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Search / Trial NCT04033211

NOVOsyn® for Trocar Incision After Laparoscopic Appendectomy and Cholecystectomy

Launched by AESCULAP AG · Jul 25, 2019

Trial Information

Current as of May 18, 2025

Completed

Keywords

Minimal Invasive Surgery Appendectomy Cholecystectomy

ClinConnect Summary

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 infections (SSI: A1 and A2) is considered as a suitable parameter for the assessment of efficacy. It is expected that the use of the Novosyn® CHD suture will reduce the occurrence of infections (SSI: A1 and A2) 30 days postoperatively compared to Novosyn suture (primary objective). SSI will be classified according to the Centre of Disease Control and Prevention (CDC), therefore the time point for as...

Gender

ALL

Eligibility criteria

  • Inclusion Criteria:
  • 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 Criteria:
  • 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

About Aesculap Ag

Aesculap AG is a prominent global medical device manufacturer specializing in surgical instruments, implants, and innovative healthcare solutions. With a rich history rooted in excellence and innovation, Aesculap AG is dedicated to advancing surgical practices through cutting-edge technology and a commitment to improving patient outcomes. The company collaborates with healthcare professionals and institutions to conduct clinical trials that evaluate the safety and efficacy of its products, ensuring that they meet the highest standards of quality and performance. Through its rigorous research and development initiatives, Aesculap AG aims to contribute significantly to the field of medicine and enhance the standards of surgical care worldwide.

Locations

Leonberg, Baden Württemberg, Germany

Schwäbisch Hall, Baden Württemberg, Germany

Badalona, , Spain

Barcelona, , Spain

Sevilla, , Spain

Patients applied

0 patients applied

Trial Officials

Markus Golling, Prof. Dr.

Principal Investigator

Diakonie Klinikum gGmbH Schwäbisch Hall

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

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