Status:
NOT_YET_RECRUITING
CiNPWT Lower Extremity Amputations (Closed Incision Neagtive Pressure Wound Therapy)
Lead Sponsor:
University of Southern California
Collaborating Sponsors:
3M
Conditions:
Wound Heal
Wound Dehiscence
Eligibility:
All Genders
18+ years
Phase:
PHASE1
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 (...
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 ...
Eligibility Criteria
Inclusion
- 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)
Exclusion
Key Trial Info
Start Date :
July 25 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 30 2025
Estimated Enrollment :
10 Patients enrolled
Trial Details
Trial ID
NCT06493539
Start Date
July 25 2024
End Date
June 30 2025
Last Update
July 10 2024
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