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

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Abdomenal Wound Trauma

Intervention / Treatment
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* Device: RENASYS® TOUCH Negative Pressure Wound Therapy (NPWT) Device


Participation Criteria
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Eligibility Criteria
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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 Patients who have participated in this trial previously and who were withdrawn.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: RENASYS TOUCH NPWT System<br>Negative Pressure Wound Therapy (NPWT) | Device: RENASYS® TOUCH Negative Pressure Wound Therapy (NPWT) Device<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 14 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To confirm the performance of the NPWT system in terms of maintenance of abdominal tissue domain |  | 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 reduction in edema |  | 14 days | 
| To confirm the performance of the NPWT system in terms of prevention of fixity |  | 14 days | 
| To confirm the performance of the NPWT system in terms of prevention of infection |  | 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 determine the type (method) of final closure of the open abdomen |  | 14 days | 
| To assess the number of days to achieve 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 monitor the number and type of re-operations throughout the course of the study |  | 14 days | 
| To assess the number of dressing changes |  | 14 days | 
| To record clinicians' overall opinion on the usability of the new device throughout the study |  | 14 days |