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

Not Applicable

Completed

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.

Recruitment & Eligibility

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

Arm && Interventions

Group	Intervention	Description
Avance foam, abdominal dressing kit	Avance Foam dressing kit	-

Primary Outcome Measures

Name	Time	Method
To Evaluate the Performance of the Dressing Kit as Part of a Negative Pressure System in Post Market Clinical Follow-up Settings	From 1 to 3 visit, depending on each subject/wound, up to 4 days.	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

Secondary Outcome Measures

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