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

NCT01968811 | Completed Results

• 1 other identifier: Avance A01
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

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.

Conditions

Open Abdomen

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• - Fascial/Skin Closure of the Open Abdomen

  End of treatment, up to 4 days.

Study Arms (1)

Avance foam, abdominal dressing kit

EXPERIMENTAL

Device: Avance Foam dressing kit

Interventions

Avance Foam dressing kit DEVICE

Avance foam, abdominal dressing kit

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Molnlycke Health Care AB: lead

Study Sites (1)

Sahlgrenska University hospital

Gothenburg, 41345, Sweden

Location

Results Point of Contact

• Title: Dr Marcus Langenskiöld
• Organization: Sahlgrenska university Hospital

marcus.langenskiold@vgregion.se

+46 709 433160

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 14, 2013
• First Posted: October 24, 2013
• Study Start: November 1, 2013
• Primary Completion: March 1, 2014
• Last Updated: May 11, 2016
• Results First Posted: May 11, 2016

Record last verified: 2014-05

Locations

SE (1)