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PICO Breast Reduction Clinical Study Looking at Incision Healing Complications

Primary Purpose

Delayed Healing

Status
Completed
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
PICO
Sponsored by
Smith & Nephew, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Delayed Healing focused on measuring surgical incision, reduction mammoplasty, healing complications, negative pressure wound therapy

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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  • Patients who have participated in this trial previously and who were withdrawn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

Sites / Locations

  • Northwestern University Feinberg School of Medicine
  • Montefiore
  • Cleveland Clinic
  • CHU de Nantes Hôtel Dieu
  • Academisch Ziekenhuis Maastricht (AZM)
  • University of Cape Town

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

PICO negative pressure

Standard of care dressing arm

Arm Description

Single-use Negative Pressure Wound Therapy

Sterile gauze adhesive strips

Outcomes

Primary Outcome Measures

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: Infection (superficial or deep), Dehiscence (partial, superficial or deep), 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 Outcome Measures

Number of Participants Experiencing Postsurgical Incision Healing Complications (Dehiscence) Occurring up to Day 21 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
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
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
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
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
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
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
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.

Full Information

First Posted
July 3, 2012
Last Updated
February 13, 2020
Sponsor
Smith & Nephew, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT01640366
Brief Title
PICO Breast Reduction Clinical Study Looking at Incision Healing Complications
Official Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
February 2020
Overall Recruitment Status
Completed
Study Start Date
June 2012 (undefined)
Primary Completion Date
April 2014 (Actual)
Study Completion Date
July 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Smith & Nephew, Inc.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Delayed Healing
Keywords
surgical incision, reduction mammoplasty, healing complications, negative pressure wound therapy

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
200 (Actual)

8. Arms, Groups, and Interventions

Arm Title
PICO negative pressure
Arm Type
Experimental
Arm Description
Single-use Negative Pressure Wound Therapy
Arm Title
Standard of care dressing arm
Arm Type
No Intervention
Arm Description
Sterile gauze adhesive strips
Intervention Type
Device
Intervention Name(s)
PICO
Other Intervention Name(s)
Disposable NPWT
Intervention Description
Single-use Negative Pressure Wound Therapy System
Primary Outcome Measure Information:
Title
Number of Participants Experiencing Incision Healing Complications up to Day 21 Postoperatively
Description
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: Infection (superficial or deep), Dehiscence (partial, superficial or deep), 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.
Time Frame
21 days postoperatively
Secondary Outcome Measure Information:
Title
Number of Participants Experiencing Postsurgical Incision Healing Complications (Dehiscence) Occurring up to Day 21 Postoperatively
Description
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.
Time Frame
21 days postoperatively
Title
Number of Participants Experiencing Postsurgical Incision Healing Complications (Infection) Occurring up to Day 21 Postoperatively
Description
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.
Time Frame
21 days postoperatively
Title
Number of Participants Experiencing Postsurgical Incision Healing Complications (Delayed Healing) Occurring Within 7 Days Postoperatively
Description
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.
Time Frame
Within 7 days postoperatively
Title
Number of Participants Experiencing Postsurgical Incision Healing Complications (Delayed Healing) Occurring Within 10 Days Postoperatively
Description
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.
Time Frame
Within 10 days postoperatively
Title
Aesthetic Appearance (Cosmesis) and Scar Quality at 90 Days Postoperatively
Description
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.
Time Frame
90 days postoperatively
Title
Number of Skin, Nipple and Areola Necrosis Occurring up to and 21 Days Postoperatively
Description
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.
Time Frame
21 days postoperatively
Title
Number of Hematoma's Occurring up to and 21 Days Postoperatively
Description
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.
Time Frame
21 days postoperatively
Title
Number of Wounds Showing 100% Closure Occurring up to and 21 Days Postoperatively
Description
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.
Time Frame
21 days postoperatively

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Robert D Galiano, MD
Organizational Affiliation
Northwestern University Feinberg School of Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
Northwestern University Feinberg School of Medicine
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60611
Country
United States
Facility Name
Montefiore
City
Bronx
State/Province
New York
ZIP/Postal Code
10461
Country
United States
Facility Name
Cleveland Clinic
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44195
Country
United States
Facility Name
CHU de Nantes Hôtel Dieu
City
Nantes
ZIP/Postal Code
44093
Country
France
Facility Name
Academisch Ziekenhuis Maastricht (AZM)
City
Maastricht
ZIP/Postal Code
6202
Country
Netherlands
Facility Name
University of Cape Town
City
Cape Town
Country
South Africa

12. IPD Sharing Statement

Plan to Share IPD
No

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PICO Breast Reduction Clinical Study Looking at Incision Healing Complications

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