Performance, Safety and Efficacy of NPWT Device

Not Applicable

Completed

Conditions: Wound Healing and Prevention

Interventions: Device: Negative Pressure Wound Therapy

Registration Number: NCT04102865

Lead Sponsor: Smith & Nephew, Inc.

Brief Summary: Smith \& Nephew are assessing a new investigational single use NPWT system.

Detailed Description: Smith \& Nephew are assessing a new investigational 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. 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.

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 90

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 American Society of Anesthesiologists (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 Negative Pressure Wound Therapy) that fits under the absorbent dressing area of the appropriate Negative Pressure dressing sizes .

Exclusion Criteria

Contraindications (per the Investigator Brochure) 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 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.

Study & Design

Study Type: INTERVENTIONAL

Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
single use NPWT dressing	Negative Pressure Wound Therapy	single use NPWT dressing

Primary Outcome Measures

Name	Time	Method
Negative Pressure Maintenance at Nominal 80 mmHg	30 days post-op	Negative pressure maintenance at nominal 80 mmHg assessed as the average of the negative pressure values recorded by the device for Abdominal and Knee surgery types. This data was summarized to show an average negative pressure provided over the treatment duration.
Dressing Wear Time	7 days	Dressing wear time in days as assessed of any unplanned dressing change by Abdominal and Knee surgery type.
Exudate Management (Occurrence of Exudate Leaks)	7 days	Number of participants with occurrence of exudate leaks. Leakage classified as 'Any Leak' (Yes/No) by Abdominal and Knee surgery type.

Secondary Outcome Measures

Name	Time	Method
Incidence of Surgical Site Infection (SSI)	30 days	Number of participants with incidence of Surgical Site Infection (SSI) within 30 days of surgery classified using Centers for Decease Control (CDC) criteria of: * Superficial Infection * Deep Infection * Organ Space Infection * Other
Incidence of Surgical Site Complications (SSC)	30 days	Number of participants with incidence of Surgical Site Complications (SSC) within 30 days of surgery categorized as: * Deep Dehiscence * Superficial Dehiscence * Partial Dehiscence * Total Dehiscence * Seroma * Necrosis * Hematoma * Suture Abscess * Other
Condition of Peri-Wound Skin Assessed Through Visual Inspection	Baseline, 7 days, 14 days, and 30 days	Condition of peri-wound skin assessed through visual inspection by the investigator at baseline, 7, 14, and 30 days. Number of participants by Abdominal and Knee surgery type where skin was categorized with any condition that applied (i.e., multiple selections possible) from the following criteria: * Healthy * Fragile * Inflamed * Erythema * Bruising * Eczematous * Dry and Flaky * Macerated * Other
Condition of Skin Under the Investigative Single Use Negative-Pressure Wound Therapy (NPWT) Dressing Assessed Through Visual Inspection	Baseline, 7 days, 14 days, and 30 days	Condition of skin under investigative single use Negative-Pressure Wound Therapy (NPWT) dressing assessed through visual inspection by the investigator at baseline, 7, 14, and 30 days. Number of participants by Abdominal and Knee surgery type where skin was categorized with any condition that applied (i.e., multiple selections possible) from the following criteria: * Healthy * Fragile * Inflamed * Erythema * Bruising * Eczematous * Dry and Flaky * Macerated * Other
Wound and Skin Visual Analog Scale (VAS) Score Assessment	7 days, 14 days, and 30 days	Wound and Skin VAS score assessment at 7, 14 and 30 days. Scores range from 0 to 100 with a low score associated to a wound with a major gapping, dehiscence, severe inflammation and/or infection (i.e., poor outcome); and a high correspond to a completely healed wound with no evidence for inflammation (i.e., excellent outcome).
Range of Motion Assessment (ROM) for the Knee	30 days	Range of Motion (ROM) assessment for the knee at pre-operative visit, post-operative visit, 7, 14 and 30 days.
Level of Pain During Wear of the Investigational Single Use Negative-Pressure Wound Therapy (NPWT) Dressing Assessed by VAS Score	4 days and 7 days	Level of pain during wear by investigational single use Negative-Pressure Wound Therapy (NPWT) Dressing at day 4 and day 7 assessed using a Visual Analog Scale (VAS) from 0 to 100 where a score of 0 indicated no pain and 100 indicated maximum pain.
Level of Pain at Dressing Removal of the Investigative Single Use Negative-Pressure Wound Therapy (NPWT) Dressing Assessed by VAS Score	7 days	Level of pain during dressing removal by Abdominal and Knee surgery type at treatment discontinuation (up to day 7) assessed using a Visual Analog Scale (VAS) from 0 to 100 where a score of 0 indicated no pain and 100 indicated maximum pain.

Trial Locations

Locations (8): Worthing Hospital
🇬🇧
Worthing, West Sussex, United Kingdom
Queen Elizabeth Hospital
🇬🇧
Birmingham, United Kingdom
Western General Hospital
🇬🇧
Edinburgh, United Kingdom
Queen Elizabeth the Queen Mother Hospital
🇬🇧
Margate, United Kingdom
North Tyneside General Hospital
🇬🇧
North Shields, United Kingdom
RJAH Orthopaedic Hospital
🇬🇧
Oswestry, United Kingdom
Peterborough City Hospital
🇬🇧
Peterborough, United Kingdom
Torbay Hospital
🇬🇧
Torquay, United Kingdom
Worthing Hospital
🇬🇧Worthing, West Sussex, United Kingdom