Vacuum Assisted Wound Closure (VAWC) and Mesh Mediated Fascial Traction

Vacuum Assisted Wound Closure (VAWC) and Mesh Mediated Fascial Traction - Prospective Study of a Novel Technique for Open Abdomen Closure

The purpose of this multicenter trial is to prospectively evaluate a novel combination of vacuum assisted wound closure (VAWC) and mesh mediated fascial traction for closure of open abdomens.

Study Overview

• Status: Completed
• Conditions: Fascial Closure; Open Abdomen
• Intervention / Treatment: Procedure: VAWC and mesh mediated fascial traction

Detailed Description

Open abdomen treatment often results in difficulties in closing the abdomen. Highest closure rates are seen with the vacuum assisted wound closure (VAWC) technique. Failures with this technique is occasionally experienced, especially in cases with severe visceral swelling needing longer treatment periods with open abdomen. A novel combination of vacuum assisted wound closure and mesh mediated fascial traction for managing the open abdomen was therefore developed and initially tested in a small pilot-like study with encouraging results with late primary closure of the abdomens in all seven patients.

In this multicenter study we prospectively evaluate the technique.

Inclusion criteria:

All patients treated with open abdomen at the 4 participating hospitals are registered, and only those patients who have commenced therapy with VAWC and mesh mediated fascial traction will be included in the study in an intention to treat model.

Exclusion criteria:

Treatment of open abdomen with other techniques.

Method:

• The first period of 2-5 days only the abdominal VAWC dressing is applied.
• On day 3-10 a polypropylene mesh is sutured to the fascial edges, between the two layers of the VAWC system, and tightened.
• The VAWC dressing is changed and the mesh tightened every 2-3 days, resulting in gradual approximation of the fascial edges.
• Finally the mesh is removed and the fascia is closed.
• At closure the wound to suture length is registered.

Primary endpoint:

Frequency of primary fascial closure.

Secondary endpoints:

• study of factors associated with failure of fascial closure and in-hospital mortality,
• abdominal pressure variation attributable to the use of the technique,
• duration of treatment with open abdomen,
• frequency of incisional hernia after one and five years.

Duration of the study:

3-5 years. Enrollment of open abdomen cases.

Follow-up schedule for patients:

• Clinical evaluation at 1 and 5 years.
• CT-examination at 1 year.

• Study Type: Interventional
• Enrollment (Actual): 111
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Sweden
  • Falun, Sweden, 791 82
    • Department of Surgery, Falu Hospital
  • Gävle, Sweden, 801 87
    • Department of Surgery, Gävle Hospital
  • Malmö, Sweden, 205 02
    • Department of Surgery, Malmö University Hospital
  • Malmö, Sweden, 205 02
    • Department of Vascular Surgery, Malmö University Hospital
  • Uppsala, Sweden, 751 85
    • Department of Surgery, Uppsala University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• open abdomen patients with midline incisions, where vacuum assisted wound closure system and mesh mediated fascial traction is applicable

Exclusion Criteria:

• open abdomen patients treated otherwise

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Other: VAWC and mesh mediated fascial traction; This is a study aiming to evaluate one technique for temporary abdominal closure for open abdomen therapy in all patients applicable according to the inclusion criteria

Procedure: VAWC and mesh mediated fascial traction; The first period of 2-5 days only the abdominal VAWC dressing is applied. On day 3-10 a polypropylene mesh is sutured to the fascial edges, between the two layers of the VAWC system, and tightened. The VAWC dressing is changed and the mesh tightened every 2-3 days, resulting in gradual approximation of the fascial edges. Finally the mesh is removed and the fascia is closed

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Primary fascial closure rate	Primary fascial closure rate with the technique	2 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Factors associated with failure of fascial closure and in-hospital mortality, abdominal pressure, duration of treatment with open abdomen, frequency of incisional hernia development	Early, intermediate and late outcomes	5 years

Collaborators and Investigators

• Sponsor: Skane University Hospital
• Collaborators: The Swedish Research Council; Uppsala University Hospital; Falu Hospital; Gävle Hospital; KCI Europe Holding B.V.
• Investigators: Principal Investigator: Ulf Petersson, MD, PhD, Department of Surgery, Malmö University Hospital, Sweden

Publications and helpful links

General Publications

• Bjarnason T, Montgomery A, Ekberg O, Acosta S, Svensson M, Wanhainen A, Bjorck M, Petersson U. One-year follow-up after open abdomen therapy with vacuum-assisted wound closure and mesh-mediated fascial traction. World J Surg. 2013 Sep;37(9):2031-8. doi: 10.1007/s00268-013-2082-x.
• Sorelius K, Wanhainen A, Acosta S, Svensson M, Djavani-Gidlund K, Bjorck M. Open abdomen treatment after aortic aneurysm repair with vacuum-assisted wound closure and mesh-mediated fascial traction. Eur J Vasc Endovasc Surg. 2013 Jun;45(6):588-94. doi: 10.1016/j.ejvs.2013.01.041. Epub 2013 Mar 1.

Study record dates

Study Major Dates

• Study Start (Actual): April 1, 2006
• Primary Completion (Actual): August 31, 2009
• Study Completion (Actual): April 1, 2015

Study Registration Dates

• First Submitted: June 29, 2007
• First Submitted That Met QC Criteria: June 29, 2007
• First Posted (Estimate): July 2, 2007

Study Record Updates

• Last Update Posted (Actual): December 29, 2017
• Last Update Submitted That Met QC Criteria: December 28, 2017
• Last Verified: December 1, 2017

More Information

Terms related to this study

• Keywords: Mesh; Abdominal compartment syndrome; Fascial closure; Incisional hernia; Open abdomen; Vacuum assisted wound closure; Intraabdominal pressure
• Other Study ID Numbers: EPNLund 564/2005