NCT02565043

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

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 80 (actual)
• Sponsor: Smith & Nephew, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

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.

Conditions

• Wound and Injuries
• Surgical Wound Dehiscence

Interventions

Type	Name	Description
DEVICE	RENASYS TOUCH Negative Pressure Wound Therapy System	RENASYS TOUCH NPWT System was administered to all participants.

Timeline

• Start date: 2015-04-01
• Primary completion: 2016-08-01
• Completion: 2016-11-01
• First posted: 2015-10-01
• Last updated: 2018-02-19

Locations

2 sites across 1 country: South Africa