Status:
TERMINATED
Closed Incision Negative Pressure Wound Therapy vs. Foam as Post Operative Dressing
Lead Sponsor:
Icahn School of Medicine at Mount Sinai
Conditions:
Diabetes
Morbid Obesity
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
The primary objective is to assess the frequency of a wound healing complication, in a closed incisional wound in a "high risk" surgical incision when treated with Negative Pressure Wound Therapy vers...
Detailed Description
A healing complication is defined as presence of at least one of the following conditions: infection (superficial or deep), dehiscence (partial, superficial, or deep), or delayed healing (incision not...
Eligibility Criteria
Inclusion
- The patient must be at least 18 years of age.
- Males and females - provided they are not pregnant and if of reproductive age are using contraception.
- Have a closed surgical incision post-surgery/closure (\<24 hours after).
- The patient is able to understand the evaluation and is willing to consent to the evaluation.
- Undergoing appropriate: wound "high risk" surgery.
- Foot and ankle surgery.
- Vascular groin incision.
- Long leg vein harvest incision.
- Closed forefoot and major amputation surgery.
- Possibly: breast augmentation and reduction surgery.
- HIV and hepatitis positive patients will not be excluded from this study.
- Renal failure patients will not be excluded.
- Patient on metabolic agent, immunosuppressants, or steroid therapy will not be excluded from this study.
Exclusion
- Incisions in excess of effective dressing pad size provided.
- Patients with a known history of poor compliance with medical treatment.
- Patients who have participated in this trial previously and who were withdrawn.
- Patients with known allergies to product components (silicone adhesives and polyurethane films (direct contact with incision), acrylic adhesives (direct contact with skin), polyethylene fabrics and super-absorbent powders (polyacrylates) (within the dressing).
- Incisions where daily inspection is required underneath the dressing.
- Incisions which have an infection which is not being treated with systemic antibiotics.
- Incisions which are actively bleeding.
- Exposure of blood vessels, organs, bone or tendon at the base of the reference incision.
Key Trial Info
Start Date :
July 12 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 17 2023
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT05427916
Start Date
July 12 2022
End Date
February 17 2023
Last Update
March 13 2024
Active Locations (1)
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1
Lauren Rodio
New York, New York, United States, 10019