criteria to select the participants (intervention and control):
• • Individual aged 18 years or older
• • Individual with a closed incision following LEA (transmetatarsal or proximal)
• • Individual presents with adequate perfusion based on WIfI ischemia component score of less than 2 (\>30mm Hg TCPO2 or higher at region of amputation)
• • Individual presents with no residual surgical site infection (WIfI grade 0) post LEA
• • Individual is competent to make their own medical decisions
• Exclusion criteria (intervention and control):
• • Individual presents with any defined contraindications to NPWT (e.g., allergy).
• • Individual presents with residual acute osteomyelitis (after amputation).
• • Individual with collagen vascular disease or malignant disease in the wound
• • Individual has uncontrolled hyperglycemia (glycosylated hemoglobin \[HbA1c\]\>12%).
• • Individual is currently taking corticosteroids, immunosuppressive drugs, or chemotherapy and is not on stable course of therapy as determined by principal investigator
• • Individual has a history of local radiation therapy that could impact the edema of the amputated limb.
• • Individual has pre-existing conditions contributing to residual limb edema (i.e., nephropathy, congestive heart failure, primary lymphedema, etc.).
• Withdrawal of individuals:
• • Voluntary withdrawal
• • Death
• • Lost to follow-up
• • Termination of compression therapy (control or intervention group)