The aim of this study is to assess the safety and clinical performance (both for patient and doctors) of the PICO 7Y system in delivering NPWT simultaneously to two closed incisions following bilateral oncoplastic breast surgery.
ID
Source
Brief title
Condition
- Breast therapeutic procedures
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
To assess clinical performance and safety 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
including the rate of leakage.
Secondary outcome
To assess the clinical performance and safety of the PICO 7Y NPWT system within
30 days of surgery, the following evidence is taken into account:
* The rate of successful wound healing at 14 and 30 days of surgery. The wound
healing is successful if there are no signs of surgical site complications
(SSC) such as persistent exudate, dehiscence, necrosis, seroma, hematoma or
infection.
* The incidence of SSC including infection, dehiscence or delayed wound healing
at day 14 and day 30. Please note delayed wound healing is healing that takes
longer than 10 days.
* The visual appearance rating of quality of wound closure. Healing rates will
be considered overall and separately for the oncologic side and the
contralateral side (this is because the risks are different).
* The pain experienced by the subject during the use of the PICO 7Y NPWT
system.
* The dressing wear time (time in days) and the number of dressings used per
surgical site.
* To evaluate change in health related quality of life, associated with
treatment, measured using change of the EQ-5D 5L scores from baseline to Day 7
and Day 30.
Exploratory
* To assess clinician acceptability of PICO 7Y dressing at 7 days, and
clinician satisfaction with the outcome at 30 days.
* To assess patient acceptability of PICO 7Y dressing at 7 days.
* To assess ease of application & removal of the PICO 7Y dressing.
* To assess patient comfort during wear.
Safety
* Analysis of adverse events experienced by subjects over a 30-day follow-up
period.
* Device-related adverse events and device deficiencies (quality issues) during
the period subjects receive NPWT therapy with PICO 7Y.
Background summary
Negative pressure wound therapy (NPWT) becomes more popular as a post-operative
dressing for closed surgical incisions. In current literature NPWT use on
general surgical closed incisions has been reported to reduce surgical site
complications including infection, dehiscence and delayed healing. The PICO
pump is canister-free, disposable and a single use NPWT device which generates
an effective nominal negative pressure of -80 mmHg and provides therapy during
seven days after surgery. Although some evidence exists which supports the
positive effects of NPWT in oncoplastic breast surgery closed incisions wounds,
there is no evidence in relation to single-use systems treating both wounds
simultaneously. PICO 7Y is a new variant of the already existing PICO system.
It has the ability to deliver negative pressure simultaneously across two wound
beds or closed incisions and their surrounding area instead of just one wound.
Previous studies have focused on NPWT systems with the ability to only supply
negative pressure to a single wound. The technical applications of the systems
are comparable, but the application of this Y-connection system may represent a
possible cost saving solution to the current PICO system in bilateral wounds.
Study objective
The aim of this study is to assess the safety and clinical performance (both
for patient and doctors) of the PICO 7Y system in delivering NPWT
simultaneously to two closed incisions following bilateral oncoplastic breast
surgery.
Study design
The study will comprise a prospective, open-labelled, multicenter study to
evaluate the use of the PICO 7Y system in closed incision NPWT during
oncoplastic breast surgery and contralateral reconstruction. Individual
participation in the study will last for 30 days (7 days treatment with the
PICO 7Y system with follow-up until day 30). The standard measurements
(questionnaire and pictures) will take place pre-operatively and at day 7, 14
end 30 post-operatively in the same hospital and will be performed by the same
doctors or nurses.
Study burden and risks
The risks to which the participants are exposed are neglectable for this
research. All dressings that are used for treatment of the patient are already
available on the market and have been used before for the treatment of patients
with similar unilateral operation wounds (PICO).
Potential advantages:
- Previous research with a precursor of the PICO-7Y system for breast
reductions has shown that fewer wound complications have occurred in the first
three post-operative weeks compared to a breast treated with only normal
dressings and without the PICO-system.
- The cosmetic aspect of the scar has shown better results in the first six
months after surgery with the PICO7Y system. However, this difference
disappeared after one year.
- This research will result in valuable information for the producer concerning
the efficiency, safety and patient satisfaction of the PICO7Y.
Potential disadvantages:
- The patient has to carry the pump that is connected to the dressings with her
all the time during the first 7 days after surgery. However, the pump is very
small and light weight and therefore it does not affect the mobilization of the
patient.
- Negative wound pressure could be experienced as uncomfortable. However
previous research showed a very high patient satisfaction for this aspect of
the wound system.
- The patient is obliged to additionally visit the clinic for two more times.
Moreover, the extra time needed filling out the questionnaires has to be
considered.
- In rare situations the patient might be hypersensitive or allergic to the
dressing which can cause redness, pain, a burning or itchy feeling, blistering
or peeling off the skin. If so, the dressings will be removed and the doctors
will decide on an alternative dressing or treatment.
- The PICO7Y pump contains a magnet. This implies the pump must be kept away
from any other medical devices such as pacemakers, defibrillators,
neurostimulators, cochlear implants, insulin pumps or other life supporting
equipment for at least 10cm.
Hessle Road 101
Hull HU3 2BN
GB
Hessle Road 101
Hull HU3 2BN
GB
Listed location countries
Age
Inclusion criteria
1. The subject must have understood and provided written informed consent
2. Female subjects who must be at least eighteen (18) years of age.
3. Willing and able to make all required study visits.
4. Able to follow instructions.
5. 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.
6. Subjects whose incisions will fit comfortably within the area of the pad of
the dressing sizes provided.
Exclusion criteria
1. 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.
2. 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.
3. 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.
4. Subjects with a local infection, close or at the site of the incision, at
the time of surgery
5. Subjects with incisions that are actively bleeding unless haemostasis has
been achieved.
6. Subjects with a genetic or acquired disease capable of negatively impact the
closed incision healing.
7. Subjects with a history of poor compliance with medical treatment.
8. Subjects who have participated previously in this clinical trial.
9. Subjects with a medical or physical condition that, in the opinion of
the Investigator, would preclude safe subject participation in the study.
10. Individuals from vulnerable populations including pregnant women and adult
females over 75 years.
11. Subjects who have received neo adjuvant chemotherapy within the last 30
days prior to surgery.
12. Patients who at the end of the surgery have only one breast operated.
Design
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL71191.096.19 |