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
- Conditions
- bilaterale mammoplasty1000225210040795
- Registration Number
- NL-OMON36873
- Lead Sponsor
- Smith&Nephew, Inc
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 30
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
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of poor compliance with medical treatment;12 * Patients who have participated in this trial previously and who were withdrawn;13 * Patients with known allergies to product components (silicone adhesives and polyurethane films (direct contact with wound), acrylic adhesives (direct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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>To assess the difference in healing complications up to and 21 days<br /><br>post-operatively between postsurgical incisions treated with PICO compared with<br /><br>standard of care</p><br>
- Secondary Outcome Measures
Name Time Method <p>To assess the aesthetic appearance and scar quality using POSAS-, VAS<br /><br>Questionnaires and the hydratation, elasticity and the Transepidermal Water<br /><br>Loss of the scar using the cutometer , the aspects of functional performance of<br /><br>both dressings, the ease of operation of the PICO pump, any changes in the<br /><br>surrounding skin condition and the assessment of a difference in the following<br /><br>economic assessments</p><br>