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NCT Number: NCT07676370

PROV-MESH: Prophylactic Ovarian Cancer MESH

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.

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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Hospital Universitario Vall d'Hebron

Barcelona, 08035, Spain

Location status: Recruiting

Location contact

Jose Luis Sánchez Iglesias, MD PhD

CONTACT

[email protected]

+34 932746000 ext. 3217

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Negative Pressure Wound Therapy (NPWT)

Device

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

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.

Primary outcomes

  1. Incidence of Incisional Hernia

    Time frame: 24 months after surgery

    Presence of an abdominal wall incisional hernia confirmed by computed tomography (CT scan) or by imaging performed after clinical suspicion during follow-up.

Secondary outcomes

  1. Incidence of Surgical Site Infection

    Time frame: Within 30 days after surgery

    Surgical site infection according to CDC criteria.

  2. Incidence of Incisional Hernia at Intermediate Time Points

    Time frame: 3, 6, and 12 months after surgery

    Radiologically confirmed incisional hernia detected during routine follow-up imaging.

  3. Risk Factors Associated With Incisional Hernia Development

    Time frame: Up to 24 months

    Identification of demographic, clinical, oncological, and surgical variables associated with incisional hernia occurrence.

Study contacts

Contact information is provided by the study sponsor or research team.

Jose Luis Sánchez Iglesias, MD PhD

CONTACT

[email protected]

+34 932746000 ext. 3217

Sponsors and collaborators

Lead sponsor

Hospital Vall d'Hebron

Other

Collaborators

  • Fundación Jimenez Diaz de Madrid
  • Germans Trias i Pujol Hospital
  • Hospital Universitario La Fe

Registry information

Official study 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

Acronym: PROV-MESH

Important dates

Study start
2026
Primary completion
2028
Study completion
2030
First posted
Jun 30, 2026
Registry last updated
Jun 30, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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