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

Open Abdomen Clinical Trial

Official title:

A Multi-Centre, Post CE Mark, Open Clinical Investigation to Evaluate an Abdominal NPWT (Negative Pressure Wound Therapy) System (Avance® Pump and Avance® Foam Abdominal Dressing Kit) in Subjects With Open Abdominal Wounds

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01968811
• Other study ID #: Avance A01
• Status: Completed
• Phase: N/A
• First received: October 14, 2013
• Last updated: May 6, 2014
• Start date: November 2013

Study information

• Verified date: May 2014
• Source: Molnlycke Health Care AB
• Contact: n/a
• Is FDA regulated: No
• Health authority: Sweden: Regional Ethical Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 10
• Est. primary completion date: March 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Open Abdomen

Intervention

Device:
• Avance Foam dressing kit

Locations

Country	Name	City	State
Sweden	Sahlgrenska University hospital	Göteborg

Sponsors (1)

Lead Sponsor	Collaborator
Molnlycke Health Care AB

Country where clinical trial is conducted

Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of participants with Adverse events as a Measure of Safety and tolerability.		participants will be followed until abdominal closure or until insertion of synthetic mesh, an expected avarage of 10 days	No
Secondary	- Fascial/Skin closure of the open abdomen		At end of treatment, an expected average is 10 days.	No