NCT00494793

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
111

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Apr 2006

Longer than P75 for not_applicable

Geographic Reach
1 country

5 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2006

Completed
1.2 years until next milestone

First Submitted

Initial submission to the registry

June 29, 2007

Completed
3 days until next milestone

First Posted

Study publicly available on registry

July 2, 2007

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 31, 2009

Completed
5.6 years until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2015

Completed
Last Updated

December 29, 2017

Status Verified

December 1, 2017

Enrollment Period

3.4 years

First QC Date

June 29, 2007

Last Update Submit

December 28, 2017

Conditions

Open AbdomenFascial Closure

Keywords

Open abdomenFascial closureVacuum assisted wound closureMeshAbdominal compartment syndromeIntraabdominal pressureIncisional hernia

Outcome Measures

Primary Outcomes (1)

  • Primary fascial closure rate

    Primary fascial closure rate with the technique

    2 months

Secondary Outcomes (1)

  • Factors associated with failure of fascial closure and in-hospital mortality, abdominal pressure, duration of treatment with open abdomen, frequency of incisional hernia development

    5 years

Study Arms (1)

VAWC and mesh mediated fascial traction

OTHER

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

Interventions

VAWC and mesh mediated fascial tractionPROCEDURE

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

VAWC and mesh mediated fascial traction

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • open abdomen patients treated otherwise

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (5)

Department of Surgery, Falu Hospital

Falun, 791 82, Sweden

Location

Department of Surgery, Gävle Hospital

Gävle, 801 87, Sweden

Location

Department of Surgery, Malmö University Hospital

Malmo, 205 02, Sweden

Location

Department of Vascular Surgery, Malmö University Hospital

Malmo, 205 02, Sweden

Location

Department of Surgery, Uppsala University Hospital

Uppsala, 751 85, Sweden

Location

Related Publications (2)

  • 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.

    PMID: 23703638DERIVED

  • 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.

    PMID: 23465456DERIVED

MeSH Terms

Conditions

Intra-Abdominal HypertensionIncisional Hernia

Condition Hierarchy (Ancestors)

Compartment SyndromesMuscular DiseasesMusculoskeletal DiseasesVascular DiseasesCardiovascular DiseasesHerniaPathological Conditions, AnatomicalPathological Conditions, Signs and SymptomsPostoperative ComplicationsPathologic Processes

Study Officials

  • Ulf Petersson, MD, PhD

    Department of Surgery, Malmö University Hospital, Sweden

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD, PhD, Ass prof

Study Record Dates

First Submitted

June 29, 2007

First Posted

July 2, 2007

Study Start

April 1, 2006

Primary Completion

August 31, 2009

Study Completion

April 1, 2015

Last Updated

December 29, 2017

Record last verified: 2017-12

Locations

SE(5)