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Recruiting NCT07676370

PROV-MESH: Prophylactic Ovarian Cancer MESH

No phase Interventional Ovarian Cancer

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Prophylactic Mesh Placement, Negative Pressure Wound Therapy (NPWT), Standard Fascial Closure.
Who it may be relevant to
Registry conditions: Ovarian Cancer. Basic parameters: from 18 years · Female.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Spain
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

A Multicenter Randomized Clinical Trial Comparing Prophylactic Mesh Placement Versus Primary Closure, With or Without Negative Pressure Wound Therapy, in Patients Undergoing Primary or Interval Cytoreductive Surgery for Ovarian Cancer

Overview

Incisional hernia is a common complication after midline laparotomy and may significantly impact quality of life, morbidity, and healthcare costs. Patients undergoing cytoreductive surgery for ovarian cancer are considered at increased risk due to extensive surgical procedures, nutritional status, and exposure to systemic treatments. This prospective randomized clinical trial aims to evaluate whether prophylactic mesh placement during abdominal wall closure reduces the incidence of incisional hernia compared with conventional fascial closure in women undergoing cytoreductive surgery for ovarian cancer through a midline laparotomy. To control for the potential effect of negative pressure wound therapy (NPWT) on surgical site infection, participants will also be randomized to receive NPWT or standard wound dressing, resulting in four treatment arms.

Interventions

  • Procedure Prophylactic Mesh Placement
    Placement of a non-absorbable polypropylene or polyester mesh in a supra-aponeurotic position at the time of abdominal wall closure following cytoreductive surgery.
  • Device Negative Pressure Wound Therapy (NPWT)
    Application of a PICO negative pressure dressing after skin closure, maintained for 7 days postoperatively.
  • Procedure Standard Fascial Closure
    Continuous closure of the abdominal fascia using slowly absorbable monofilament suture (PDS 2-0), single-layer closure without peritoneal closure, maintaining a suture-to-wound length ratio greater than 4:1 and employing the small-bites technique.

Primary outcome measures

  • Incidence of Incisional Hernia [Time frame: 24 months after surgery]
Secondary outcome measures (3)
  • Incidence of Surgical Site Infection [Time frame: Within 30 days after surgery]
  • Incidence of Incisional Hernia at Intermediate Time Points [Time frame: 3, 6, and 12 months after surgery]
  • Risk Factors Associated With Incisional Hernia Development [Time frame: Up to 24 months]

Eligibility criteria

Inclusion criteria

  • Female patients diagnosed with ovarian carcinoma.
  • Undergoing primary cytoreductive surgery, interval cytoreductive surgery, or delayed cytoreductive surgery after six cycles of chemotherapy.
  • Surgical procedure performed through a midline laparotomy.
  • Ability and willingness to provide written informed consent.

Exclusion criteria

  • Surgery for recurrent ovarian cancer (secondary, tertiary, or subsequent cytoreductions).
  • Minimally invasive surgical approach.
  • Planned secondary cytoreductive surgery during the 24-month follow-up period.
  • Inability or unwillingness to comply with follow-up requirements.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Factorial
Masking
Open label
Primary purpose
Prevention

Study locations

Spain · 1 center
  • Hospital Universitario Vall d'Hebron — Barcelona

Identifiers

NCT: NCT07676370 · PI-24-055

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗