Closed Incision Negative Pressure Wound Therapy vs. Foam as Post Operative Dressing (NCT05427916) | Clinical Trial Compass
TerminatedNot Applicable
Closed Incision Negative Pressure Wound Therapy vs. Foam as Post Operative Dressing
Stopped: Site decided not to continue
United States20 participantsStarted 2022-07-12
Plain-language 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 versus a highly absorbent antimicrobial post - operative absorbent dressing.
Who can participate
Age range18 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 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 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* Patients who have participated in this trial previously and who were withdrawn.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 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 whi…