PROV-MESH: Prophylactic Ovarian Cancer MESH

Catalan Institute of Health

Status: Enrolling

Conditions: Ovarian Cancer

Treatments: Procedure: Prophylactic Mesh Placement; Device: Negative Pressure Wound Therapy (NPWT); Procedure: Standard Fascial Closure

Study type: Interventional

Funder types: Other

Identifiers

NCT07676370

PI-24-055

Details and patient eligibility

About

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.

Enrollment: 152 estimated patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Factorial Assignment

Masking: None (Open label)

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152 participants in 4 patient groups

Prophylactic Mesh + Negative Pressure Wound Therapy

Experimental group

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.

Treatment:

Device: Negative Pressure Wound Therapy (NPWT)

Procedure: Prophylactic Mesh Placement

Prophylactic Mesh without Negative Pressure Wound Therapy

Experimental group

Description:

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

Treatment:

Procedure: Prophylactic Mesh Placement

Conventional Closure + Negative Pressure Wound Therapy

Active Comparator group

Description:

Participants will undergo standard fascial closure without mesh reinforcement and postoperative negative pressure wound therapy using a PICO dressing for 7 days.

Treatment:

Procedure: Standard Fascial Closure

Device: Negative Pressure Wound Therapy (NPWT)

Conventional Closure without Negative Pressure Wound Therapy

Experimental group

Description:

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

Treatment:

Procedure: Standard Fascial Closure