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

N/ACompletedNCT01968811

Molnlycke Health Care AB10 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Open Abdomen

Interventions

Avance Foam dressing kitDEVICE

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

Sahlgrenska University hospital

Gothenburg, Sweden

Outcomes

Primary Outcomes

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

Time frame: From 1 to 3 visit, depending on each subject/wound, up to 4 days.

Secondary Outcomes

- Fascial/Skin Closure of the Open Abdomen

The performance objective is assessed through general application and removal questions after each investigational device handling.

Time frame: End of treatment, up to 4 days.

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.