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

Not Applicable

Withdrawn

• Conditions: Abdomenal Wound Trauma
• Interventions: Device: RENASYS® TOUCH Negative Pressure Wound Therapy (NPWT) Device

• Registration Number: NCT03431220
• Lead Sponsor: Smith & Nephew, Inc.

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2016-11-17
• Study Start: 2016-12
• Primary Completion: 2017-11
• Study Completion: 2017-12
• Status Verified: 2018-02
• Study First Submitted QC: 2018-02-06
• Last Update Submitted: 2018-02-06
• Study First Posted: 2018-02-13
• Last Update Posted: 2018-02-13

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
RENASYS TOUCH NPWT System	RENASYS® TOUCH Negative Pressure Wound Therapy (NPWT) Device	Negative Pressure Wound Therapy (NPWT)

Primary Outcome Measures

Name	Time	Method
To determine the number of days taken to achieve delayed primary fascial closure.	14 days	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.

Secondary Outcome Measures

Name	Time	Method
To monitor the number and type of re-operations throughout the course of the study	14 days
To assess the ability of the NPWT system to prevent further deterioration of the open abdomen as classified by Bjorck et al., (2009)	14 days
To confirm the performance of the NPWT system in terms of: management of peritoneal fluid	14 days
To confirm the performance of the NPWT system in terms of prevention of infection	14 days
To record clinicians' overall opinion on the usability of the new device throughout the study	14 days
To confirm the performance of the NPWT system in terms of maintenance of abdominal tissue domain	14 days
To assess the number of days to achieve final closure of the open abdomen	14 days
To confirm the performance of the NPWT system in terms of reduction in edema	14 days
To confirm the performance of the NPWT system in terms of prevention of fixity	14 days
To determine the type (method) of final closure of the open abdomen	14 days
To monitor the length of stay (days) in ICU and length of stay in hospital	14 days
To assess the number of dressing changes	14 days