N/A
Completed N=10
Post Market Clinical Follow Up Study of Avance Foam Abdominal Dressing Kit in Open Abdomen
Open Abdomen
Source: ClinicalTrials.gov NCT01968811 ↗
Enrolled (actual)
10
Serious AEs
50.0%
Results posted
May 2016
Primary outcomePrimary: To Evaluate the Performance of the Dressing Kit as Part of a Negative Pressure System in Post Market Clinical Follow-up Settings — 4; 3; 2; 1 number of surgeons
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY To Evaluate the Performance of the Dressing Kit as Part of a Negative Pressure System in Post Market Clinical Follow-up Settings |
4; 3; 2; 1; 3; 5 | — |
| SECONDARY - Fascial/Skin Closure of the Open Abdomen |
5; 3 | — |
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT01968811). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.