Closed Incision Negative Pressure Wound Therapy vs. Foam as Post Operative Dressing

Stopped early · Not applicable

Conditions studied: Diabetes, Morbid Obesity, Lymphedema, Orthopedic Disorder

In brief

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 versus a highly absorbent antimicrobial post - operative absorbent dressing.

Key facts

Study ID

NCT05427916

Run by

Icahn School of Medicine at Mount Sinai

People needed

20

Starts

2022-07-12

Expected to finish

2023-02-17

Last updated by the study team

2024-03-13

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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• Patients who have participated in this trial previously and who were withdrawn.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.

Where it is running

• Lauren Rodio — New York, New York, United States

Full record on ClinicalTrials.gov

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