Performance, Safety and Efficacy of NPWT Device

NCT04102865 | Completed Results

• 1 other identifier: CT1705POB
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 8

Brief Summary

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

Conditions

Wound Healing and Prevention

Keywords

surgical complication; Negative-Pressure Wound Therapy (NPWT); negative pressure; knee arthroplasty; abdominal incision

Outcome Measures

Primary Outcomes (3)

• Negative Pressure Maintenance at Nominal 80 mmHg

  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.

  30 days post-op

• Dressing Wear Time

  Dressing wear time in days as assessed of any unplanned dressing change by Abdominal and Knee surgery type.

  7 days

• Exudate Management (Occurrence of Exudate Leaks)

  Number of participants with occurrence of exudate leaks. Leakage classified as 'Any Leak' (Yes/No) by Abdominal and Knee surgery type.

  7 days

Secondary Outcomes (8)

• Incidence of Surgical Site Infection (SSI)

  30 days

• Incidence of Surgical Site Complications (SSC)

  30 days

• Condition of Peri-Wound Skin Assessed Through Visual Inspection

  Baseline, 7 days, 14 days, and 30 days

• 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

• Wound and Skin Visual Analog Scale (VAS) Score Assessment

  7 days, 14 days, and 30 days

Study Arms (2)

Abdominal

OTHER

Abdominal surgery type with investigational single use NPWT dressing

Device: Negative-Pressure Wound Therapy (NPWT)

Knee

OTHER

Knee surgery type with investigational single use NPWT dressing

Device: Negative-Pressure Wound Therapy (NPWT)

Interventions

Negative-Pressure Wound Therapy (NPWT) DEVICE

Investigational 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 7 days.

Also known as: NPWT system

Abdominal; Knee

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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 .

You may not qualify if:

• 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.

Sponsors & Collaborators

• Smith & Nephew, Inc.: lead

Study Sites (8)

Worthing Hospital

Worthing, West Sussex, BN11 2DH, United Kingdom

Location

Queen Elizabeth Hospital

Birmingham, United Kingdom

Location

Western General Hospital

Edinburgh, EH4 2XU, United Kingdom

Location

Queen Elizabeth the Queen Mother Hospital

Margate, United Kingdom

Location

North Tyneside General Hospital

North Shields, United Kingdom

Location

RJAH Orthopaedic Hospital

Oswestry, United Kingdom

Location

Peterborough City Hospital

Peterborough, United Kingdom

Location

Torbay Hospital

Torquay, United Kingdom

Location

MeSH Terms

Interventions

Negative-Pressure Wound Therapy

Intervention Hierarchy (Ancestors)

Drainage; Therapeutics; Surgical Procedures, Operative; Wound Closure Techniques

Limitations and Caveats

The investigational single use NPWT dressing under investigation within this clinical study has not been submitted for approval and clearance as a medical device within any country

Results Point of Contact

• Title: Senior Manager Clinical Compliance
• Organization: Smith+Nephew, Inc

datasharing.gcs@smith-nephew.com

+44 7811 407089

Study Officials

• Steven Jeffery

  Queen Elizabeth Hospital, Birmingham, UK

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 26, 2018
• First Posted: September 25, 2019
• Study Start: July 12, 2019
• Primary Completion: July 6, 2022
• Study Completion: July 27, 2022
• Last Updated: December 11, 2024
• Results First Posted: November 21, 2024

Record last verified: 2022-12

Locations

GB (8)