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310 081","Oriel.Mangadze@med.uni-heidelberg.de",{"name":639,"role":62,"phone":34,"phoneExt":34,"email":34},"Friedrich Kallinowski, Prof.",{"facility":641,"status":76,"city":642,"state":34,"zip":643,"country":596,"countryCode":597,"cosmosGeoPoint":644,"geoPoint":648,"contacts":649},"Bundeswehrzentralkrankenhaus Koblenz","Koblenz","56072",{"type":83,"coordinates":645},[646,647],7.57883,50.35357,{"lat":647,"lon":646},[650,654],{"name":651,"role":66,"phone":652,"phoneExt":34,"email":653},"Ute Vahid Dastgerdi","0049 261 281 550 01","UteVahidDastgerdi@bundeswehr.org",{"name":655,"role":62,"phone":34,"phoneExt":34,"email":34},"Sebastian Schaaf, MD",{"type":657,"investigatorFullName":34,"investigatorTitle":34,"investigatorAffiliation":34,"oldNameTitle":34,"oldOrganization":34},"SPONSOR","100355723",false,"NCT03911700","Prophylactic Reinforcement of Ventral Abdominal Incisions Trial","Prospective, Multi-Center, Open-Label, Randomized, Controlled Trial of Phasix™ Mesh to Prevent Incisional Hernia Subsequent to Open Midline Laparotomy","PREVENT","Inclusion Criteria:\n\n1. Must be ≥ 18 years of age\n2. Elective, open midline laparotomy ≥ 5 cm\n3. Willing and able to provide written informed consent\n4. Hernia risk equal to moderate or greater\n\nExclusion Criteria:\n\n1. Previous hernia repair\n2. Emergent surgery\n3. Creation of skin flaps is preplanned\n4. Preplanned 2nd surgery\n5. Active skin pathology\n6. Life expectancy less than 24 months\n7. Pregnant or planning to become pregnant\n8. Receiving a medication\u002Fmedical condition that may adversely affect wound healing\n9. ASA Class \\> IV\n10. Enrolled in another clinical trial\n11. Site personnel directly involved with this trial\n12. Any condition that would preclude the use of the device or the subject form completing the follow-up requirements\n13. Known or suspected allergy to tetracycline hydrochloride or kanamycin sulfate\n14. Two separate incisions are created\n15. Prior onlay mesh\n16. Surgeon is unable to fully close the fascia\n17. The surgery requires more than a single piece of mesh\n18. Contraindication to placement of mesh\n19. CDC Class IV\u002FActive Infection\n20. Breastfeeding","ALL","18 Years",{"count":668,"type":669},477,"ESTIMATED","INTERVENTIONAL",[672],"NA","This trial is being conducted to evaluate the efficacy of Phasix™ Mesh implantation at the time of midline fascial closure compared to primary suture closure in preventing a subsequent incisional hernia in subjects at risk for incisional hernia after open midline laparotomy surgery.",[675],"Open Midline Laparotomy","2026-06-10",{"date":678,"type":679},"2026-06-12","ACTUAL",{"date":681,"type":679},"2019-12-12",{"date":683,"type":669},"2031-12",{"name":5,"class":6},45]