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

NCT02565043 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 80

Last updated 2018-02-19

No results posted yet for this study

Summary

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.

Conditions

  • Wound and Injuries
  • Surgical Wound Dehiscence

Interventions

DEVICE

RENASYS TOUCH Negative Pressure Wound Therapy System

RENASYS TOUCH NPWT System was administered to all participants.

Sponsors & Collaborators

  • Smith & Nephew, Inc.

    lead INDUSTRY

Principal Investigators

  • Martin Forlee, MD · Dr Matley & Partners

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-04-30
Primary Completion
2016-08-31
Completion
2016-11-30

Countries

  • South Africa

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02565043 on ClinicalTrials.gov