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

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Open Abdomen

Intervention / Treatment
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* Device: Avance Foam dressing kit


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Provision of written informed consent from subject or family member Subjects with open abdomen suitable for temporary closure with NPWT therapy Subjects where the viscera and/or abdominal organs need to be protected by an abdominal organ contact layer (OCL) Subject which (at the time of the baseline visit) are planned to be cared for between dressing changes at Intensive Care Unit Male or female, 18 years and above Exclusion Criteria: Synthetic mesh inserted in the abdomen Non-enteric fistulae or unexplored fistulas Untreated osteomyelitis Malignant wounds Abdominal wall hernia Subjects previously treated with an NPWT abdominal dressing Known allergy or hypersensitivity to any of the components in the dressing Pregnancy Subjects not suitable for the investigation according to the investigator's judgement Subjects included in other ongoing clinical investigation at present which could interfere with this investigation, as judged by the investigator

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Avance foam, abdominal dressing kit<br> | Device: Avance Foam dressing kit<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To Evaluate the Performance of the Dressing Kit as Part of a Negative Pressure System in Post Market Clinical Follow-up Settings | Outcome of each subject was evaluated and presented individually. Questionnaires answered by surgeon at application and removal of the kit; Baseline Overall ease of application of the kit: No. of surgeons rated as; Very easy= 4/Easy=3/Somewhat easy=2/Not easy Overall satisfaction with the kit:No. of surgeons rated as Very satisfied=3/ Satisfied=5/ Unsatisfied=2/ Very unsatisfied=0 Questionnaires were answered by surgeon at application and removal of the kit; Visit 2 Overall ease of application of the kit:No.of surgeons rated as Very easy= 2/Easy=5/Somewhat easy=0/Not easy=1 Overall satisfaction with the kit: No.of surgeons rated as Very satisfied=1/ Satisfied=3/ Unsatisfied=4/ Very unsatisfied=0 Visit 3 Overall ease of application of the kit: No.of surgeons rated as Very easy= 0/Easy=6/Somewhat easy=0/Not easy=0 Overall satisfaction. No of surgeons rated as Very satisfied=0, satisfied=4, unsatisfied=2, very unsatisfied=0 | From 1 to 3 visit, depending on each subject/wound, up to 4 days. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| - Fascial/Skin Closure of the Open Abdomen | The performance objective is assessed through general application and removal questions after each investigational device handling. | End of treatment, up to 4 days. |