PICO Breast Reduction Clinical Study Looking at Incision Healing Complications

NCT01640366 | Completed Results FDA Device

• 1 other identifier: CE/US/11/01/PIC
• Study Type: interventional
• Target: 200
• Locations: 4 countries
• Sites: 6

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.

Conditions

Delayed Healing

Keywords

surgical incision; reduction mammoplasty; healing complications; negative pressure wound therapy

Outcome Measures

Primary Outcomes (1)

• Number of Participants Experiencing Incision Healing Complications up to Day 21 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.

  21 days postoperatively

Secondary Outcomes (8)

• 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 Participants Experiencing Postsurgical Incision Healing Complications (Delayed Healing) Occurring Within 7 Days Postoperatively

  Within 7 days postoperatively

• Number of Participants Experiencing Postsurgical Incision Healing Complications (Delayed Healing) Occurring Within 10 Days Postoperatively

  Within 10 days postoperatively

• Aesthetic Appearance (Cosmesis) and Scar Quality at 90 Days Postoperatively

  90 days postoperatively

Study Arms (2)

PICO negative pressure

EXPERIMENTAL

Single-use Negative Pressure Wound Therapy

Device: PICO

Standard of care dressing arm

NO INTERVENTION

Sterile gauze adhesive strips

Interventions

PICO DEVICE

Single-use Negative Pressure Wound Therapy System

Also known as: Disposable NPWT

PICO negative pressure

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Smith & Nephew, Inc.: lead

Study Sites (6)

Northwestern University Feinberg School of Medicine

Chicago, Illinois, 60611, United States

Location

Montefiore

The Bronx, New York, 10461, United States

Location

Cleveland Clinic

Cleveland, Ohio, 44195, United States

Location

CHU de Nantes Hôtel Dieu

Nantes, 44093, France

Location

Academisch Ziekenhuis Maastricht (AZM)

Maastricht, 6202, Netherlands

Location

University of Cape Town

Cape Town, South Africa

Location

MeSH Terms

Conditions

Surgical Wound

Condition Hierarchy (Ancestors)

Wounds and Injuries

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.

Results Point of Contact

• Title: Rachael Winter, Director of Clinical Operations
• Organization: Smith & Nephew Inc

rachael.winter@smith-nephew.com

+44 1482 673475

Study Officials

• Robert D Galiano, MD

  Northwestern University Feinberg School of Medicine

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: GT60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 3, 2012
• First Posted: July 13, 2012
• Study Start: June 1, 2012
• Primary Completion: April 1, 2014
• Study Completion: July 1, 2014
• Last Updated: February 28, 2020
• Results First Posted: February 28, 2020

Record last verified: 2020-02

Data Sharing

• IPD Sharing: Will not share

Locations

NL (1); US (3); FR (1); ZA (1)