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NCT Number: NCT05568238

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

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.

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Key information

Who can participate

Healthy volunteers accepted: No

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

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

Treatment and study plan

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

Procedure

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

Primary outcomes

  1. Incisional hernia at 1 year

    Time frame: 1 year, year 1

    Incidence of incisional hernia after open abdomen closure with the technique

Secondary outcomes

  1. Fascial closure rate

    Time frame: During hospital stay

    Percentage of patients possible to closed with the technique

  2. Complications

    Time frame: Up to 12 weeks

    Complications related to the technique

  3. Incisional hernia

    Time frame: Through study completion, 3 years

    Incisional hernia incidence after three years

  4. EQ5D

    Time frame: Through study completion, 3 years

    Patient reported outcome of generic quality of life

  5. HERO

    Time frame: Through study completion, 3 years

    Patient reported outcome of abdominal wall function and discomfort

Study contacts

Contact information is provided by the study sponsor or research team.

Peder Rogmark, MD, PhD

CONTACT

[email protected]

+46 40 333398

Ulf Pettersson, Ass prof

CONTACT

[email protected]

+46705657446

Sponsors and collaborators

Lead sponsor

Skane University Hospital

Other

Registry information

Official study 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

Acronym: VAWCPOM

Important dates

Study start
2022
Primary completion
2024
Study completion
2027
First posted
Oct 5, 2022
Registry last updated
Oct 5, 2022

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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