The Clinical Efficacy of RENASYS TOUCH NPWT System in the Management of Acute, Sub-acute and Chronic Wounds (NPWT)

February 14, 2018 updated by: Smith & Nephew, Inc.

A Prospective, Open, Multi-centre Study to Evaluate Clinical Efficacy, Functionality and Device Performance of a New Portable Negative Pressure Wound Therapy System (RENASYS TOUCH) in the Management of Acute, Sub-acute and Chronic Wounds

The study is looking at the clinical efficacy, functionality and device performance of a new Negative Pressure Wound Therapy (NPWT) system in the management of a variety of wound types, in a real-life clinical setting. The study will comprise a prospective, open-labeled, multi-center study in a number of care-settings (both hospital and community) in South Africa. The patient's reference wound will be randomized to treatment with either intermittent or continuous NPWT mode to assess whether the delivery of NPWT via each of these therapy settings will have an effect on the rate and quality of wound healing.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

The study will comprise a prospective, open-labeled, multi-center study to assess the clinical efficacy, functionality and device performance of the new portable negative pressure wound therapy system in the management of acute, sub-acute and chronic wounds.

The patient's reference wound will be randomized to treatment with either intermittent or continuous NPWT mode to ensure minimum numbers in each group for analysis.

The primary objective of the study is to determine the time (days) to achieve the point where the reference wound is ready to be closed either by surgical intervention (STSG, simple flap or suturing) or by secondary intention.

Study Type

Interventional

Enrollment (Actual)

80

Phase

  • Not Applicable

Contacts and Locations

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

Study Locations

  • South Africa
    • Cape Town
      • Bellville, Cape Town, South Africa, 7530
        • Tiervlei Trail Centre
      • Claremont, Cape Town, South Africa, 7708
        • Dr Matley & Partners

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

16 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • The patient is able to understand the study and is willing to consent to the study
  • The patient consents to the on-going use of their de-identified photos by the Sponsor for purposes outside of this study
  • Patients must be at least 18 years old
  • Males and females. If female, they must not be pregnant. If female and of reproductive age, a pregnancy test will be provided
  • Patient must have an acute, sub-acute or chronic wound that would benefit from the application of topical Negative Pressure Wound Therapy (NPWT)
  • Patients must have an acute or sub-acute wound requiring wound bed preparation for an expected minimum of 4 days in advance of either planned surgical closure (including delayed primary closure, flaps or grafts) or planned secondary closure, OR a chronic wound requiring wound bed preparation in advance of planned surgical closure (not secondary intention)
  • The patient, or the patient's legal representative, if the patient is incapable of giving legal consent, is able to understand the trial and is willing to consent to the trial

Exclusion Criteria:

  • Patients with a known history of poor compliance with medical treatment.
  • Patients who have participated in this study previously and who [healed or] were withdrawn.
  • Patients who are unable to understand the aims and objectives of the study.
  • Presence of necrotic tissue, or >25% slough in the reference wound bed. Once debridement has taken place, treatment with the investigational product may proceed
  • Patients whose reference wound displays evidence of extensive tunnelling or sinus tracts
  • Previously confirmed and untreated osteomyelitis
  • Malignancy in the reference wound
  • Non-enteric and unexplored Fistulas
  • Presence of untreated infection in the reference wound bed (Infection must be treated with systemic antibiotics to permit inclusion in the trial and can be administered concurrently during the trial treatment regime)
  • Active bleeding. Once haemostasis has been achieved, treatment with the investigational product may proceed
  • Exposure of blood vessels or organs at the base of the reference wound
  • Patients with a known history of poor compliance with medical treatment
  • Patients who have participated in this trial previously and who healed or were withdrawn
  • Patients treated on an out-patient basis who cannot continue to be treated as out-patients and/or attend the clinic for dressing changes as detailed in the treatment regimen of the study protocol
  • Patients whose wounds are not suitable for treatment with intermittent therapy mode (e.g. highly exuding wounds, wounds with tunnels or undermining, wounds in difficult areas where maintaining a seal is problematic, patients who experience severe pain during intermittent therapy)
  • Patients who are employees of Smith & Nephew group companies.

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

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: RENASYS TOUCH Negative Pressure Wound Therapy Device
Active Device: "RENASYS TOUCH NPWT" device administered to all patients using the intermittent/variable therapy mode, for up to 28 days of therapy.
Device: RENASYS TOUCH Negative Pressure Wound Therapy System
RENASYS TOUCH NPWT System was administered to all participants.
Other Names:
  • "RENASYS TOUCH NPWT" System
Active Comparator: RENASYS TOUCH Negative Pressure Wound Therapy System
Active Device: "RENASYS TOUCH NPWT" device administered to all patients using the continuous therapy mode for up to 28 days of therapy.
Device: RENASYS TOUCH Negative Pressure Wound Therapy System
RENASYS TOUCH NPWT System was administered to all participants.
Other Names:
  • "RENASYS TOUCH NPWT" System

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
The time to achieve the point where the reference wound is ready to be closed either by surgical intervention (STSG, simple flap or suturing) or by secondary intention
Time Frame: 28 days
28 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
To determine the percentage of wounds that are ready to be closed either by surgical intervention (STSG, simple flap or suturing) or by secondary intention
Time Frame: 28 days
28 days
To assess the percentage of wounds that are ready to be closed either by surgical intervention (STSG, simple flap or suturing) or by secondary intention, in wounds that are randomized to intermittent or continuous therapy mode
Time Frame: 28 days
28 days
The percentage change in wound area
Time Frame: 28 days
To assess progress towards wound closure using the percentage change in wound area (cm2)
28 days
The number of patients with a confirmed clinical infection or presenting with clinical signs of infection
Time Frame: 28 days
Patients that have a confirmed clinical infection or the number of patients that present with clinical signs of infection in their reference wound
28 days
The number of patients with the condition of their surrounding skin recorded as either Healthy, Fragile, Inflamed, Macerated, Dry and Flaky, or Other
Time Frame: 28 days
To assess the condition of the patients surrounding skin
28 days
To record the patients level of pain using a 10-point pain scale, on application and during therapy, in patient's wounds that are randomised to intermittent or continuous therapy mode
Time Frame: 28 days
To assess the patients level of pain on application and during therapy
28 days
The study will monitor safety in use and will record and assess all adverse events that occur during the study
Time Frame: 28 days
28 days
The percentage change in wound volume
Time Frame: 28 days
To assess progress towards wound closure using the percentage change in wound area (cm3)
28 days
The percentage change in wound depth
Time Frame: 28 days
To assess progress towards wound closure using the percentage change in wound depth (mm)
28 days

Collaborators and Investigators

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

Sponsor

Smith & Nephew, Inc.

Investigators

  • Principal Investigator: Martin Forlee, MD, Dr Matley & Partners

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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

April 1, 2015

Primary Completion (Actual)

August 1, 2016

Study Completion (Actual)

November 1, 2016

Study Registration Dates

First Submitted

September 28, 2015

First Submitted That Met QC Criteria

September 29, 2015

First Posted (Estimate)

October 1, 2015

Study Record Updates

Last Update Posted (Actual)

February 19, 2018

Last Update Submitted That Met QC Criteria

February 14, 2018

Last Verified

February 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CT13/01

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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