Performance, Safety and Efficacy of PICO Device.

• ClinicalTrials.gov Identifier: NCT03698968
• Recruitment Status: Completed
• First Posted: October 9, 2018
• Last Update Posted: September 18, 2019
• Sponsor: Smith & Nephew, Inc.
• Information provided by (Responsible Party): Smith & Nephew, Inc.

Study Description

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

Condition or disease	Intervention/treatment	Phase
Wound Heal	Device: Negative Pressure Wound Therapy	Not Applicable

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.

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 50 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Masking Description: Open
• Primary Purpose: Prevention
• 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.
• Actual Study Start Date: November 6, 2018
• Actual Primary Completion Date: June 18, 2019
• Actual Study Completion Date: June 18, 2019

Arms and Interventions

Arm	Intervention/treatment
Single prospective intervention	Device: Negative Pressure Wound Therapy; Single use disposable negative pressure system. The system is capable of delivering up to 80 mm Hg negative pressure to a wound or surgical incision site and managing low to moderate levels of exudate or fluid generated by the wound or incision. The therapy may be administered for up to 1 week.

Outcome Measures

Primary Outcome Measures :

1. Functional clinical performance of the PICO 7 NPWT system through delivery of negative pressure [ Time Frame: 7 Days ]
   Negative pressure maintenance at nominal 80 mmHg as assessed as the average of the negative pressure values recorded by the device microchip
2. Functional clinical performance of the PICO 7 NPWT system through wound exudate management [ Time Frame: 7 Days ]
   Number of NPWT systems with no occurrence of exudate leaks as assessed through a combination of leakage alert data from device microchip and/or clinical data on any leakage observed during the dressing wearing period resulting or not, in an unplanned dressing change
3. Composite Clinical Success [ Time Frame: 7 Days ]

   Composite Clinical Success (CCS) defined as a binary variable (1/0) (1 if both of the following are true and 0 if at least one of the two is false):

   A. Nominal pressure is in the interval 80mmHg ± 7mmHg

   B. No leakage

Secondary Outcome Measures :

1. Number of participants with incidence of Surgical Site Infection (SSI) - Superficial, deep. [CDC criteria] [ Time Frame: 30 Days ]
   For incidence of SSI and incidence of SSC binary variables indicating presence of/absence of will be defined and the frequencies together with percentages reported/identified outcomes will be reported. Logistic models will be fitted and associated factors adjusted for if there is adequate data
2. Number of participants with incidence of Surgical Site Complications (SSC) - dehiscence (superficial/deep etc.), seroma, necrosis, hematoma, suture abscess [ Time Frame: 30 Days ]
   For incidence of SSI and incidence of SSC binary variables indicating presence of/absence of will be defined and the frequencies together with percentages reported/identified outcomes will be reported. Logistic models will be fitted and associated factors adjusted for if there is adequate data
3. Percentage of successful skin graft take or flap survival at Days 7, 14 and 30 [ Time Frame: 30 Days ]
   Assessed by clinician visual assessment
4. Visual inspection of peri-wound skin condition [ Time Frame: 30 Days ]
   Visual inspection assessment (e.g., healthy, fragile, inflamed, erythema, bruising, eczematous, dry/flaky, macerated) at 7, 14 and 30 days
5. Visual Analog Scale (VAS) - pain [ Time Frame: 30 Days ]
   Level of subject pain during wear of the PICO 7 system, at dressing removal and at application assessed by VAS scale (pain intensity as none, mild, moderate, or severe) following 7 day therapy
6. Dressing wear time in days [ Time Frame: 30 Days ]
   Assessed through a combination of data from device microchip and CRF recorded data of any unplanned dressing change

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Locations

Switzerland

Ospedale Regionale di Lugano; Sede Ospedale Italiano

Lugano, Switzerland

United Kingdom

Mid Essex Hospital Services

Chelmsford, Essex, United Kingdom, CM1 7ET

The Robert Jones & Agnes Hunt Orthopaedic Hospital NHS Foundation

Oswestry, Shropshire, United Kingdom, SY10 7AG

University Hospitals Birmingham NHS Foundation Trust

Birmingham, United Kingdom

Queen Victoria Hospital

East Grinstead, United Kingdom, RH19 3DZ

Manchester University NHS Foundation Trust

Manchester, United Kingdom

Queen Elizabeth the Queen Mother Hospital

Margate, United Kingdom

North Tyneside General Hospital

North Shields, United Kingdom

Norfolk & Norwich University Hospital

Norwich, United Kingdom, NR47UY

Peterborough City Hospital, North West Anglia NHS Foundation Trust

Peterborough, United Kingdom

Mid-Yorkshire NHS Trust

Wakefield, United Kingdom

Sponsors and Collaborators

Smith & Nephew, Inc.

Investigators

• Study Director: Rachael Winter; T.J. Smith & Nephew, LTD
• Principal Investigator: Sudheer Karlakki; Robert Jones & Agnes Hunt Orthopaedic Hospital

More Information

• Responsible Party: Smith & Nephew, Inc.
• ClinicalTrials.gov Identifier: NCT03698968
• Other Study ID Numbers: CT1703PC7
• First Posted: October 9, 2018
• Last Update Posted: September 18, 2019
• Last Verified: September 2019

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Smith & Nephew, Inc.:

surgical complication; NPWT; negative pressure; knee arthroplasty; abdominal incision; skin graft; infection; dehisced