NCT04033211

NOVOsyn® for Trocar Incision After Laparoscopic Appendectomy and Cholecystectomy

Randomized, Multi-center, Double Blinded, Prospective Study to Evaluate the Incidence of Complications in Laparoscopic Cholecystectomy and Appendectomy Using Novosyn® CHD Versus Novosyn® Suture Material to Close Trocar Wound

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 316 (actual)
• Sponsor: Aesculap AG · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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 the closure of trocar wounds in laparoscopic surgery (appendectomy and cholecystectomy).

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 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 assessment of SSI as set to 30 days postoperatively. Furthermore, short-term and long-term complications, the handling of the suture material, length of postoperative hospital stay, costs, pain, quality of life, time to return to work, hernia rate including umbilical hernias and the cosmetic outcome will also be assessed as secondary objectives.

Conditions

• Appendicitis
• Cholecystitis

Interventions

Type	Name	Description
DEVICE	Novosyn® CHD for fascia and skin closure	Experimental
DEVICE	Novosyn® for fascia and skin closure	Comparator

Timeline

• Start date: 2020-02-13
• Primary completion: 2022-08-24
• Completion: 2023-09-11
• First posted: 2019-07-26
• Last updated: 2025-06-18

Locations

4 sites across 2 countries: Germany, Spain