Performance, Safety and Efficacy of NPWT Device

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

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

Study Overview

• Status: Completed
• Conditions: Wound Healing and Prevention
• Intervention / Treatment: Device: Negative-Pressure Wound Therapy (NPWT)

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.

• Study Type: Interventional
• Enrollment (Actual): 90
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United Kingdom
  • Birmingham, United Kingdom
    • Queen Elizabeth Hospital
  • Edinburgh, United Kingdom, EH4 2XU
    • Western General Hospital
  • Margate, United Kingdom
    • Queen Elizabeth the Queen Mother Hospital
  • North Shields, United Kingdom
    • North Tyneside General Hospital
  • Oswestry, United Kingdom
    • RJAH Orthopaedic Hospital
  • Peterborough, United Kingdom
    • Peterborough City Hospital
  • Torquay, United Kingdom
    • Torbay Hospital
  • West Sussex
    • Worthing, West Sussex, United Kingdom, BN11 2DH
      • Worthing Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Non-Randomized
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Abdominal; Abdominal surgery type with investigational single use NPWT dressing	Device: Negative-Pressure Wound Therapy (NPWT); 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.; Other Names: NPWT system
Other: Knee; Knee surgery type with investigational single use NPWT dressing	Device: Negative-Pressure Wound Therapy (NPWT); 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.; Other Names: NPWT system

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence of Surgical Site Infection (SSI)	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	30 days
Incidence of Surgical Site Complications (SSC)	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	30 days
Condition of Peri-Wound Skin Assessed Through Visual Inspection	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	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	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	Baseline, 7 days, 14 days, and 30 days
Wound and Skin Visual Analog Scale (VAS) Score Assessment	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).	7 days, 14 days, and 30 days
Range of Motion Assessment (ROM) for the Knee	Range of Motion (ROM) assessment for the knee at pre-operative visit, post-operative visit, 7, 14 and 30 days.	30 days
Level of Pain During Wear of the Investigational Single Use Negative-Pressure Wound Therapy (NPWT) Dressing Assessed by VAS Score	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.	4 days and 7 days
Level of Pain at Dressing Removal of the Investigative Single Use Negative-Pressure Wound Therapy (NPWT) Dressing Assessed by VAS Score	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.	7 days

Collaborators and Investigators

• Sponsor: Smith & Nephew, Inc.
• Investigators: Principal Investigator: Steven Jeffery, Queen Elizabeth Hospital, Birmingham, UK

Study record dates

Study Major Dates

• Study Start (Actual): July 12, 2019
• Primary Completion (Actual): July 6, 2022
• Study Completion (Actual): July 27, 2022

Study Registration Dates

• First Submitted: April 26, 2018
• First Submitted That Met QC Criteria: September 23, 2019
• First Posted (Actual): September 25, 2019

Study Record Updates

• Last Update Posted (Estimated): December 11, 2024
• Last Update Submitted That Met QC Criteria: November 22, 2024
• Last Verified: December 1, 2022

More Information

Terms related to this study

• Keywords: knee arthroplasty; negative pressure; surgical complication; abdominal incision; Negative-Pressure Wound Therapy (NPWT)
• Other Study ID Numbers: CT1705POB

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No