Clinical trial NCT03698968: Performance, Safety and Efficacy of PICO Device.
Official title: A Prospective Follow up Study to Assess Performance, Safety and Efficacy of the PICO 7 NPWT System for Surgically Closed Incision Sites and Skin Grafts.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Wound Heal
Keywords: surgical complication
NPWT
negative pressure
knee arthroplasty
abdominal incision
skin graft
infection
dehisced
Lead sponsor: Smith & Nephew, Inc.
Sponsor class: INDUSTRY
First posted: 2018-10-09
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief summary: The study is being conducted to evaluate the safe and effective use of the PICO 7 system in surgically closed incision sites and wounds requiring closure by skin graft or flap as part of the PMCF plan for this product, for the purpose of continuing CE (Conformité Européene) Mark approval in accordance with MEDDEV 2.12-2

Detailed description: Although evidence exists which supports the positive effects of NPWT on take of skin grafts and flaps, there is limited evidence in relation to single-use systems such as PICO. Most previous studies have used traditional NPWT systems as part of their design. Though the technical applications of the traditional and newer single-use systems are comparable it is possible that some of the features of the latter may influence clinical outcomes. In addition to the limitations highlighted above, the cited studies have seldom assessed the ease of management and acceptability of NPWT systems. Although clinical outcomes may be considered paramount, these usability factors could also play a key role in ensuring compliance with negative pressure protocols.

Although evidence exists which supports the positive effects of NPWT on take of skin grafts and flaps, there is limited evidence in relation to single-use systems such as PICO. Most previous studies have used traditional NPWT systems as part of their design. Though the technical applications of the traditional and newer single-use systems are comparable it is possible that some of the features of the latter may influence clinical outcomes. In addition to the limitations highlighted above, the cited studies have seldom assessed the ease of management and acceptability of NPWT systems. Although clinical outcomes may be considered paramount, these usability factors could also play a key role in ensuring compliance with negative pressure protocols.

The study is being conducted to evaluate the safe and effective use of the PICO 7 system in surgically closed incision sites and wounds requiring closure by skin graft or flap as part of the PMCF plan for this product, for the purpose of continuing CE (Conformité Européene) Mark approval in accordance with MEDDEV 2.12-2.

The PICO system has recently been updated with minor modifications that make the system silent during wear. S \& N also wish to collect PMCF data in the indications of knee and abdominal incisions in order to make retrospective comparisons with data previously collected for these indications.

The aim of this study is therefore to assess whether the PICO 7 system is a safe and effective therapy for surgically closed incisions, skin grafts and flaps. Effectiveness will be defined by the ability of the system to deliver negative pressure and handle exudate and by percentage of successful skin graft or flap survival at Day 14.

A summary of known and potential risks and benefits to humans of each test article can be found in the Instructions for Use of PICO 7.

Eligibility criteria: Inclusion Criteria:

* The subject must provide written informed consent
* Subjects eighteen (18) years of age or older.
* Willing and able to make all required study visits.
* Able to follow instructions.
* Subject is suitable to participate in the study in the opinion of the Investigator
* Subject has a suitable, closed abdominal or knee surgery incision skin flap or skin graft (STSG, meshed or non-meshed) (if there is more than one incision then the clinician should choose the one which in their opinion is most suited to PICO therapy), that fits under the absorbent dressing area of the appropriate PICO 7 dressing supplied.

Exclusion Criteria:

* Contraindications (per the PICO 7 IFU) or hypersensitivity to the use of the investigational product or their components (e.g. silicone adhesives and polyurethane films \[direct contact with incision\], acrylic adhesives \[direct contact with skin\], polyethylene fabrics and super-absorbent powders \[polyacrylates\]) within the dressing).
* Subjects with extremely fragile skin who require the use of SECURA non-sting barrier skin wipes and have hypersensitivity to the ingredients in the wipes
* Participation in the treatment period of another clinical trial within thirty (30) days of operative visit or during the study.
* 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.
* Patients undergoing a procedure as part of palliative care (to be confirmed during surgery).
* Subjects with incisions or skin grafts that are actively bleeding unless haemostasis has been achieved (to be confirmed during surgery).
* Subjects with infected skin grafts or incisions at the time of surgery (except for those with perforated bowel or peritonitis).
* Subjects who have participated previously in this clinical trial
* Subjects with a history of poor compliance with medical treatment.
* Subjects with skin grafts to correct pressure ulcers where compression therapy is needed for healing (based on clinicians expertise).
* Subjects with a medical or physical condition that, in the opinion of the Investigator, would preclude safe subject participation in the study.

Primary outcomes:
measure: Functional clinical performance of the PICO 7 NPWT system through delivery of negative pressure
timeFrame: 7 Days
measure: Functional clinical performance of the PICO 7 NPWT system through wound exudate management
timeFrame: 7 Days
measure: Composite Clinical Success
timeFrame: 7 Days
Secondary outcomes:
measure: Number of participants with incidence of Surgical Site Infection (SSI) - Superficial, deep. [CDC criteria]
timeFrame: 30 Days
measure: Number of participants with incidence of Surgical Site Complications (SSC) - dehiscence (superficial/deep etc.), seroma, necrosis, hematoma, suture abscess
timeFrame: 30 Days
measure: Percentage of successful skin graft take or flap survival at Days 7, 14 and 30
timeFrame: 30 Days
measure: Visual inspection of peri-wound skin condition
timeFrame: 30 Days
measure: Visual Analog Scale (VAS) - pain
timeFrame: 30 Days
measure: Dressing wear time in days
timeFrame: 30 Days
Other outcomes:
Locations:
city: Lugano
country: Switzerland
facility: Ospedale Regionale di Lugano; Sede Ospedale Italiano
city: Chelmsford
country: United Kingdom
facility: Mid Essex Hospital Services
state: Essex
city: Oswestry
country: United Kingdom
facility: The Robert Jones & Agnes Hunt Orthopaedic Hospital NHS Foundation
state: Shropshire
city: Birmingham
country: United Kingdom
facility: University Hospitals Birmingham NHS Foundation Trust
city: East Grinstead
country: United Kingdom
facility: Queen Victoria Hospital
city: Manchester
country: United Kingdom
facility: Manchester University NHS Foundation Trust
city: Margate
country: United Kingdom
facility: Queen Elizabeth the Queen Mother Hospital
city: North Shields
country: United Kingdom
facility: North Tyneside General Hospital
city: Norwich
country: United Kingdom
facility: Norfolk & Norwich University Hospital
city: Peterborough
country: United Kingdom
facility: Peterborough City Hospital, North West Anglia NHS Foundation Trust
city: Wakefield
country: United Kingdom
facility: Mid-Yorkshire NHS Trust
Study officials:
affiliation: T.J. Smith & Nephew, LTD
name: Rachael Winter
role: STUDY_DIRECTOR
affiliation: Robert Jones & Agnes Hunt Orthopaedic Hospital
name: Sudheer Karlakki
role: PRINCIPAL_INVESTIGATOR
References: