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

Incisional Hernia Clinical Trial

— VAWCPOM  

Official title:

Vacuum Assisted Wound Closure and Permanent On-lay Mesh-mediated Fascial Traction (VAWCPOM) in Patients With Open Abdomen - a Prospective Multi-center Cohort Study

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05568238
• Other study ID #: 131-22
• Status: Not yet recruiting
• Phase: N/A
• Start date: October 2022
• Est. completion date: December 2027

Study information

• Verified date: September 2022
• Source: Skane University Hospital
• Contact: Ulf Pettersson, Ass prof
• Phone: +46705657446
• Email: ulf.a.petersson[@]telia.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 100
• Est. completion date: December 2027
• Est. primary completion date: December 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• All patients =18 years old treated with an open abdomen with a midline incision, regardless of indication.

Exclusion Criteria:

• 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

• Closure of the abdomen at first dressing change, e. g. without mesh traction

Related Conditions & MeSH terms

• Incisional Hernia
• Open Abdomen
• Temporary Abdominal Closure

Intervention

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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Skane University Hospital

References & Publications (1)

Petersson P, Montgomery A, Petersson U. Vacuum-Assisted Wound Closure and Permanent Onlay Mesh-Mediated Fascial Traction: A Novel Technique for the Prevention of Incisional Hernia after Open Abdomen Therapy Including Results From a Retrospective Case Series. Scand J Surg. 2019 Sep;108(3):216-226. doi: 10.1177/1457496918818979. Epub 2018 Dec 21. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incisional hernia at 1 year	Incidence of incisional hernia after open abdomen closure with the technique	1 year, year 1
Secondary	Fascial closure rate	Percentage of patients possible to closed with the technique	During hospital stay
Secondary	Complications	Complications related to the technique	Up to 12 weeks
Secondary	Incisional hernia	Incisional hernia incidence after three years	Through study completion, 3 years
Secondary	EQ5D	Patient reported outcome of generic quality of life	Through study completion, 3 years
Secondary	HERO	Patient reported outcome of abdominal wall function and discomfort	Through study completion, 3 years