Last updated: February 16, 2024
Sponsor: Icahn School of Medicine at Mount Sinai
Overall Status: Terminated
Phase
N/A
Condition
Diabetic Foot Ulcers
Diabetic Gastroparesis
Obesity
Treatment
Optifoam
Avance Solo
Clinical Study ID
NCT05427916
STUDY-22-00329
Ages > 18 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
- The patient must be at least 18 years of age.
- Males and females - provided they are not pregnant and if of reproductive age areusing 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 theevaluation.
- 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 beexcluded from this study.
Exclusion
Exclusion Criteria:
- 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- Patients who have participated in this trial previously and who were withdrawn.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 andpolyurethane films (direct contact with incision), acrylic adhesives (direct contactwith skin), polyethylene fabrics and super-absorbent powders (polyacrylates) (withinthe dressing).
- Incisions where daily inspection is required underneath the dressing.
- Incisions which have an infection which is not being treated with systemicantibiotics.
- Incisions which are actively bleeding.
- Exposure of blood vessels, organs, bone or tendon at the base of the referenceincision.
Study Design
Total Participants: 20
Treatment Group(s): 2
Primary Treatment: Optifoam
Phase:
Study Start date:
July 12, 2022
Estimated Completion Date:
February 17, 2023
Study Description
Connect with a study center
Lauren Rodio
New York, New York 10019
United StatesSite Not Available
Mount Sinai West
New York, New York 10019
United StatesActive - Recruiting

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