N/A
N=200
PICO Breast Reduction Clinical Study Looking at Incision Healing Complications
Delayed Healing
Bottom Line
View on ClinicalTrials.gov: NCT01640366 ↗Enrolled (actual)
200
Serious AEs
2.3%
Results posted
Feb 2020
Primary outcome: Primary: Number of Participants Experiencing Incision Healing Complications up to Day 21 Postoperatively — 113; 86; 123; 76 participants
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- PICO (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- Female
- Sponsor
- Smith & Nephew, Inc.
- Primary completion
- Apr 2014
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants Experiencing Incision Healing Complications up to Day 21 Postoperatively |
113; 86; 123; 76 | — |
| SECONDARY Number of Participants Experiencing Postsurgical Incision Healing Complications (Dehiscence) Occurring up to Day 21 Postoperatively |
32; 165; 52; 145 | — |
| SECONDARY Number of Participants Experiencing Postsurgical Incision Healing Complications (Infection) Occurring up to Day 21 Postoperatively |
4; 193; 6; 191 | — |
| SECONDARY Number of Participants Experiencing Postsurgical Incision Healing Complications (Delayed Healing) Occurring Within 7 Days Postoperatively |
102; 97; 103; 96 | — |
| SECONDARY Number of Participants Experiencing Postsurgical Incision Healing Complications (Delayed Healing) Occurring Within 10 Days Postoperatively |
64; 135; 64; 135 | — |
| SECONDARY Aesthetic Appearance (Cosmesis) and Scar Quality at 90 Days Postoperatively |
3; 3; 16; 18; 15; 19 | — |
| SECONDARY Number of Skin, Nipple and Areola Necrosis Occurring up to and 21 Days Postoperatively |
2; 7; 2; 1 | — |
| SECONDARY Number of Hematoma's Occurring up to and 21 Days Postoperatively |
2; 3 | — |
| SECONDARY Number of Wounds Showing 100% Closure Occurring up to and 21 Days Postoperatively |
155; 134 | — |
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.
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT01640366). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.