NL-OMON36873
Completed
Not Applicable
A prospective, randomized, intra-patient, comparative, open, multi-centre study to evaluate the efficacy of a Single-Use Negative Pressure Wound Therapy (NPWT) System (PICO) on the prevention of postsurgical incision healing complications in patients undergoing reduction mammoplasty - The effectivity of a negative pressure system (PICO)
Smith&Nephew, Inc0 sites30 target enrollmentTBD
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- bilaterale mammoplasty
- Sponsor
- Smith&Nephew, Inc
- Enrollment
- 30
- Status
- Completed
- Last Updated
- 2 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Pre\-surgery
- •1 \* Female patient\*s \*18 years old
- •2 \- The patient is able to understand the trial and is willing to consent to the trial
- •Post\-surgery;3 \* Patient has undergone an elective surgical procedure for bilateral reduction mammoplasty;4 \- Patients postsurgical incisions are of similar length
Exclusion Criteria
- •Pre\-surgery
- •Pregnant or lactating females
- •5 \* Pregnant or lactating females;6 \* Patients on steroids or other immune modulators known to impact healing which may affect scar appearance;7 \* Patients with tattoos in the area of the incisions;8 \* Patients with skin conditions (Cutis laxa etc.) that would result in poor healing or widened scars;9 \* Patients with a known significant history of scar problems i.e. hypertrophic scaring or keloids;10 \* Patients who in the opinion of the investigator may not complete the study for any reason;11 \* Patients with a known history of poor compliance with medical treatment;12 \* Patients who have participated in this trial previously and who were withdrawn;13 \* Patients with known allergies to product components (silicone adhesives and polyurethane films (direct contact with wound), acrylic adhesives (direct contact with skin), polyethylene fabrics and super\-absorbent powders (polyacrylates) (within the dressing);Post\-surgery;14 \- Incisions that are actively bleeding;15 \- Exposure of blood vessels, organs, bone or tendon at the base of the reference wound;16 \- Incisions \>12 inches (30cm) max linear dimension
Outcomes
Primary Outcomes
Not specified
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