Performance, Safety and Efficacy of NPWT Device

Study Overview
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Brief Summary
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Smith & Nephew are assessing a new single use NPWT system.

Detailed Description
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Smith & Nephew are assessing a new single use NPWT system.There is a significant amount of clinical evidence to show that NPWT may reduce oedema, increase healing and reduce chance of infection, through maintenance of pressure therapy, in closed incisions. The proposed clinical strategy is to conduct a study assessing performance and safety of the new single use NPWT system in order to assess whether the same benefits of other NPWT systems on the market can be applied to therapy provided with the new system. Subjects with abdominal incisions and knee incisions following knee surgery will be recruited to the study and receive NPWT for 7 days. The performance of the system will be logged by the device and acceptability of the device will be assessed by patient and clinician. Safety will be assessed with a 30 day follow up to assess complications and device related events.

Official Title
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NPWT Pre-registration Study: A Prospective, Multicentre Trial to Assess Performance, Safety and Efficacy of a Single-use NPWT Device

Conditions
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Wound Healing and Prevention

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 In Orthopaedic surgery: subject is scheduled for an elective primary knee replacement arthroplasty and ASA score of 2-3 (Phase 1 only) In Abdominal surgery: subject is scheduled for an elective open or laparoscopic gastrointestinal and/or gynaecological surgery with incision ≥5 cm and has an ASA score of 2-3. Immediately after the surgery, subject will have one suitable closed abdominal or knee surgery incision, (if there is more than one incision then the clinician should choose the one which in their opinion is most suited for PICO therapy) that fits under the absorbent dressing area of the appropriate PICO ONBOARD dressing sizes (dressing sizes equivalent to PICO dressings 10 x 20 cm, 10 x 30 cm, 10 x 40 cm, 15 x 20 cm, 15 x 30 cm). Exclusion Criteria: Contraindications (per the PICO ONBOARD IB) 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 similar clinical trial (wound care related) 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. Subjects attending for an operation at the same surgery site (anatomical location) within the last 3 months Subjects undergoing a procedure as part of palliative care (to be confirmed during surgery). Subjects where the Electronic Component area of the device would be placed on a load-bearing anatomical location (i.e. areas vulnerable to pressure damage). Subjects with incisions that are actively bleeding unless haemostasis has been achieved (to be confirmed during surgery). Subjects with infected skin lesions or incisions at the time of surgery (any area of the body). Subjects who have participated previously in this clinical trial Subjects with a history of poor compliance with medical treatment. Subjects with a BMI ≥ 40. 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 use NPWT dressing<br>single use NPWT dressing | 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 |
| --- | --- | --- |
| Efficacy of the NPWT system by working 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 | 
| Efficacy of the NPWT system by dressing wear time | Dressing wear time (7 days) as assessed through a combination of data from device microchip and CRF recorded data of any unplanned dressing change. | 7 days | 
| Efficacy of the NPWT system by exudate management | Exudate management assessed by 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 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of Surgical Site Infection (SSI) | Incidence of Surgical Site Infection (SSI) - Superficial, deep, organ [CDC criteria] within 30 days of surgery | 30 days | 
| Incidence of Surgical site Complications (SSC) | Incidence of Surgical site Complications (SSC) [as applicable: dehiscence (superficial/deep, partial/total), seroma, necrosis, hematoma, suture abscess] within 30 days of surgery | 30 days | 
| Wound and Skin VAS score assessment | Wound and Skin VAS score assessment at 7, 14 and 30 days | 30 days | 
| Condition of peri-wound skin and skin under the pump module assessed through visual inspection | Condition of peri-wound skin and skin under the pump module assessed through visual inspection at 7, 14 and 30 days. | 30 days | 
| Level of pain during wear of the PICO ONBOARD system, and at dressing removal assessed by VAS scale following 7 day therapy |  | 7 days | 
| Comparison of Wound and Skin VAS scores | Comparison of Wound and Skin VAS scores at days 7, 14 and 30 as assessed by the treating clinicians versus scores provided by the independent assessor. | 30 days | 
| Range of motion assessment (ROM) for the knee | Range of motion assessment (ROM) for the knee at pre-operative visit, post-operative visit, 7, 14 and 30 days. | 30 days | 
| Level of pain during dressing removal | Level of pain during dressing removal (VAS scale) - pain intensity as none, mild, moderate, or severe. | 30 days post-op | 

 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