Performance, Safety and Efficacy of PICO Device.

Study Overview
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Brief Summary
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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
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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.

Official Title
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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.

Conditions
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Wound Heal

Intervention / Treatment
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* Device: Negative Pressure Wound Therapy


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Single prospective intervention<br> | Device: Negative Pressure Wound Therapy<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Functional clinical performance of the PICO 7 NPWT system through delivery of negative pressure | Negative pressure maintenance at nominal 80 mmHg as assessed as the average of the negative pressure values recorded by the device microchip | 7 Days | 
| Functional clinical performance of the PICO 7 NPWT system through wound exudate management | 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 | 7 Days | 
| Composite Clinical Success | 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 | 7 Days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of participants with incidence of Surgical Site Infection (SSI) - Superficial, deep. [CDC criteria] | 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 | 30 Days | 
| Number of participants with incidence of Surgical Site Complications (SSC) - dehiscence (superficial/deep etc.), seroma, necrosis, hematoma, suture abscess | 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 | 30 Days | 
| Percentage of successful skin graft take or flap survival at Days 7, 14 and 30 | Assessed by clinician visual assessment | 30 Days | 
| Visual inspection of peri-wound skin condition | Visual inspection assessment (e.g., healthy, fragile, inflamed, erythema, bruising, eczematous, dry/flaky, macerated) at 7, 14 and 30 days | 30 Days | 
| Visual Analog Scale (VAS) - pain | 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 | 30 Days | 
| Dressing wear time in days | Assessed through a combination of data from device microchip and CRF recorded data of any unplanned dressing change | 30 Days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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surgical complication, NPWT, negative pressure, knee arthroplasty, abdominal incision, skin graft, infection, dehisced