Trials Sponsors Conditions Drugs Pricing

Conditions

Abdomenal Wound Trauma

Outcome Measures

Primary Outcomes (1)

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 Outcomes (12)

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
+7 more secondary outcomes

Study Arms (1)

RENASYS TOUCH NPWT System

EXPERIMENTAL

Negative Pressure Wound Therapy (NPWT)

Device: RENASYS® TOUCH Negative Pressure Wound Therapy (NPWT) Device

Interventions

RENASYS® TOUCH Negative Pressure Wound Therapy (NPWT) DeviceDevice

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.

RENASYS TOUCH NPWT System

Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.

Eligibility Criteria

Age18 Years+

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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.

Sponsors & Collaborators

Smith & Nephew, Inc.
Industrylead

Study Sites (1)

Chicago, Illinois, 60612, United States

MeSH Terms

Interventions

Negative-Pressure Wound Therapy

Intervention Hierarchy (Ancestors)

DrainageTherapeuticsSurgical Procedures, OperativeWound Closure Techniques

Study Officials

Jaime E Dickerson, PhD
Smith & Nephew, Inc.
STUDY CHAIR

Enrollment

0 participants (actual enrollment reported by the registry).

Study Design

Study Type: interventional
Phase: not applicable
Allocation: NA
Masking: NONE
Purpose: TREATMENT
Intervention Model: SINGLE GROUP
Sponsor Type: INDUSTRY
Responsible Party: SPONSOR

Study Record Dates

First Submitted

November 17, 2016

First Posted

February 13, 2018

Study Start

December 2016

Estimated (date passed)

This estimate has passed. The registry has not confirmed an actual date for this milestone.

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

Brief Summary

Registry Overview

Trial Relationships

Study Timeline

First Submitted

Study Start

Primary Completion

Study Completion

First Posted

Conditions

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (12)

Study Arms (1)

RENASYS TOUCH NPWT System

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

MeSH Terms

Interventions

Intervention Hierarchy (Ancestors)

Study Officials

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Source record

Locations

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

First Submitted

Study Start

Primary Completion

Study Completion

First Posted

Conditions

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (12)

Study Arms (1)

RENASYS TOUCH NPWT System

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

MeSH Terms

Interventions

Intervention Hierarchy (Ancestors)

Study Officials

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Source record

Locations