Ovarian CancerPROV-MESHNCT07676370
PROV-MESH: Prophylactic Ovarian Cancer MESH
A study testing Prophylactic Mesh Placement, Negative Pressure Wound Therapy (NPWT) and Standard Fascial Closure in people with Ovarian Cancer, run by Hospital Vall d'Hebron at 1 site in Spain.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Ovarian Cancer
- What is being tested?
- Prophylactic Mesh Placement, Negative Pressure Wound Therapy (NPWT) and Standard Fascial Closure
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 152 participants
- Where
- 1 siteSpain
- Study dates
- 1 Jan 2026to 31 Dec 2030
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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 locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Spain1 site, 1 recruiting
- Recruiting
Hospital Universitario Vall d'Hebron
Barcelona, Barcelona, 08035
Jose Luis Sánchez Iglesias, MD PhD, +34 932746000 ext. 3217, jlsanig@yahoo.es
About this study
Official 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
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
- Being tested
- Prophylactic Mesh Placement, Negative Pressure Wound Therapy (NPWT), Standard Fascial Closure
- Medical subject headings
- Ovarian Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Prophylactic Mesh PlacementProcedure or surgery
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 ClosureProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: 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. Receives: 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. Receives: Procedure: Standard Fascial Closure |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 24 months after surgery
Secondary outcomes (3)
Incidence of Surgical Site Infection
Surgical site infection according to CDC criteria.
Measured: Within 30 days after surgery
Incidence of Incisional Hernia at Intermediate Time Points
Radiologically confirmed incisional hernia detected during routine follow-up imaging.
Measured: 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.
Measured: Up to 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jun 2026
- Study start1 Jan 2026
- Primary completion31 Dec 2028 (estimated)
- Study completion31 Dec 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ovarian CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Enrolment
- 152 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hospital Vall d'Hebron
- Sponsor type
- University, hospital or other
- Collaborators
- Germans Trias i Pujol Hospital, Fundación Jimenez Diaz de Madrid, Hospital Universitario La Fe
- Responsible party
- Principal investigator, Jose Luis Sanchez, Hospital Vall d'Hebron
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07676370
- Sponsor's protocol ID
- PI-24-055
- Acronym
- PROV-MESH
- Status last verified
- Jun 2026
- First submitted
- 24 Jun 2026
- Last updated
- 30 Jun 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 30 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT07676370
- Acronym / sponsor ID
- PROV-MESH / PI-24-055
- Conditions
- Ovarian Cancer
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 152 participants (estimated)
- Lead sponsor
- Hospital Vall d'HebronUniversity, hospital or other
- Collaborators
- Germans Trias i Pujol Hospital, Fundación Jimenez Diaz de Madrid, Hospital Universitario La Fe
- Study start
- 1 Jan 2026 (actual)
- Primary completion
- 31 Dec 2028 (estimated)
- Study completion
- 31 Dec 2030 (estimated)
- First posted
- 30 Jun 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Prophylactic Mesh + Negative Pressure Wound Therapy | Experimental | Procedure: Prophylactic Mesh Placement, Device: Negative Pressure Wound Therapy (NPWT)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. |
| Prophylactic Mesh without Negative Pressure Wound Therapy | Experimental | Procedure: Prophylactic Mesh PlacementParticipants will undergo standard fascial closure reinforced with a prophylactic supra-aponeurotic non-absorbable mesh and standard postoperative wound dressing. |
| Conventional Closure + Negative Pressure Wound Therapy | Active comparator | Device: Negative Pressure Wound Therapy (NPWT), Procedure: Standard Fascial ClosureParticipants will undergo standard fascial closure without mesh reinforcement and postoperative negative pressure wound therapy using a PICO dressing for 7 days. |
| Conventional Closure without Negative Pressure Wound Therapy | Experimental | Procedure: Standard Fascial ClosureParticipants will undergo standard fascial closure without mesh reinforcement and standard postoperative wound dressing. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Prophylactic Mesh PlacementPlacement of a non-absorbable polypropylene or polyester mesh in a supra-aponeurotic position at the time of abdominal wall closure following cytoreductive surgery. | Procedure or surgery | Prophylactic Mesh + Negative Pressure Wound Therapy, Prophylactic Mesh without Negative Pressure Wound Therapy |
| Negative Pressure Wound Therapy (NPWT)Application of a PICO negative pressure dressing after skin closure, maintained for 7 days postoperatively. | Device | Conventional Closure + Negative Pressure Wound Therapy, Prophylactic Mesh + Negative Pressure Wound Therapy |
| Standard Fascial ClosureContinuous 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. | Procedure or surgery | Conventional Closure + Negative Pressure Wound Therapy, Conventional Closure without Negative Pressure Wound Therapy |
Primary outcome
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.
3 secondary outcomes
Incidence of Surgical Site Infection
Time frame: Within 30 days after surgery
Incidence of Incisional Hernia at Intermediate Time Points
Time frame: 3, 6, and 12 months after surgery
Risk Factors Associated With Incisional Hernia Development
Time frame: Up to 24 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jun 2026.
- Individual participant dataSharing planned: Yes
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Prophylactic Mesh Placement, Negative Pressure Wound Therapy (NPWT) and Standard Fascial Closure in people with Ovarian Cancer, run by Hospital Vall d'Hebron at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 30 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jose Luis Sánchez Iglesias, MD PhD (+34 932746000 ext. 3217, jlsanig@yahoo.es), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of Incisional Hernia (time frame: 24 months after surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Jun 2026.