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

Molnlycke Health Care

Status: Completed

Conditions: Open Abdomen

Treatments: Device: Avance Foam dressing kit

Study type: Interventional

Funder types: Industry

Identifiers

NCT01968811

Avance A01

Details and patient eligibility

About

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.

Enrollment: 10 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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10 participants in 1 patient group

Avance foam, abdominal dressing kit

Experimental group

Treatment:

Device: Avance Foam dressing kit