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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

NA

Study Classification

INTERVENTIONAL

Study Start Date

2016-12-31

Study Completion Date

2017-12-31

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.

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Detailed Description

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Conditions

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Abdomenal Wound Trauma

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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RENASYS TOUCH NPWT System

Negative Pressure Wound Therapy (NPWT)

Group Type EXPERIMENTAL

RENASYS® TOUCH Negative Pressure Wound Therapy (NPWT) Device

Intervention Type 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.

Interventions

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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.

Intervention Type DEVICE

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No