PROV-MESH: Prophylactic Ovarian Cancer MESH (PROV-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

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.

Study Overview

• Status: Recruiting
• Conditions: Ovarian Cancer
• Intervention / Treatment: Procedure: Prophylactic Mesh Placement; Device: Negative Pressure Wound Therapy (NPWT); Procedure: Standard Fascial Closure

• Study Type: Interventional
• Enrollment (Estimated): 152
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Jose Luis Sánchez Iglesias, MD PhD; Phone Number: 3217 +34 932746000; Email: jlsanig@yahoo.es

Study Locations

• Spain
  • Barcelona
    • Barcelona, Barcelona, Spain, 08035
      • Recruiting
      • Hospital Universitario Vall d'Hebron
      • Contact: Jose Luis Sánchez Iglesias, MD PhD; Phone Number: 3217 +34 932746000; Email: jlsanig@yahoo.es

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Factorial Assignment
• Masking: None (Open Label)

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Prophylactic Mesh + Negative Pressure Wound Therapy; 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.	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.
Experimental: Prophylactic Mesh without Negative Pressure Wound Therapy; Participants will undergo standard fascial closure reinforced with a prophylactic supra-aponeurotic non-absorbable mesh and standard postoperative wound dressing.	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.
Active Comparator: Conventional Closure + Negative Pressure Wound Therapy; Participants will undergo standard fascial closure without mesh reinforcement and postoperative negative pressure wound therapy using a PICO dressing for 7 days.	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.
Experimental: Conventional Closure without Negative Pressure Wound Therapy; Participants will undergo standard fascial closure without mesh reinforcement and standard postoperative wound dressing.	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence of Incisional Hernia	Presence of an abdominal wall incisional hernia confirmed by computed tomography (CT scan) or by imaging performed after clinical suspicion during follow-up.	24 months after surgery

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence of Surgical Site Infection	Surgical site infection according to CDC criteria.	Within 30 days after surgery
Incidence of Incisional Hernia at Intermediate Time Points	Radiologically confirmed incisional hernia detected during routine follow-up imaging.	3, 6, and 12 months after surgery
Risk Factors Associated With Incisional Hernia Development	Identification of demographic, clinical, oncological, and surgical variables associated with incisional hernia occurrence.	Up to 24 months

Collaborators and Investigators

• Sponsor: Hospital Vall d'Hebron
• Collaborators: Germans Trias i Pujol Hospital; Hospital Universitario La Fe; Fundación Jimenez Diaz de Madrid

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2026
• Primary Completion (Estimated): December 31, 2028
• Study Completion (Estimated): December 31, 2030

Study Registration Dates

• First Submitted: June 24, 2026
• First Submitted That Met QC Criteria: June 24, 2026
• First Posted (Actual): June 30, 2026

Study Record Updates

• Last Update Posted (Actual): June 30, 2026
• Last Update Submitted That Met QC Criteria: June 24, 2026
• Last Verified: June 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Urogenital Diseases; Genital Diseases; Endocrine System Diseases; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Genital Diseases, Female; Endocrine Gland Neoplasms; Ovarian Diseases; Adnexal Diseases; Genital Neoplasms, Female; Gonadal Disorders; Ovarian Neoplasms; Therapeutics; Surgical Procedures, Operative; Drainage; Wound Closure Techniques; Negative-Pressure Wound Therapy
• Other Study ID Numbers: PI-24-055

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No