A Prospective, Randomized, Intra-patient, Comparative, Open, Multi-centre Study to Evaluate the Efficacy of a Single-Use NPWT System on the Prevention of Incision Healing Complications in Patients Undergoing Reduction Mammoplasty
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Smith & Nephew, Inc.
- Enrollment
- 200
- Locations
- 6
- Primary Endpoint
- Number of Participants Experiencing Incision Healing Complications up to Day 21 Postoperatively
Study Overview
Brief Summary
The purpose of this study is to see if the use of a single-use negative pressure wound therapy system (NPWT) will have an effect on the reduction of post-surgical incision healing complications following breast reduction surgery and to assess the medium-term aesthetic appearance and quality of the resultant scar, compared with standard of care dressings.
Detailed Description
The aim of the present study is to assess the efficacy and cost-effectiveness of the Single-Use Negative Pressure Wound Therapy (NPWT) system (PICO) with regard to the reduction of postsurgical incision healing complications during the immediate postoperative treatment phase, and to assess the medium-term aesthetic appearance and quality of the resultant scar, in patients undergoing reduction mammoplasty, compared to standard care.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Prevention
- Masking
- Single (Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Female patient's ≥ 18 years old
- •The patient is able to understand the trial and is willing to consent to the trial
- •Patient has undergone an elective surgical procedure for bilateral reduction mammoplasty
- •Patients postsurgical incisions are of similar length
Exclusion Criteria
- •Pregnant or lactating females
- •Patients on steroids or other immune modulators known to impact healing which may affect scar appearance
- •Patients with tattoos in the area of the incisions
- •Patients with skin conditions (Cutis laxa etc.) that would result in poor healing or widened scars
- •Patients with a known significant history of scar problems i.e. hypertrophic scaring or keloids
- •Patients who in the opinion of the investigator may not complete the study for any reason
- •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 wound), acrylic adhesives (direct contact with skin), polyethylene fabrics and super-absorbent powders (polyacrylates) (within the dressing)
- •Incisions that are actively bleeding
- •Exposure of blood vessels, organs, bone or tendon at the base of the reference wound
- •Incisions > 12 inches (30cm) max linear dimension
Arms & Interventions
PICO negative pressure
Single-use Negative Pressure Wound Therapy
Intervention: PICO (Device)
Standard of care dressing arm
Sterile gauze adhesive strips
Outcomes
Primary Outcomes
Number of Participants Experiencing Incision Healing Complications up to Day 21 Postoperatively
Time Frame: 21 days postoperatively
The primary variable of whether or not the incision developed a healing complication within 21 days of surgery was defined as the presence of at least one of the following: 1. Infection (superficial or deep), 2. Dehiscence (partial, superficial or deep), 3. Delayed healing (defined as incision not closed within 7 days of the first surgical procedure). All participants received both PICO and standard care dressings simultaneously during the course of the study; randomized to either right breast for PICO and left breast for standard of care OR right breast standard of care and left breast PICO.
Secondary Outcomes
- Number of Participants Experiencing Postsurgical Incision Healing Complications (Dehiscence) Occurring up to Day 21 Postoperatively(21 days postoperatively)
- Number of Participants Experiencing Postsurgical Incision Healing Complications (Infection) Occurring up to Day 21 Postoperatively(21 days postoperatively)
- Number of Hematoma's Occurring up to and 21 Days Postoperatively(21 days postoperatively)
- Number of Wounds Showing 100% Closure Occurring up to and 21 Days Postoperatively(21 days postoperatively)
- Aesthetic Appearance (Cosmesis) and Scar Quality at 90 Days Postoperatively(90 days postoperatively)
- Number of Participants Experiencing Postsurgical Incision Healing Complications (Delayed Healing) Occurring Within 10 Days Postoperatively(Within 10 days postoperatively)
- Number of Participants Experiencing Postsurgical Incision Healing Complications (Delayed Healing) Occurring Within 7 Days Postoperatively(Within 7 days postoperatively)
- Number of Skin, Nipple and Areola Necrosis Occurring up to and 21 Days Postoperatively(21 days postoperatively)