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

Primary Purpose

Abdomenal Wound Trauma

Status
Withdrawn
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
RENASYS® TOUCH Negative Pressure Wound Therapy (NPWT) Device
Sponsored by
Smith & Nephew, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Abdomenal Wound Trauma

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

INCLUSION CRITERIA

  1. Eligible subjects must be properly consented before enrollment. If the subject is incapable of providing consent, emergency consent procedures will be followed, or the subject's legal representative must be asked to provide consent on the subject's behalf, per the IRB guidelines.
  2. Subjects must be at least eighteen (18) yeaTS of age, or older.
  3. Males and non-pregnant females.
  4. Grade 1 or Grade 2 open abdomen patients who would benefit from temporary abdominal closure (TAC) with topical Negative Pressure Wound Therapy (NPWT).

EXCLUSION CRITERIA

  1. Grade 3 and Grade 4 open abdomens.
  2. Malignancy in the reference wound bed or margins of the wound.
  3. Patients with non-enteric unexplored fistulas.
  4. High risk for imminent death, as determined by the attending surgeon and Principal Investigator (PI).
  5. Pre-existing large ventral hernia.
  6. Significant loss of abdominal wall fascia as a result of trauma or infection.
  7. Patients with a known hist01y of poor compliance with medical treatment.
  8. Patients who have participated in this trial previously and who were withdrawn.

Sites / Locations

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

RENASYS TOUCH NPWT System

Arm Description

Negative Pressure Wound Therapy (NPWT)

Outcomes

Primary Outcome Measures

To determine the number of days taken to achieve delayed primary fascial closure.
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

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

Full Information

First Posted
November 17, 2016
Last Updated
February 6, 2018
Sponsor
Smith & Nephew, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT03431220
Brief Title
Non-Comparative Study of Open Abdomen That Require the Use of Negative Pressure Wound Therapy (NPWT) for Temporary Abdominal Closure
Official Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
February 2018
Overall Recruitment Status
Withdrawn
Study Start Date
December 2016 (Anticipated)
Primary Completion Date
November 2017 (Anticipated)
Study Completion Date
December 2017 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Smith & Nephew, Inc.

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Abdomenal Wound Trauma

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
0 (Actual)

8. Arms, Groups, and Interventions

Arm Title
RENASYS TOUCH NPWT System
Arm Type
Experimental
Arm Description
Negative Pressure Wound Therapy (NPWT)
Intervention Type
Device
Intervention Name(s)
RENASYS® TOUCH Negative Pressure Wound Therapy (NPWT) Device
Intervention Description
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.
Primary Outcome Measure Information:
Title
To determine the number of days taken to achieve delayed primary fascial closure.
Description
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.
Time Frame
14 days
Secondary Outcome Measure Information:
Title
To confirm the performance of the NPWT system in terms of maintenance of abdominal tissue domain
Time Frame
14 days
Title
To confirm the performance of the NPWT system in terms of: management of peritoneal fluid
Time Frame
14 days
Title
To confirm the performance of the NPWT system in terms of reduction in edema
Time Frame
14 days
Title
To confirm the performance of the NPWT system in terms of prevention of fixity
Time Frame
14 days
Title
To confirm the performance of the NPWT system in terms of prevention of infection
Time Frame
14 days
Title
To assess the ability of the NPWT system to prevent further deterioration of the open abdomen as classified by Bjorck et al., (2009)
Time Frame
14 days
Title
To determine the type (method) of final closure of the open abdomen
Time Frame
14 days
Title
To assess the number of days to achieve final closure of the open abdomen
Time Frame
14 days
Title
To monitor the length of stay (days) in ICU and length of stay in hospital
Time Frame
14 days
Title
To monitor the number and type of re-operations throughout the course of the study
Time Frame
14 days
Title
To assess the number of dressing changes
Time Frame
14 days
Title
To record clinicians' overall opinion on the usability of the new device throughout the study
Time Frame
14 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
INCLUSION CRITERIA Eligible subjects must be properly consented before enrollment. If the subject is incapable of providing consent, emergency consent procedures will be followed, or the subject's legal representative must be asked to provide consent on the subject's behalf, per the IRB guidelines. Subjects must be at least eighteen (18) yeaTS of age, or older. Males and non-pregnant females. Grade 1 or Grade 2 open abdomen patients who would benefit from temporary abdominal closure (TAC) with topical Negative Pressure Wound Therapy (NPWT). EXCLUSION CRITERIA Grade 3 and Grade 4 open abdomens. Malignancy in the reference wound bed or margins of the wound. Patients with non-enteric unexplored fistulas. High risk for imminent death, as determined by the attending surgeon and Principal Investigator (PI). Pre-existing large ventral hernia. Significant loss of abdominal wall fascia as a result of trauma or infection. Patients with a known hist01y of poor compliance with medical treatment. Patients who have participated in this trial previously and who were withdrawn.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jaime E Dickerson, PhD
Organizational Affiliation
Smith & Nephew, Inc.
Official's Role
Study Chair
Facility Information:
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60612
Country
United States

12. IPD Sharing Statement

Learn more about this trial

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

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