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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| RENASYS TOUCH NPWT System | Experimental | Negative Pressure Wound Therapy (NPWT) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| RENASYS® TOUCH Negative Pressure Wound Therapy (NPWT) Device | 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. |
| 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 |
| 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 |
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INCLUSION CRITERIA
EXCLUSION CRITERIA
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| Name | Affiliation | Role |
|---|---|---|
| Jaime E Dickerson, PhD | Smith & Nephew, Inc. | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Chicago | Illinois | 60612 | United States |
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| 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 |
| ID | Term |
|---|---|
| D054843 | Negative-Pressure Wound Therapy |
| ID | Term |
|---|---|
| D004322 | Drainage |
| D013812 | Therapeutics |
| D013514 | Surgical Procedures, Operative |
| D058106 | Wound Closure Techniques |
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