PICO Breast Reduction Clinical Study Looking at Incision Healing Complications
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ClinicalTrials.gov Identifier: NCT01640366 |
Recruitment Status
:
Completed
First Posted
: July 13, 2012
Last Update Posted
: January 11, 2016
|
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Delayed Healing | Device: PICO | Phase 4 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 200 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Single (Outcomes Assessor) |
Primary Purpose: | Prevention |
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 Start Date : | June 2012 |
Actual Primary Completion Date : | April 2014 |
Actual Study Completion Date : | July 2014 |

Arm | Intervention/treatment |
---|---|
Experimental: PICO negative pressure |
Device: PICO
Single-use negative pressure wound therapy system
Other Name: Disposible NPWT
|
No Intervention: Standard of care dressing arm |
- Difference in incision healing complications up to and 21 days post-operatively between postsurgical incisions treated with PICO compared with standard care [ Time Frame: 21 days ]To assess the difference in incision healing complications up to and 21 days post-operatively between postsurgical incisions treated with PICO compared with standard care
- To assess the number and type of any postsurgical incision healing complication occurring up to and 21 days post-operatively between incisions treated with PICO compared with standard care dressings [ Time Frame: 21 days ]
- To assess the aesthetic appearance (cosmesis) and scar quality at 42 and 90 days between postsurgical incisions treated with PICO compared with standard care dressings using POSAS and VAS [ Time Frame: 90 days ]The Patient and Observer Scar Assessment Scale (POSAS) and The Visual Analogue Scale (VAS)
- Difference in the amount of skin, nipple and areola necrosis occurring up to and 21 days post-operatively between incisions treated with PICO compared with standard care dressings [ Time Frame: 21 days ]
- Difference in the number of hematoma's occurring up to and 21 days post-operatively between incisions treated with PICO compared with standard care dressings [ Time Frame: 21 days ]
- Difference in the amount dehiscence occurring up to and 21 days post-operatively between incisions treated with PICO compared with standard care dressings [ Time Frame: 21 days ]
- Difference in the number of infections occurring up to and 21 days post-operatively between incisions treated with PICO compared with standard care dressings [ Time Frame: 21 days ]
- Difference in the number of seroma's occurring up to and 21 days post-operatively between incisions treated with PICO compared with standard care dressings. [ Time Frame: 21 days ]

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Ages Eligible for Study: | 18 Years and older (Adult, Senior) |
Sexes Eligible for Study: | 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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01640366
United States, Illinois | |
Northwestern University Feinberg School of Medicine | |
Chicago, Illinois, United States, 60611 | |
United States, New York | |
Montefiore | |
Bronx, New York, United States, 10461 | |
United States, Ohio | |
Cleveland Clinic | |
Cleveland, Ohio, United States, 44195 | |
Netherlands | |
Academisch Ziekenhuis Maastricht (AZM) | |
Maastricht, Netherlands, 6202 | |
South Africa | |
University of Cape Town | |
Cape Town, South Africa |
Principal Investigator: | Robert D Galiano, MD | Northwestern University Feinberg School of Medicine |
Responsible Party: | Smith & Nephew Wound Management Inc |
ClinicalTrials.gov Identifier: | NCT01640366 History of Changes |
Other Study ID Numbers: |
CE/US/11/01/PIC |
First Posted: | July 13, 2012 Key Record Dates |
Last Update Posted: | January 11, 2016 |
Last Verified: | January 2016 |
Keywords provided by Smith & Nephew Wound Management Inc:
surgical incision reduction mammoplasty healing complications negative pressure wound therapy |
Additional relevant MeSH terms:
Surgical Wound Wounds and Injuries |