PICO Breast Reduction Clinical Study Looking at Incision Healing Complications

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

View full results

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

200 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-06-30

Study Completion Date

2014-07-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Effect of the Negative Pressure Therapy Dressing Compared With Hydrogel Dressing.

NCT04265612

Wound Infection, Surgical

TERMINATED NA

A Comparative Study to Assess the Prevention of Surgical Site Infection (SSI's) in Revision Total Joint Arthroplasty Patients Treated With Single-Use Negative Pressure Wound Therapy (PICO™) or Standard Care Dressings (AQUACEL® Ag SURGICAL Dressing)

NCT02664168

Surgical Wound Infection

UNKNOWN NA

Nitropaste in Breast Reduction

NCT04321967

Gynecomastia Delayed Wound Healing

WITHDRAWN PHASE3

Force Modulating Tissue Bridges for Closure of Vertical Scars in Breast Reduction

NCT05028816

Surgical Incision

COMPLETED NA

NovoX®Cup as Primary Dressing After Breast Reduction

NCT06420323

Wound Healing Disorder Post-Surgical Complication Mammaplasty

RECRUITING

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Delayed Healing

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

PICO negative pressure

Single-use Negative Pressure Wound Therapy

Group Type EXPERIMENTAL

PICO

Intervention Type DEVICE

Single-use Negative Pressure Wound Therapy System

Standard of care dressing arm

Sterile gauze adhesive strips

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

PICO

Single-use Negative Pressure Wound Therapy System

Intervention Type DEVICE

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

Disposable NPWT

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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

Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No