Oncoplastic Breast SurgeryPICO7YNCT03835845
A Clinical Study to Assess the Safety and Clinical Performance of a New Dressing (PICO7Y) in Breast Surgery Patients
A study testing PICO7Y in people with Oncoplastic Breast Surgery and Bilateral Surgery, run by Smith & Nephew, Inc. at 5 sites in 2 countries.
Trial summary
The purpose of the study is to assess the use of a wound dressing system called PICO7Y following a two-sided breast surgery. PICO7Y is a new dressing system made to treat two incisions/wounds at the same time, and the purpose of this study is to check how the dressing is working by looking at data on how well the… Read more about this study
- Who is it for?
- Ages 18 to 75 years, women only
- Conditions the study is for
- Oncoplastic Breast Surgery, Bilateral Surgery
- What is being tested?
- PICO7Y
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 5 sitesin 2 countries
- Study dates
- 8 Mar 2019to 29 Feb 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 to 75 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- The subject must have understood and provided written informed consent (reference section 9.1)
- Female subjects who must be at least eighteen (18) years of age.
- Willing and able to make all required study visits.
- Able to follow instructions.
- Subjects must be undergoing, at the same time, both an oncoplastic breast surgery and a symmetrising breast reduction on the contralateral breast and have closed incisions that would benefit from NPWT.
- Subjects whose incisions will fit comfortably within the area of the pad of the dressing sizes provided.
Who cannot join
- Contraindications (per the PICO 7Y IFU) or hypersensitivity to the use of the investigational product or their components (i.e., 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.
- Subjects with skin features (e.g. tattoos, skin colour, pre-existing scarring) which in the opinion of the Investigator, will interfere with the study assessments.
- Suspected or confirmed allergy to any of the components of the ancillary products should they be deemed required, e.g. in the case of SECURA No-sting barrier skin wipes for patients with fragile skin.
- Subjects with a local infection, close or at the site of the incision, at the time of surgery
- Subjects with incisions that are actively bleeding unless haemostasis has been achieved.
- Subjects with a genetic or acquired disease capable of negatively impact the closed incision healing.
Show all 12Show fewer
- Subjects with a history of poor compliance with medical treatment.
- Subjects who have participated previously in this clinical trial.
- Subjects with a medical or physical condition that, in the opinion of the Investigator, would preclude safe subject participation in the study.
- Individuals from vulnerable populations including pregnant women and adult females over 75 years.
- Subjects who have received adjuvant chemotherapy within the last 30 days prior to surgery.
- Patients who at the end of the surgery have only one breast operated.
Trial locations and contacts
5 sites in 2 countries.
5 sites in 2 countries
United Kingdom4 sites
Queen Elizabeth Hospital
Birmingham, B15 2TH
Royal Free Hospital
London, NW3 2QG
Whythenshawe Hospital
Manchester, M23 9LT
Nottingham Breast Institute
Nottingham, NG5 1PB
About this study
Official title: An Observational, Prospective Multicentre Clinical Study to Assess the Safety and Clinical Performance of a New Single-use Negative Pressure Wound Therapy System (PICO 7Y) for the Simultaneous Management of Bilateral Closed Incisions in Oncoplastic Breast Surgery Patients
The purpose of the study is to assess the use of a wound dressing system called PICO7Y following a two-sided breast surgery. PICO7Y is a new dressing system made to treat two incisions/wounds at the same time, and the purpose of this study is to check how the dressing is working by looking at data on how well the dressing performs while you wear it and to check if doctors and patients are happy with it.
PICO7Y is based on another dressing called PICO.
Read the detailed description
It is thought that Negative Pressure Wound Therapy may have numerous mechanisms of action when used to manage surgical incisions, including reducing oedema, stimulating perfusion and managing exudate. Post-operative oedema in the peri-wound tissue is thought to limit tissue perfusion and high levels of wound fluid loss have been correlated with increased risk of post-operative infection and dehiscence23. Application of NPWT to the closed wound has been reported to improve patient comfort through reduced dressing changes and to lessen the period during which post-operative fluid discharges from the incision. Xia et al (2014)24 demonstrated that in 20 patients with infected wounds, NPWT resulted in significantly increased blood flow in the wounds when compared to pre application levels. In a study by Young et al (2013)25 four patients with pressure ulcers had oedema and wound bed thickness assessed during follow-up. They demonstrated a rapid reduction of peri-wound tissue oedema over four days and a 20% increase in the thickness of the wound bed by seven days of therapy.
Risk factors such as smoking and obesity have shown to increase complications follow oncoplastic surgery26 and it is possible that such populations could benefit more from the application of the NPWT. Furthermore there are a number of bilateral or multi wound indications where provision of a single device with the Y connection may represent a cost saving to the healthcare system. However, ultimately the use of NPWT for oncoplastic breast surgery closed incisions will be judged on whether it can increase the healing success rate while minimising complications. Holt and Murphy (2015)27 assessed the use of PICO single use NPWT system when applied to 24 patients with closed incisions following therapeutic resection. The contralateral breast underwent simultaneous symmetrising breast reduction with standard care dressings applied allowing for direct comparison. Although the cohort was too small to draw meaningful statistical conclusions they noted a lower incidence of wound breakdown (4.2% vs. 16.7%) and shorter time to healing (10.7 days vs. 16.1 days) in the NPWT group. However, this difference was partly attributed to the more extensive and complex nature of the therapeutic surgery. Similarly in a category of patients undergoing breast surgery with primary wound closure, Pellino et al (2014)19 showed significantly lower surgical site events when treated with PICO.
- Conditions
- Oncoplastic Breast Surgery, Bilateral Surgery
- Being tested
- PICO7Y
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PICO7YDevice
The PICO 7Y pump maintains NPWT at -80 mmHg (nominal) to two wound surfaces simultaneously. Exudate is managed by the dressings through a combination of absorption and evaporation of moisture through the outer film. The PICO 7Y kit is intended to be used for up to 7 days on low exuding wounds. For moderately exuding wounds the system is intended to be used for up to 4 days without a dressing change. For 7 days use on moderately exuding wounds additional dressings will be supplied.
| Study group | Role | What they receive |
|---|---|---|
| PICO7Y | Experimental | PICO 7Y is a single-use NPWT System consisting of a small portable pump \& pump clip, 2 AA batteries, 2 large multisite dressings, 2 extension tubes and secondary fixation strips. Receives: Device: PICO7Y |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical performance PICO 7Y NPWT system within 7 days of surgery
To assess clinical performance of the PICO 7Y NPWT system through its capacity to deliver negative pressure consistently at -80 mmHg, to both the reconstructed breast and the contralateral breast, during a period of 7 days. This will be measured by assessing the incision wound on Day 7, using CDC wound assessment criteria. Photographs will also be taken of the incision wound with treatment and after treatment.
Measured: within 7 days of surgery
Clinical performance PICO 7Y NPWT system
To assess clinical performance of the PICO 7Y NPWT system through its capacity to deliver negative pressure consistently at -80 mmHg, to both the reconstructed breast and the contralateral breast, during a period of 7 days. This will be measured by assessing the incision wound on Day 14 using CDC wound assessment criteria. Photographs will also be taken of the incision wound with treatment and after treatment.
Measured: within 14 days of surgery
Clinical performance PICO 7Y NPWT system within 30 days of surgery
To assess clinical performance of the PICO 7Y NPWT system through its capacity to deliver negative pressure consistently at -80 mmHg, to both the reconstructed breast and the contralateral breast, during a period of 7 days. This will be measured by assessing the incision wound on Day 30, using CDC wound assessment criteria. Photographs will also be taken of the incision wound with treatment and after treatment.
Measured: within 30 days of surgery
Safety of the PICO7Y NPWT system through number of Adverse Events, Device Deficiencies and Serious Adverse Events.
Safety will be assessed by reporting any Adverse Events or Device deficiencies, and any Serious adverse events.
Measured: 1 year
Secondary outcomes (9)
Rate of successful healing at day 30
via photographs of the wound incision taken at Day 0, Day 14, and Day 30
Measured: up to Day 30
Clinician Acceptability
Assessed with the electronic Case Report Forms, questioning the clinician's acceptability of the device
Measured: 1 year
Patient Acceptability
Assessed with the electronic Case Report Forms, questioning the patient's acceptability of the device
Measured: 1 year
Ease of Application
Assessed with electronic Case Report Forms, questioning ease of application as well as questionnaires given to the participants.
Measured: 1 year
Comfort
Assessing patient comfort during wear by measuring the Visual Analogue Score at day 0 and day 7.
Measured: up to Day 7
Ease of Removal
Assessed with electronic Case Report forms, questioning ease of removal as well as questionnaire.
Measured: 1 year
Dressing Wear Time
Assessed with electronic Case Report Forms as well as patient-facing questionnaires.
Measured: 1 year
Incidence of Surgical Site Complications
This will be measured by assessing the incision wound with CDC criteria at Day 0 to Day 30.
Measured: up to Day 30
Evaluate change in health-related quality of life
Assessed by using EQ-5D 5L questionnaires at Day 0, Day 14 and Day 30.
Measured: up to Day 30
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Feb 2019
- Study start8 Mar 2019
- Primary completion29 Feb 2020
- Study completion29 Feb 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Oncoplastic Breast SurgeryStudies 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
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Smith & Nephew, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- John Murphy, MBChB, Principal investigator, Oncoplastic Breast SurgeonBrian Gilchrist, PhD, Study chair, Smith & Nephew - Global Clinical Strategy
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03835845
- Sponsor's protocol ID
- CT1704P7Y
- Acronym
- PICO7Y
- Status last verified
- Jun 2022
- First submitted
- 7 Jan 2019
- Last updated
- 21 Jun 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Observational, Prospective Multicentre Clinical Study to Assess the Safety and Clinical Performance of a New Single-use Negative Pressure Wound Therapy System (PICO 7Y) for the Simultaneous Management of Bilateral Closed Incisions in Oncoplastic Breast Surgery Patients
- ClinicalTrials.gov ID
- NCT03835845
- Acronym / sponsor ID
- PICO7Y / CT1704P7Y
- Conditions
- Oncoplastic Breast Surgery, Bilateral Surgery
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Smith & Nephew, Inc.Industry (pharma, biotech, devices)
- Study start
- 8 Mar 2019 (actual)
- Primary completion
- 29 Feb 2020 (actual)
- Study completion
- 29 Feb 2020 (actual)
- First posted
- 11 Feb 2019 (actual)
- Results
- Not posted in the source record
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 the study is to assess the use of a wound dressing system called PICO7Y following a two-sided breast surgery. PICO7Y is a new dressing system made to treat two incisions/wounds at the same time, and the purpose of this study is to check how the dressing is working by looking at data on how well the dressing performs while you wear it and to check if doctors and patients are happy with it.
PICO7Y is based on another dressing called PICO.
Detailed description
It is thought that Negative Pressure Wound Therapy may have numerous mechanisms of action when used to manage surgical incisions, including reducing oedema, stimulating perfusion and managing exudate. Post-operative oedema in the peri-wound tissue is thought to limit tissue perfusion and high levels of wound fluid loss have been correlated with increased risk of post-operative infection and dehiscence23. Application of NPWT to the closed wound has been reported to improve patient comfort through reduced dressing changes and to lessen the period during which post-operative fluid discharges from the incision. Xia et al (2014)24 demonstrated that in 20 patients with infected wounds, NPWT resulted in significantly increased blood flow in the wounds when compared to pre application levels. In a study by Young et al (2013)25 four patients with pressure ulcers had oedema and wound bed thickness assessed during follow-up. They demonstrated a rapid reduction of peri-wound tissue oedema over four days and a 20% increase in the thickness of the wound bed by seven days of therapy.
Risk factors such as smoking and obesity have shown to increase complications follow oncoplastic surgery26 and it is possible that such populations could benefit more from the application of the NPWT. Furthermore there are a number of bilateral or multi wound indications where provision of a single device with the Y connection may represent a cost saving to the healthcare system. However, ultimately the use of NPWT for oncoplastic breast surgery closed incisions will be judged on whether it can increase the healing success rate while minimising complications. Holt and Murphy (2015)27 assessed the use of PICO single use NPWT system when applied to 24 patients with closed incisions following therapeutic resection. The contralateral breast underwent simultaneous symmetrising breast reduction with standard care dressings applied allowing for direct comparison. Although the cohort was too small to draw meaningful statistical conclusions they noted a lower incidence of wound breakdown (4.2% vs. 16.7%) and shorter time to healing (10.7 days vs. 16.1 days) in the NPWT group. However, this difference was partly attributed to the more extensive and complex nature of the therapeutic surgery. Similarly in a category of patients undergoing breast surgery with primary wound closure, Pellino et al (2014)19 showed significantly lower surgical site events when treated with PICO.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| PICO7Y | Experimental | Device: PICO7YPICO 7Y is a single-use NPWT System consisting of a small portable pump \& pump clip, 2 AA batteries, 2 large multisite dressings, 2 extension tubes and secondary fixation strips. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- The subject must have understood and provided written informed consent (reference section 9.1)
- Female subjects who must be at least eighteen (18) years of age.
- Willing and able to make all required study visits.
- Able to follow instructions.
- Subjects must be undergoing, at the same time, both an oncoplastic breast surgery and a symmetrising breast reduction on the contralateral breast and have closed incisions that would benefit from NPWT.
Key exclusion criteria (12 listed)
- Contraindications (per the PICO 7Y IFU) or hypersensitivity to the use of the investigational product or their components (i.e., 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.
- Subjects with skin features (e.g. tattoos, skin colour, pre-existing scarring) which in the opinion of the Investigator, will interfere with the study assessments.
- Suspected or confirmed allergy to any of the components of the ancillary products should they be deemed required, e.g. in the case of SECURA No-sting barrier skin wipes for patients with fragile skin.
- Subjects with a local infection, close or at the site of the incision, at the time of surgery
- Subjects with incisions that are actively bleeding unless haemostasis has been achieved.
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 |
|---|---|---|
| PICO7YThe PICO 7Y pump maintains NPWT at -80 mmHg (nominal) to two wound surfaces simultaneously. Exudate is managed by the dressings through a combination of absorption and evaporation of moisture through the outer film. The PICO 7Y kit is intended to be used for up to 7 days on low exuding wounds. For moderately exuding wounds the system is intended to be used for up to 4 days without a dressing change. For 7 days use on moderately exuding wounds additional dressings will be supplied. | Device | PICO7Y |
Primary outcome
Clinical performance PICO 7Y NPWT system within 7 days of surgery
Time frame: within 7 days of surgery
To assess clinical performance of the PICO 7Y NPWT system through its capacity to deliver negative pressure consistently at -80 mmHg, to both the reconstructed breast and the contralateral breast, during a period of 7 days. This will be measured by assessing the incision wound on Day 7, using CDC wound assessment criteria. Photographs will also be taken of the incision wound with treatment and after treatment.
Clinical performance PICO 7Y NPWT system
Time frame: within 14 days of surgery
To assess clinical performance of the PICO 7Y NPWT system through its capacity to deliver negative pressure consistently at -80 mmHg, to both the reconstructed breast and the contralateral breast, during a period of 7 days. This will be measured by assessing the incision wound on Day 14 using CDC wound assessment criteria. Photographs will also be taken of the incision wound with treatment and after treatment.
Clinical performance PICO 7Y NPWT system within 30 days of surgery
Time frame: within 30 days of surgery
To assess clinical performance of the PICO 7Y NPWT system through its capacity to deliver negative pressure consistently at -80 mmHg, to both the reconstructed breast and the contralateral breast, during a period of 7 days. This will be measured by assessing the incision wound on Day 30, using CDC wound assessment criteria. Photographs will also be taken of the incision wound with treatment and after treatment.
Safety of the PICO7Y NPWT system through number of Adverse Events, Device Deficiencies and Serious Adverse Events.
Time frame: 1 year
Safety will be assessed by reporting any Adverse Events or Device deficiencies, and any Serious adverse events.
9 secondary outcomes
Rate of successful healing at day 30
Time frame: up to Day 30
Clinician Acceptability
Time frame: 1 year
Patient Acceptability
Time frame: 1 year
Ease of Application
Time frame: 1 year
Comfort
Time frame: up to Day 7
Ease of Removal
Time frame: 1 year
Dressing Wear Time
Time frame: 1 year
Incidence of Surgical Site Complications
Time frame: up to Day 30
Evaluate change in health-related quality of life
Time frame: up to Day 30
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jun 2022.
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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.
John Murphy, MBChB principal investigator
Oncoplastic Breast Surgeon
Brian Gilchrist, PhD study chair
Smith & Nephew - Global Clinical Strategy
5 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing PICO7Y in people with Oncoplastic Breast Surgery and Bilateral Surgery, run by Smith & Nephew, Inc. at 5 sites in 2 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 6 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 21 Jun 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in United Kingdom, Netherlands. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Clinical performance PICO 7Y NPWT system within 7 days of surgery (time frame: within 7 days of surgery). The study lists 4 primary outcomes in all. 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 21 Jun 2022.