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

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

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 Overview

• Status: Completed
• Conditions: Open Abdomen
• Intervention / Treatment: Device: Avance Foam dressing kit

• Study Type: Interventional
• Enrollment (Actual): 10
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Sweden
  • Göteborg, Sweden, 41345
    • Sahlgrenska University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Avance foam, abdominal dressing kit	Device: Avance Foam dressing kit

What is the study measuring?

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.

Collaborators and Investigators

• Sponsor: Molnlycke Health Care AB

Study record dates

Study Major Dates

• Study Start: November 1, 2013
• Primary Completion (ACTUAL): March 1, 2014

Study Registration Dates

• First Submitted: October 14, 2013
• First Submitted That Met QC Criteria: October 18, 2013
• First Posted (ESTIMATE): October 24, 2013

Study Record Updates

• Last Update Posted (ESTIMATE): May 11, 2016
• Last Update Submitted That Met QC Criteria: April 6, 2016
• Last Verified: May 1, 2014

More Information

Terms related to this study

• Other Study ID Numbers: Avance A01