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
Status: Recruiting
Location: See location...
Intervention Type: Procedure, Device
Study Type: Interventional
Study Phase: Not Applicable
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.
Eligibility
Participation Requirements
Sex: Female
Minimum Age: 18
Healthy Volunteers: f
View:
• 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.
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.
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.
Participants will undergo standard fascial closure without mesh reinforcement and postoperative negative pressure wound therapy using a PICO dressing for 7 days.
Experimental: Conventional Closure without Negative Pressure Wound Therapy
Participants will undergo standard fascial closure without mesh reinforcement and standard postoperative wound dressing.