NCT03431220

Non-Comparative Study of Open Abdomen That Require the Use of Negative Pressure Wound Therapy (NPWT) for Temporary Abdominal Closure

A Prospective, Non-Comparative, Open, Multi-Center Study to Assess the Use of a New Negative Pressure Wound Therapy (NPWT) System (RENASYS Touch and RENASYS AB) in Temporary Abdominal Closure (TAC) For the Management of the Open Abdomen

• Status: Withdrawn
• Phase: N/A
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Smith & Nephew, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

A study in which subjects with a Grade 1 or Grade 2 open abdomen that require the use of NPWT for temporary abdominal closure. Subjects will use the NPWT system for up to 14 days, with a 21 day post study initiation follow-up assessment for latent complications and mortality.

Conditions

• Abdomenal Wound Trauma

Interventions

Type	Name	Description
DEVICE	RENASYS® TOUCH Negative Pressure Wound Therapy (NPWT) Device	NPWT applied to Grade 1 or Grade 2 open abdomen wounds for temporary abdominal closure for up to 14 days, with a 21 day post study initiation follow-up assessment.

Timeline

• Start date: 2016-12-01
• Primary completion: 2017-11-01
• Completion: 2017-12-01
• First posted: 2018-02-13
• Last updated: 2018-02-13

Locations

1 site across 1 country: United States