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Novosyn® CHD vs Polyglactin 910 Suture to Close Wounds After Emergency or Elective Laparotomy or Laparoscopic Surgery
Sponsor: Aesculap AG
Summary
The aim of the study is to elucidate, if the colonization of bacteria is lower on the Novosyn® CHD suture compared to uncoated Polyglactin 910 suture, which will be assessed by the incidence of surgical site infections (SSI: A1 and A2). The results of this registry will generate further clinical evidence for the use and the benefit of a Chlorhexidine coated suture used to close the wound after an emergency or elective laparoscopic or laparotomy surgery. The benefit for individual patients lies in the early diagnosis of complications and in the optimized postoperative controls of a clinical study.
Official title: 'All Comer'/'Real-world' Registry-based Randomized, Prospective, Multicenter Clinical Trial to Evaluate the Incidence of Complications Using Novosyn® CHD Suture Versus Polyglactin 910 Suture to Close the Wound After Emergency or Elective Laparotomy or Laparoscopic Surgery
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
OBSERVATIONAL
Enrollment
2998
Start Date
2023-09-18
Completion Date
2028-12
Last Updated
2026-03-06
Healthy Volunteers
No
Conditions
Interventions
Novosyn® in emergency or elective laparotomy or laparoscopic surgery
Fascia closure (and subcutaneous closure if applicable) after emergency or elective laparotomy or laparoscopic surgery.
Polyglactin 910 in emergency or elective laparotomy or laparoscopic surgery
Fascia closure (and subcutaneous closure if applicable) after emergency or elective laparotomy or laparoscopic surgery.
Locations (4)
Pineta Grande Hospital
Naples, Italy
Hospital Clínico San Carlos
Madrid, Spain
Hospital Universitario de Canarias
Santa Cruz de Tenerife, Spain
Hospital Universitario Virgen del Rocío
Seville, Spain