NOVOsyn® for Trocar Incision After Laparoscopic Appendectomy and Cholecystectomy
NOVOTILAC
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
1 other identifier
observational
316
2 countries
4
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 the closure of trocar wounds in laparoscopic surgery (appendectomy and cholecystectomy).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Feb 2020
Typical duration for all trials
4 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 4, 2019
CompletedFirst Posted
Study publicly available on registry
July 26, 2019
CompletedStudy Start
First participant enrolled
February 13, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 24, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
September 11, 2023
CompletedJune 18, 2025
June 1, 2025
2.5 years
July 4, 2019
June 16, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Surgical Site Infection
Incidence of postoperative surgical site infections, SSI (A1: Superficial incisional site infections and A2: Deep incisional surgical site infections) (efficacy parameter) Surgical Site Infection (SSI) is defined according to the definition of the US Centres for Disease Control and Prevention (CDC).
until 30 days + 10 days after surgery
Secondary Outcomes (17)
Development of Wound Dehiscence
until discharge (ca. 10 days postop), 30 days +10 days and 1 year ±2 months postoperatively
Reoperation Rate
until discharge (ca. 10 days postop), 30 days +10 days and 1 year ±2 months postoperatively
Mortality Rate
until discharge (ca. 10 days postop), 30 days +10 days, and 1 year ±2 months postoperatively
Postoperative Complications during the postoperative Course
until discharge (ca. 10 days postop), 30 days +10 days, 1 year ±2 months postoperatively
Suture Removal due to Wound Problems during the postoperative Course
until discharge (ca. 10 days postop), 30 days +10 days, and 1 year ±2 months postoperatively
- +12 more secondary outcomes
Study Arms (2)
Novosyn® CHD
A population undergoing a primary emergency or early elective (24h - 7 days) laparoscopic appendectomy or a primary emergency or early elective laparoscopic cholecystectomy using Novosyn® CHD suture for fascia and skin closure of trocar wounds.
Novosyn®
A population undergoing a primary emergency or early elective (24h - 7 days) laparoscopic appendectomy or a primary emergency or early elective laparoscopic cholecystectomy using either Novosyn® suture for fascia and skin closure of trocar wounds.
Interventions
Eligibility Criteria
A population undergoing a primary emergency or early elective (24h - 7 days) laparoscopic appendectomy or a primary emergency or early elective laparoscopic cholecystectomy using either Novosyn® CHD or Novosyn® suture for fascia and skin closure of trocar wounds.
You may qualify if:
- Patients undergoing a primary emergency or early elective (24h - 7 days) laparoscopic appendectomy or cholecystectomy.
- Written informed consent
- Age≥ 18 years
- Not incapacitated patient
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Aesculap AGlead
- B.Braun Surgical SAcollaborator
Study Sites (4)
Klinikverbund Südwest Krankenhaus Leonberg Alllgemeinchirurgie
Leonberg, Baden-Wurttemberg, 71229, Germany
Diakonie Klinikum gGmbH Schwäbisch Hall
Schwäbisch Hall, Baden-Wurttemberg, 74523, Germany
Hospital Germans Trias i Pujol General and Digestive Surgery
Badalona, 08916, Spain
General Surgery Department Hospital Plató
Barcelona, 08006, Spain
Related Publications (1)
Golling MT, Breul V, Barongo S, Milosheski T, Rubio JC, Pinedo AZ, Hoyuela C, Hidalgo NJ, Steurer W, Baumann P. Chlorhexidine - coated vs non-coated Suture to prevent surgical site infections following laparoscopic abdominal surgery (a prospective, randomized, controlled trial; NOVOTILAC). Langenbecks Arch Surg. 2025 Jun 13;410(1):191. doi: 10.1007/s00423-025-03757-x.
PMID: 40512393RESULT
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Markus Golling, Prof. Dr.
Diakonie Klinikum gGmbH Schwäbisch Hall
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 4, 2019
First Posted
July 26, 2019
Study Start
February 13, 2020
Primary Completion
August 24, 2022
Study Completion
September 11, 2023
Last Updated
June 18, 2025
Record last verified: 2025-06
Data Sharing
- IPD Sharing
- Will not share