PICO Breast Reduction Clinical Study Looking at Incision Healing Complications

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.

• PICO (Device), also known as Disposable NPWT: Single-use Negative Pressure Wound Therapy System

Primary outcomes

• Number of Participants Experiencing Incision Healing Complications up to Day 21 Postoperatively [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]: Assessment of the number of participants' incisions that experienced dehiscence (superficial, partial, or deep) occurring up to and 21 days postoperatively between incisions treated with PICO compared with standard care dressings. 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.
• Number of Participants Experiencing Postsurgical Incision Healing Complications (Infection) Occurring up to Day 21 Postoperatively [21 days postoperatively]: Assessment of the number of participants' incisions that experienced an infection (superficial or deep) occurring up to and 21 days postoperatively between incisions treated with PICO compared with standard care dressings. 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.
• Number of Participants Experiencing Postsurgical Incision Healing Complications (Delayed Healing) Occurring Within 7 Days Postoperatively [Within 7 days postoperatively]: Assessment of the number of participants' incisions that experienced delayed healing within 7 days of surgery between incisions treated with PICO compared with standard care dressings. 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.
• Number of Participants Experiencing Postsurgical Incision Healing Complications (Delayed Healing) Occurring Within 10 Days Postoperatively [Within 10 days postoperatively]: Assessment of the number of participants' incisions that experienced delayed healing within 10 days of surgery between incisions treated with PICO compared with standard care dressings. 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.
• Aesthetic Appearance (Cosmesis) and Scar Quality at 90 Days Postoperatively [90 days postoperatively]: Assessment of the Patient and Observer Scar Assessment Scale (POSAS) and the Visual Analogue Scale (VAS) between postsurgical incisions treated with PICO compared with standard care dressings. VAS score: Assessed for color, appearance, contour, distortion, and texture. Each score ranged from 5 to 18; 5 being 'excellent' and 18 being 'poor.' Also, a global scar score was included in the total score. POSAS score: Scored in 2 parts which added to create a total score, observer score and patient score. The lowest score of 1 showed 'normal' skin and the highest score of 10 showed the 'worst imaginable' result. Observer score = 6 categories (vascularity, pigmentation, thickness, relief, pliability, and surface area) each given a score of 1-10. Patient score = 6 categories (scar pain, itching, color, stiffness, thickness, and irregularity each given a score of 1-10. All participants received both PICO and standard care dressings simultaneously during the course of the study.
• Number of Skin, Nipple and Areola Necrosis Occurring up to and 21 Days Postoperatively [21 days postoperatively]: The nipple and areola areas were not covered by the PICO or standard care dressing as part of the evaluation, they were all dressed the same with Steri-strips and dry gauze pads, which was essentially the standard care dressing regime. 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.
• Number of Hematoma's Occurring up to and 21 Days Postoperatively [21 days postoperatively]: Assessment of participants developing a hematoma up to 21 days postoperatively for incisions treated with PICO compared with standard care dressings. 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.
• Number of Wounds Showing 100% Closure Occurring up to and 21 Days Postoperatively [21 days postoperatively]: Assessment of wound appearance demonstrating 100% wound closure at 21 days postoperatively for both PICO treatment and standard of care treatment. 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.

Sex: Female, ages: 18 Years to any

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

Participant flow

Outcome results

• Number of Participants Experiencing Incision Healing Complications up to Day 21 Postoperatively (Primary), Number, participants: PICO Negative Pressure Wound Therapy/Standard of Care Dressing 113
• Number of Participants Experiencing Postsurgical Incision Healing Complications (Dehiscence) Occurring up to Day 21 Postoperatively (Secondary), Number, participants: PICO Negative Pressure Wound Therapy 32
• Number of Participants Experiencing Postsurgical Incision Healing Complications (Infection) Occurring up to Day 21 Postoperatively (Secondary), Number, participants: PICO Negative Pressure Wound Therapy/Standard of Care Dressing 4
• Number of Participants Experiencing Postsurgical Incision Healing Complications (Delayed Healing) Occurring Within 7 Days Postoperatively (Secondary), Number, participants: PICO Negative Pressure Wound Therapy/Standard of Care Dressing 102
• Number of Participants Experiencing Postsurgical Incision Healing Complications (Delayed Healing) Occurring Within 10 Days Postoperatively (Secondary), Number, participants: PICO Negative Pressure Wound Therapy/Standard of Care Dressing 64
• Aesthetic Appearance (Cosmesis) and Scar Quality at 90 Days Postoperatively (Secondary), Median, score on a scale: PICO Negative Pressure Wound Therapy/Standard of Care Dressing 3 (1 to 9)
• Number of Skin, Nipple and Areola Necrosis Occurring up to and 21 Days Postoperatively (Secondary), Count of participants, Participants: PICO Negative Pressure Wound Therapy/Standard of Care Dressing 2
• Number of Hematoma's Occurring up to and 21 Days Postoperatively (Secondary), Count of participants, Participants: PICO Negative Pressure Wound Therapy/Standard of Care Dressing 2
• Number of Wounds Showing 100% Closure Occurring up to and 21 Days Postoperatively (Secondary), Count of participants, Participants: PICO Negative Pressure Wound Therapy/Standard of Care Dressing 155

Adverse events

Time frame: Baseline through 90 days postoperatively.

Serious adverse events by term

Other adverse events by term

Limitations and caveats: There was one site (68 enrolled participants in total) in which the data were analyzed separately due to issues at the site. This data was also analyzed and included in the overall totals for baseline characteristics and outcome measures.

• Robert D Galiano, MD, Principal investigator, Northwestern University