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Clinical Trials/NL-OMON56300
NL-OMON56300
Recruiting
Phase 4

PREventing Surgical Site occurrences using negative pressURE wound therapy - The PRESSURE Trial

Academisch Medisch Centrum0 sites190 target enrollmentTBD
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Conditionsincisional herniaVentral abdominal wall hernia100000731000401810040795

Overview

Phase
Phase 4
Intervention
Not specified
Conditions
incisional hernia
Sponsor
Academisch Medisch Centrum
Enrollment
190
Status
Recruiting
Last Updated
2 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSimilar Trials

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
TBD
End Date
TBD
Last Updated
2 years ago
Study Type
Interventional

Investigators

Eligibility Criteria

Inclusion Criteria

  • •In order to participate in this trial, a subject must meet the following
  • •\>\=18 years
  • •Informed consent
  • •Pre\-operative CT available (\< 12 months of surgery)
  • •Scheduled for elective, open abdominal wall reconstruction\*, And one of the
  • •A stoma\*\* or enterocutaneous fistula and an abdominal wall defect\*\*\* of \>6
  • •cm\*\*\*\* on CT
  • •Violation of the gastrointestinal tract and an abdominal wall defect of \>6 cm
  • •Infected or exposed mesh (any size)
  • •Open abdomens with contamination\*\*\*\*\* (any size), \* Operative treatments

Exclusion Criteria

  • •Patients \<18
  • •Parastomal hernias planned for reconstruction using a local (or laparoscopic)
  • •approach without a laparotomy\*, \*In case of a patient scheduled for
  • •reconstruction of both incisional hernia and a parastomal hernia, the
  • •reconstruction of the incisional hernia will be eligible for randomization. If
  • •a parastomal hernia is approached through a laparotomy, the laparotomy incision
  • •will be eligible for randomization.

Outcomes

Primary Outcomes

Not specified

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