Post Market Clinical Follow Up Study of Avance Foam Abdominal Dressing Kit in Open Abdomen

NCT ID: NCT01968811

Last Updated: 2016-05-11

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 10 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-11-30

Brief Summary

The investigation is a Post Marketing Follow-Up Study for the Avance Foam Abdominal Dressing Kit conducted as part of Mölnlycke Health Care's quality system. The primary objective is to evaluate the dressing kit as part of a negative pressure system. The secondary objectives are to collect and evaluate safety data, performance data and information on technical complications.

Conditions

Open Abdomen

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Avance foam, abdominal dressing kit

Group Type: EXPERIMENTAL

Avance Foam dressing kit

Intervention Type: DEVICE

Interventions

Avance Foam dressing kit

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

1. Provision of written informed consent from subject or family member

2. Subjects with open abdomen suitable for temporary closure with NPWT therapy

3. Subjects where the viscera and/or abdominal organs need to be protected by an abdominal organ contact layer (OCL)

4. Subject which (at the time of the baseline visit) are planned to be cared for between dressing changes at Intensive Care Unit

5. Male or female, 18 years and above

Exclusion Criteria

1. Synthetic mesh inserted in the abdomen

2. Non-enteric fistulae or unexplored fistulas

3. Untreated osteomyelitis

4. Malignant wounds

5. Abdominal wall hernia

6. Subjects previously treated with an NPWT abdominal dressing

7. Known allergy or hypersensitivity to any of the components in the dressing

8. Pregnancy

9. Subjects not suitable for the investigation according to the investigator's judgement

10. Subjects included in other ongoing clinical investigation at present which could interfere with this investigation, as judged by the investigator

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Molnlycke Health Care AB

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Sahlgrenska University hospital

Gothenburg, , Sweden

Countries

Sweden

Other Identifiers

Avance A01

Identifier Type: -

Identifier Source: org_study_id