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OpenTrials
Completed

NCT Number: NCT01968811

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

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.

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Key information

Conditions

Open Abdomen

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Sahlgrenska University hospital

Gothenburg, 41345, Sweden

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Avance Foam dressing kit

Device

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

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

    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

Secondary outcomes

  1. - Fascial/Skin Closure of the Open Abdomen

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

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

Sponsors and collaborators

Lead sponsor

Molnlycke Health Care AB

Industry

Registry information

Official study title

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

Important dates

Study start
2013
Primary completion
2014
First posted
Oct 24, 2013
Registry last updated
May 11, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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