N/A N=10 Treatment

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

Open Abdomen

Bottom Line

View on ClinicalTrials.gov: NCT01968811 ↗

Enrolled (actual)

Serious AEs

50.0%

Results posted

May 2016

Primary outcome: 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 number of surgeons

Study Design & Population

Study type: Interventional
Phase: N/A
Interventions: Avance Foam dressing kit (Device)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: Molnlycke Health Care AB
Primary completion: Mar 2014

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	—

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.

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

View full record on ClinicalTrials.gov →

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.