Delayed HealingNCT01640366
PICO Breast Reduction Clinical Study Looking at Incision Healing Complications
A study testing PICO in people with Delayed Healing, run by Smith & Nephew, Inc. at 6 sites in 4 countries.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Delayed Healing
- What is being tested?
- PICO
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 6 sitesin 4 countries
- Study dates
- Jun 2012to Jul 2014
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 12Show fewer
- 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- Patients who have participated in this trial previously and who were withdrawn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
Trial locations and contacts
6 sites in 4 countries.
6 sites in 4 countries
United States3 sites
Northwestern University Feinberg School of Medicine
Chicago, Illinois, 60611
Cleveland Clinic
Cleveland, Ohio, 44195
Montefiore
The Bronx, New York, 10461
About this study
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
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.
Read the 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.
- Conditions
- Delayed Healing
- Being tested
- PICO
- Keywords
- surgical incision, reduction mammoplasty, healing complications, negative pressure wound therapy
- Medical subject headings
- Surgical Wound
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PICODevice
Also called Disposable NPWT
Single-use Negative Pressure Wound Therapy System
| Study group | Role | What they receive |
|---|---|---|
| PICO negative pressure | Experimental | Single-use Negative Pressure Wound Therapy Receives: Device: PICO |
| Standard of care dressing arm | No intervention | Sterile gauze adhesive strips |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 21 days postoperatively
Secondary outcomes (8)
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.
Measured: 21 days postoperatively
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.
Measured: 21 days postoperatively
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.
Measured: Within 7 days postoperatively
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.
Measured: Within 10 days postoperatively
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.
Measured: 90 days postoperatively
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.
Measured: 21 days postoperatively
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.
Measured: 21 days postoperatively
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.
Measured: 21 days postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jul 2012 (estimated)
- Study startJun 2012
- Primary completionApr 2014
- Study completionJul 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Delayed HealingStudies of the same condition, open and under way.
- More trials run by Smith & Nephew, Inc.The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 200 participants (actual)
Sponsor and investigators
- Lead sponsor
- Smith & Nephew, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Robert D Galiano, MD, Principal investigator, Northwestern University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01640366
- Sponsor's protocol ID
- CE/US/11/01/PIC
- Status last verified
- Feb 2020
- First submitted
- 3 Jul 2012
- Last updated
- 28 Feb 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01640366
- Acronym / sponsor ID
- CE/US/11/01/PIC
- Conditions
- Delayed Healing
- Keywords
- surgical incision, reduction mammoplasty, healing complications, negative pressure wound therapy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 200 participants (actual)
- Lead sponsor
- Smith & Nephew, Inc.Industry (pharma, biotech, devices)
- Study start
- Jun 2012
- Primary completion
- Apr 2014 (actual)
- Study completion
- Jul 2014 (actual)
- First posted
- 13 Jul 2012 (estimated)
- Results
- Posted 28 Feb 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| PICO negative pressure | Experimental | Device: PICOSingle-use Negative Pressure Wound Therapy |
| Standard of care dressing arm | No intervention | –Sterile gauze adhesive strips |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (12 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PICOAlso: Disposable NPWTSingle-use Negative Pressure Wound Therapy System | Device | PICO negative pressure |
Primary outcome
Number of Participants Experiencing Incision Healing Complications up to Day 21 Postoperatively
Time frame: 21 days 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.
8 secondary outcomes
Number of Participants Experiencing Postsurgical Incision Healing Complications (Dehiscence) Occurring up to Day 21 Postoperatively
Time frame: 21 days postoperatively
Number of Participants Experiencing Postsurgical Incision Healing Complications (Infection) Occurring up to Day 21 Postoperatively
Time frame: 21 days postoperatively
Number of Participants Experiencing Postsurgical Incision Healing Complications (Delayed Healing) Occurring Within 7 Days Postoperatively
Time frame: Within 7 days postoperatively
Number of Participants Experiencing Postsurgical Incision Healing Complications (Delayed Healing) Occurring Within 10 Days Postoperatively
Time frame: Within 10 days postoperatively
Aesthetic Appearance (Cosmesis) and Scar Quality at 90 Days Postoperatively
Time frame: 90 days postoperatively
Number of Skin, Nipple and Areola Necrosis Occurring up to and 21 Days Postoperatively
Time frame: 21 days postoperatively
Number of Hematoma's Occurring up to and 21 Days Postoperatively
Time frame: 21 days postoperatively
Number of Wounds Showing 100% Closure Occurring up to and 21 Days Postoperatively
Time frame: 21 days postoperatively
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Feb 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Robert D Galiano, MD principal investigator
Northwestern University
6 sites in 4 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing PICO in people with Delayed Healing, run by Smith & Nephew, Inc. at 6 sites in 4 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Feb 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in United States, France, Netherlands, South Africa. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 28 Feb 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants Experiencing Incision Healing Complications up to Day 21 Postoperatively (time frame: 21 days postoperatively). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Feb 2020.