Clinical trial · Interventional
PROV-MESH: Prophylactic Ovarian Cancer MESH
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
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Ovarian Cancer | Malignant Ovarian Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Negative Pressure Wound Therapy (NPWT) | Device | — | UNRESOLVED |
| Prophylactic Mesh Placement | Procedure | — | UNRESOLVED |
| Standard Fascial Closure | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (4)
- type
- EXPERIMENTAL
- label
- Prophylactic Mesh + Negative Pressure Wound Therapy
- description
- Participants will undergo standard fascial closure reinforced with a prophylactic supra-aponeurotic non-absorbable mesh and postoperative negative pressure wound therapy using a PICO dressing for 7 days.
- interventionNames
- Procedure: Prophylactic Mesh Placement
- Device: Negative Pressure Wound Therapy (NPWT)
- type
- EXPERIMENTAL
- label
- Prophylactic Mesh without Negative Pressure Wound Therapy
- description
- Participants will undergo standard fascial closure reinforced with a prophylactic supra-aponeurotic non-absorbable mesh and standard postoperative wound dressing.
- interventionNames
- Procedure: Prophylactic Mesh Placement
- type
- ACTIVE_COMPARATOR
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available