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

Last updated: October 18, 2024
Sponsor: Smith & Nephew, Inc.
Overall Status: Active - Recruiting

Phase

N/A

Condition

Pressure Ulcers

Treatment

RENASYS Film with AIRLOCK Technology

Clinical Study ID

NCT06306716
LEO.2021.10
  • Ages > 18
  • All Genders

Study Summary

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.

Eligibility Criteria

Inclusion

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-upvisits in clinic following discharge.

  • Subject has a wound that, per Instructions for Use (IFU), is indicated and suitablefor management with NPWT and fits one of the following wound types: a. Chronic* (this may include Diabetic Foot Ulcers (DFUs), Venous Leg Ulcers (VLUs), PressureUlcers but this is not an exhaustive list) b. Acute (this may include traumatic anddehisced surgical wounds and partial thickness burns) *Chronic wound in this studyis defined as any wound of less than three months duration that is not healing afterthirty (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 theavailable sizes of the study device

Exclusion

Exclusion Criteria:

  • Subject has hypersensitivity to the use of the RENASYS NPWT System or itscomponents, or a contraindication per the IFU such as: a. exposed arteries, veins,organs, or nerves b. necrotic tissue with eschar present (unless adequatelydebrided) 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 withinthirty (30) days of baseline visit or during the study.

  • Subject has skin features (e.g., tattoos, pre-existing scarring, etc.) which in theopinion of the investigator will interfere with the study assessments.

  • For lower extremity wounds**, any subject with a wound on a limb with an inadequatearterial supply confirmed by one of the following within 14 days of treatment:

  1. Ankle Brachial Index (ABI) <0.7

  2. Toe Brachial Index (TBI) <0.5

  3. Great toe pressure <40mmHg

  4. Abnormal triphasic or biphasic waveform patterns at the ankle **This criteriais not applicable for patients having an above, or below knee amputation.

  • 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 thatare relevant to the decision to participate, or who could be manipulated or undulyinfluenced as a result of a compromised position, expectation of benefits or fear ofretaliatory response). Ethnic minorities will be included providing they meet otherinclusion 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 Investigatorwould preclude safe subject participation in the study.

Study Design

Total Participants: 23
Treatment Group(s): 1
Primary Treatment: RENASYS Film with AIRLOCK Technology
Phase:
Study Start date:
May 30, 2024
Estimated Completion Date:
September 30, 2025

Study 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.

Connect with a study center

  • Lawson Health Research Institute

    London, Ontario N6C 2R5
    Canada

    Active - Recruiting

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