Status:
COMPLETED
NOVOsyn® for Trocar Incision After Laparoscopic Appendectomy and Cholecystectomy
Lead Sponsor:
Aesculap AG
Collaborating Sponsors:
B.Braun Surgical SA
Conditions:
Appendicitis
Cholecystitis
Eligibility:
All Genders
18+ years
Brief Summary
The aim of this study is to evaluate if the application of a Chlorhexidine coated suture (Novosyn® CHD) will reduce the colonization of bacteria in comparison to an uncoated suture (Novosyn®) used for...
Detailed Description
The bacteriostatic and bactericidal effect of Novosyn® CHD will be assessed by the incidence of surgical site infection (SSI) in each suture group until 30 days postoperatively. The frequency of infec...
Eligibility Criteria
Inclusion
- Patients undergoing a primary emergency or early elective (24h - 7 days) laparoscopic appendectomy or cholecystectomy.
- Written informed consent
- Age≥ 18 years
- Not incapacitated patient
Exclusion
- Open surgery for appendectomy or cholecystectomy
- Pregnancy
- Allergy or hypersensitivity to chlorhexidine
- Intraoperatively conversion from laparoscopic to open surgery
- Patients taking medical consumption that might affect wound healing
Key Trial Info
Start Date :
February 13 2020
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
September 11 2023
Estimated Enrollment :
316 Patients enrolled
Trial Details
Trial ID
NCT04033211
Start Date
February 13 2020
End Date
September 11 2023
Last Update
June 18 2025
Active Locations (4)
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1
Klinikverbund Südwest Krankenhaus Leonberg Alllgemeinchirurgie
Leonberg, Baden-Wurttemberg, Germany, 71229
2
Diakonie Klinikum gGmbH Schwäbisch Hall
Schwäbisch Hall, Baden-Wurttemberg, Germany, 74523
3
Hospital Germans Trias i Pujol General and Digestive Surgery
Badalona, Spain, 08916
4
General Surgery Department Hospital Plató
Barcelona, Spain, 08006