Vacuum Assisted Wound Closure and Permanent On-lay Mesh-mediated Fascial Traction in Patients With Open Abdomen

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorSkane University Hospital

About this trial

Open abdomen therapy is used in trauma and non-trauma patients where the abdomen is not possible to close, or the intraabdominal conditions is not suitable for closure. In 2007, a new technique that made use of negative pressure wound therapy and mesh-mediated fascial traction for closure of the open abdomen was described from the Department of Surgery in Malmö, Sweden. With this new technique, fascial closure rates were high but long-term incisional hernia formation was seen in approximately half of the patients alive after five years. To overcome the high incisional hernia incidence, a new technique utilizing a permanent on-lay mesh for traction and reinforcement of the incision at fascial closure was developed.

Hypothesis Lower incisional hernia rates in comparison with literature reported results of other techniques for open abdomen treatment, with similar complication rates.

Aims To evaluate early and late clinical outcome of the novel vacuum-assisted wound closure and permanent on-lay mesh-mediated fascial traction technique.

Design A prospective six-center cohort study in Sweden and Denmark. Study inclusion during a two-year period or longer to include at least 100 patients. Statistical analysis will be done by intention-to-treat and as sub-group per-protocol analysis.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

None

Disqualifiers

Patient declining participation

Existing incisional hernia or primary ventral hernia ≥3 cm

Existing mesh in the abdominal wall, located in the midline and irrespective of mesh size

Existing ostomy/parastomal hernia located in a position that prevents the VAWCPOM technique to be utilized

Trial design

Design model

Single group

Treatments tested in this trial

  • Vacuum Assisted Wound Closure and Permanent On-lay Mesh-mediated fascial traction (VAWCPOM)

    Procedure/Surgery

    Vacuum Assisted Wound Closure and Permanent On-lay Mesh-mediated fascial traction (VAWCPOM) in patients with open abdomen.

Treatment groups

100 Participants
are divided into 1 treatment group
Group A: Vacuum Assisted Wound Closure and Permanent On-lay Mesh-mediated fascial tractionOther 1 intervention

Trial outcomes

Primary outcomes

1

Incisional hernia at 1 year

Incidence of incisional hernia after open abdomen closure with the technique

Time frame
1 year, year 1

Secondary outcomes

1

Fascial closure rate

Percentage of patients possible to closed with the technique

Time frame
During hospital stay
2

Complications

Complications related to the technique

Time frame
Up to 12 weeks
3

Incisional hernia

Incisional hernia incidence after three years

Time frame
Through study completion, 3 years
4

EQ5D

Patient reported outcome of generic quality of life

Time frame
Through study completion, 3 years

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

This trial is not recruiting at the moment. You can still explore other options: