Single Center Clinical Study on New Negative Pressure Wound Therapy Dressing in the Management of Chronic & Acute Wounds

March 11, 2024 updated by: Smith & Nephew, Inc.

A Single Centre Clinical Evaluation of a New NPWT Dressing

The purpose of the study is to evaluate the clinical performance of a new Negative Pressure Wound Therapy dressing in the management of chronic and acute wounds.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

The primary objective is to evaluate the percentage of wounds progressing to healing at the end of the treatment period. The study will also evaluate the percentage of granulation tissue, pain experienced on dressing change and safety by way of incidence and nature of device-related or procedure-related Adverse Events and Device Deficiencies.

Study Type

Observational

Enrollment (Estimated)

23

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Canada
    • Ontario
      • London, Ontario, Canada, N6C 2R5
        • Lawson Health Research Institute
        • Contact:
        • Principal Investigator:
          • Adam Power

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Probability Sample

Study Population

This study aims to enroll up to 23 subjects from one clinical site in Canada with appropriate wound types including:

  • Chronic* (this may include DFUs, VLUs, Pressure Ulcers but this is not an exhaustive list)
  • Acute (this may include traumatic and dehisced surgical wounds and partial thickness burns, but this is not an exhaustive list) *Chronic wound in this study is defined as any wound of less than three months duration that is not healing after thirty (30) days of standard care and having addressed the underlying cause.

As this is a pilot study, there are no limits to inclusion of any one particular wound type, however a minimum of 5 acute and 5 chronic wounds is required.

Description

Inclusion Criteria:

  • Subject has provided written informed consent.
  • Subject is 18 years of age or over.
  • Subject is able and willing to comply with study requirements.
  • Subject is suitable to participate in the study in the opinion of the Investigator.
  • Subject is an inpatient at time of enrollment and will be able to attend follow-up visits in clinic following discharge.
  • Subject has a wound that, per Instructions for Use (IFU), is indicated and suitable for management with NPWT and fits one of the following wound types: a. Chronic* (this may include Diabetic Foot Ulcers (DFUs), Venous Leg Ulcers (VLUs), Pressure Ulcers but this is not an exhaustive list) b. Acute (this may include traumatic and dehisced surgical wounds and partial thickness burns) *Chronic wound in this study is defined as any wound of less than three months duration that is not healing after thirty (30) days of standard care and having addressed the underlying cause
  • Subject's wound to be treated is of a size that can be managed with one of the available sizes of the study device

Exclusion Criteria:

  • Subject has hypersensitivity to the use of the RENASYS NPWT System or its components, or a contraindication per the IFU such as: a. exposed arteries, veins, organs, or nerves b. necrotic tissue with eschar present (unless adequately debrided) c. non-enteric and unexplored fistulas d. exposed anastomotic site e. malignancy in the wound
  • Subject participation in the treatment period of another clinical trial within thirty (30) days of baseline visit or during the study.
  • Subject has skin features (e.g., tattoos, pre-existing scarring, etc.) which in the opinion of the investigator will interfere with the study assessments.
  • For lower extremity wounds, any subject with a wound on a limb with an Ankle Brachial Index (ABI) <0.7
  • Any subject that meets the definition of a Vulnerable Subject per ISO 14155 (i.e., individuals who are unable to fully understand all aspects of the investigation that are relevant to the decision to participate, or who could be manipulated or unduly influenced as a result of a compromised position, expectation of benefits or fear of retaliatory response). Ethnic minorities will be included providing they meet other inclusion criteria.
  • Subject has had the target wound for greater than three months.
  • Subject has a target wound that measures <3 millimeters (mm) in maximum depth.
  • Subject has untreated osteomyelitis
  • Subject has active, untreated soft tissue infection.
  • Subject has wounds that has previously been managed with NPWT in the previous four (4) weeks
  • Subject has participated previously in this clinical trial.
  • Subject has a history of poor compliance with medical treatment.
  • Pregnancy at time of enrolment.
  • Subject has a medical or physical condition that in the opinion of the Investigator would preclude safe subject participation in the study.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Chronic and acute wounds
Subjects hospitalized due to chronic and acute wounds
Device: RENASYS Film with AIRLOCK Technology
RENASYS Film with AIRLOCK Technology intended for use with Smith+Nephew RENASYS NPWT Systems
Other Names:
  • RENASYS Dressing

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Wound Healing Status
Time Frame: End of treatment period, up to 3 weeks

Progression of wound healing will be assessed by the treating clinician and compared to the wound at treatment Day 0 (baseline) by recording on a 4-point Likert scale as:

  • "Wound healed"
  • "Wound progressing to healing"
  • "Wound static"
  • "Wound deteriorating"

Any subject responding within the 2 categories of "Wound healed" or "Wound progressing to healing" will be considered a success.
End of treatment period, up to 3 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percentage Reduction in Wound Volume from Baseline to Week 3
Time Frame: Day 0, 1, 2, and 3 Weeks
Percentage reduction in wound volume as measured by imaging - day 0, weekly from week 1 to week 3 of treatment or to point of wound closure if that occurs first.
Day 0, 1, 2, and 3 Weeks
Percentage Reduction in Wound Area from Baseline to Week 3
Time Frame: Day 0, 1, 2, and 3 Weeks
Percentage reduction in wound area as measured by imaging - day 0, weekly from week 1 to week 3 of treatment or to point of wound closure if that occurs first.
Day 0, 1, 2, and 3 Weeks
Percentage Reduction in Wound depth from Baseline to Week 3
Time Frame: Day 0, 1, 2, and 3 Weeks
Percentage reduction in wound depth as measured by imaging - day 0, weekly from week 1 to week 3 of treatment or to point of wound closure if that occurs first.
Day 0, 1, 2, and 3 Weeks
Percentage Area of Wound Bed Covered with Granulation Tissue
Time Frame: Day 0, 1, 2, and 3 Weeks
The percentage of the wound bed covered with granulation tissue will be summarised using continuous summary statistics at day 0, weeks 1, 2 and 3 for each wound type and overall.
Day 0, 1, 2, and 3 Weeks
Peri-wound Pain Scores at Dressing Removal
Time Frame: Day 0, 1, 2, and 3 Weeks
Pain scores on removal of the dressing specifically from the peri-wound skin will be assessed using a 0-100 Visual Analog Scale (VAS) scale, with zero (0) indicating no pain and 100 indicating the worst possible pain.
Day 0, 1, 2, and 3 Weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Smith & Nephew, Inc.

Investigators

  • Study Chair: Sue Kemp, Smith & Nephew, Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

May 10, 2024

Primary Completion (Estimated)

April 30, 2025

Study Completion (Estimated)

April 30, 2025

Study Registration Dates

First Submitted

February 29, 2024

First Submitted That Met QC Criteria

March 11, 2024

First Posted (Actual)

March 12, 2024

Study Record Updates

Last Update Posted (Actual)

March 12, 2024

Last Update Submitted That Met QC Criteria

March 11, 2024

Last Verified

February 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • LEO.2021.10

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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