Clinical trial NCT04033211: NOVOsyn® for Trocar Incision After Laparoscopic Appendectomy and Cholecystectomy
Official title: 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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Appendicitis
Cholecystitis
Keywords: Minimal invasive surgery
Appendectomy
Cholecystectomy
Lead sponsor: Aesculap AG
Sponsor class: INDUSTRY
Collaborators: name: B.Braun Surgical SA
First posted: 2019-07-26
Enrollment: 316
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: 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.

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).

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.

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

Primary outcomes:
measure: Surgical Site Infection
timeFrame: until 30 days + 10 days after surgery
Secondary outcomes:
measure: Development of Wound Dehiscence
timeFrame: until discharge (ca. 10 days postop), 30 days +10 days and 1 year ±2 months postoperatively
measure: Reoperation Rate
timeFrame: until discharge (ca. 10 days postop), 30 days +10 days and 1 year ±2 months postoperatively
measure: Mortality Rate
timeFrame: until discharge (ca. 10 days postop), 30 days +10 days, and 1 year ±2 months postoperatively
measure: Postoperative Complications during the postoperative Course
timeFrame: until discharge (ca. 10 days postop), 30 days +10 days, 1 year ±2 months postoperatively
measure: Suture Removal due to Wound Problems during the postoperative Course
timeFrame: until discharge (ca. 10 days postop), 30 days +10 days, and 1 year ±2 months postoperatively
measure: Length of hospital stay
timeFrame: until discharge (ca. 10 days postop)
measure: Postoperative Surgical Site Infections
timeFrame: 1 year ±2 months post-op
measure: Rate of Conversion to open surgery
timeFrame: intraoperatively
measure: Time to return to work
timeFrame: up to 1 year ±2 months
measure: Course of Pain: Visual Analogue Scale (VAS)
timeFrame: preoperatively, at day of discharge (ca. 10 days postop), at 30 days +10 days and 1 year ±2 months postoperatively
measure: Course of Cosmetic result
timeFrame: 30 days +10 days, 1 year ±2 months postoperatively
measure: Course of Overall patient and observer satisfaction with the scar: Patient and Observer Scar Assessment Scale (POSAS)
timeFrame: 30 days +10 day, 1 year ±2 months postoperatively
measure: Comparison of wound appearance
timeFrame: discharge (ca. 10 days postop), 30 days +10 days and 1 year ±2 months postoperatively
measure: Comparison of handling parameters of the suture materials
timeFrame: intraoperatively
measure: Course of Health Status
timeFrame: 30 days +10 days after surgery, 1 year ±2 months after surgery
measure: Hernia Rate / Umbilical Hernia Rate
timeFrame: until discharge (ca. 10 days postop), 30 days +10 days, 1 year ±2 months postoperatively
measure: Costs (economics)
timeFrame: 1 year ±2 months
Other outcomes:
Locations:
city: Leonberg
country: Germany
facility: Klinikverbund Südwest Krankenhaus Leonberg Alllgemeinchirurgie
state: Baden-Württemberg
city: Schwäbisch Hall
country: Germany
facility: Diakonie Klinikum gGmbH Schwäbisch Hall
state: Baden-Württemberg
city: Badalona
country: Spain
facility: Hospital Germans Trias i Pujol General and Digestive Surgery
city: Barcelona
country: Spain
facility: General Surgery Department Hospital Plató
Study officials:
affiliation: Diakonie Klinikum gGmbH Schwäbisch Hall
name: Markus Golling, Prof. Dr.
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.