PROV-MESH: Prophylactic Ovarian Cancer MESH

NCT07676370 | Recruiting DMC

• 1 other identifier: PI-24-055
• Study Type: interventional
• Target: 152
• Locations: 1 country
• Sites: 1

Brief Summary

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

Ovarian Cancer

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Incidence of Surgical Site Infection

  Within 30 days after surgery

• Incidence of Incisional Hernia at Intermediate Time Points

  3, 6, and 12 months after surgery

• Risk Factors Associated With Incisional Hernia Development

  Up to 24 months

Study Arms (4)

Prophylactic Mesh + Negative Pressure Wound Therapy

EXPERIMENTAL

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; Device: Negative Pressure Wound Therapy (NPWT)

Prophylactic Mesh without Negative Pressure Wound Therapy

EXPERIMENTAL

Participants will undergo standard fascial closure reinforced with a prophylactic supra-aponeurotic non-absorbable mesh and standard postoperative wound dressing.

Procedure: Prophylactic Mesh Placement

Conventional Closure + Negative Pressure Wound Therapy

ACTIVE COMPARATOR

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); Procedure: Standard Fascial Closure

Conventional Closure without Negative Pressure Wound Therapy

EXPERIMENTAL

Participants will undergo standard fascial closure without mesh reinforcement and standard postoperative wound dressing.

Procedure: Standard Fascial Closure

Interventions

Negative Pressure Wound Therapy (NPWT) DEVICE

Application of a PICO negative pressure dressing after skin closure, maintained for 7 days postoperatively.

Conventional Closure + Negative Pressure Wound Therapy; Prophylactic Mesh + Negative Pressure Wound Therapy

Prophylactic Mesh Placement PROCEDURE

Placement of a non-absorbable polypropylene or polyester mesh in a supra-aponeurotic position at the time of abdominal wall closure following cytoreductive surgery.

Prophylactic Mesh + Negative Pressure Wound Therapy; Prophylactic Mesh without Negative Pressure Wound Therapy

Standard Fascial Closure PROCEDURE

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.

Conventional Closure + Negative Pressure Wound Therapy; Conventional Closure without Negative Pressure Wound Therapy

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Hospital Vall d'Hebron: lead
• Germans Trias i Pujol Hospital: collaborator
• Fundación Jimenez Diaz de Madrid: collaborator
• Hospital Universitario La Fe: collaborator

Study Sites (1)

Hospital Universitario Vall d'Hebron

Barcelona, Barcelona, 08035, Spain

RECRUITING

MeSH Terms

Conditions

Ovarian Neoplasms

Interventions

Negative-Pressure Wound Therapy

Condition Hierarchy (Ancestors)

Endocrine Gland Neoplasms; Neoplasms by Site; Neoplasms; Ovarian Diseases; Adnexal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Neoplasms, Female; Urogenital Neoplasms; Genital Diseases; Endocrine System Diseases; Gonadal Disorders

Intervention Hierarchy (Ancestors)

Drainage; Therapeutics; Surgical Procedures, Operative; Wound Closure Techniques

Central Study Contacts

Jose Luis Sánchez Iglesias, MD PhD

CONTACT

+34 932746000; jlsanig@yahoo.es

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD PhD

Study Record Dates

• First Submitted: June 24, 2026
• First Posted: June 30, 2026
• Study Start: January 1, 2026
• Primary Completion (Estimated): December 31, 2028
• Study Completion (Estimated): December 31, 2030
• Last Updated: June 30, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR

Locations

ES (1)