Clinical trial NCT04102865: Performance, Safety and Efficacy of NPWT Device
Official title: NPWT Pre-registration Study: A Prospective, Multicentre Trial to Assess Performance, Safety and Efficacy of a Single-use NPWT Device
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Wound Healing and Prevention
Keywords: surgical complication
Negative-Pressure Wound Therapy (NPWT)
negative pressure
knee arthroplasty
abdominal incision
Lead sponsor: Smith & Nephew, Inc.
Sponsor class: INDUSTRY
First posted: 2019-09-25
Enrollment: 90
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

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.

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
* 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.

Primary outcomes:
measure: Negative Pressure Maintenance at Nominal 80 mmHg
timeFrame: 30 days post-op
measure: Dressing Wear Time
timeFrame: 7 days
measure: Exudate Management (Occurrence of Exudate Leaks)
timeFrame: 7 days
Secondary outcomes:
measure: Incidence of Surgical Site Infection (SSI)
timeFrame: 30 days
measure: Incidence of Surgical Site Complications (SSC)
timeFrame: 30 days
measure: Condition of Peri-Wound Skin Assessed Through Visual Inspection
timeFrame: Baseline, 7 days, 14 days, and 30 days
measure: Condition of Skin Under the Investigative Single Use Negative-Pressure Wound Therapy (NPWT) Dressing Assessed Through Visual Inspection
timeFrame: Baseline, 7 days, 14 days, and 30 days
measure: Wound and Skin Visual Analog Scale (VAS) Score Assessment
timeFrame: 7 days, 14 days, and 30 days
measure: Range of Motion Assessment (ROM) for the Knee
timeFrame: 30 days
measure: Level of Pain During Wear of the Investigational Single Use Negative-Pressure Wound Therapy (NPWT) Dressing Assessed by VAS Score
timeFrame: 4 days and 7 days
measure: Level of Pain at Dressing Removal of the Investigative Single Use Negative-Pressure Wound Therapy (NPWT) Dressing Assessed by VAS Score
timeFrame: 7 days
Other outcomes:
Locations:
city: Worthing
country: United Kingdom
facility: Worthing Hospital
state: West Sussex
city: Birmingham
country: United Kingdom
facility: Queen Elizabeth Hospital
city: Edinburgh
country: United Kingdom
facility: Western General Hospital
city: Margate
country: United Kingdom
facility: Queen Elizabeth the Queen Mother Hospital
city: North Shields
country: United Kingdom
facility: North Tyneside General Hospital
city: Oswestry
country: United Kingdom
facility: RJAH Orthopaedic Hospital
city: Peterborough
country: United Kingdom
facility: Peterborough City Hospital
city: Torquay
country: United Kingdom
facility: Torbay Hospital
Study officials:
affiliation: Queen Elizabeth Hospital, Birmingham, UK
name: Steven Jeffery
role: PRINCIPAL_INVESTIGATOR
References: