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

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).

Study Overview

• Status: Completed
• Conditions: Cholecystitis; Appendicitis
• Intervention / Treatment: Device: Novosyn® CHD for fascia and skin closure; Device: Novosyn® for fascia and skin closure

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.

• Study Type: Observational
• Enrollment (Actual): 316

Contacts and Locations

Study Locations

• Germany
  • Baden-Württemberg
    • Leonberg, Baden-Württemberg, Germany, 71229
      • Klinikverbund Südwest Krankenhaus Leonberg Alllgemeinchirurgie
    • Schwäbisch Hall, Baden-Württemberg, Germany, 74523
      • Diakonie Klinikum gGmbH Schwäbisch Hall
• Spain
  • Badalona, Spain, 08916
    • Hospital Germans Trias i Pujol General and Digestive Surgery
  • Barcelona, Spain, 08006
    • General Surgery Department Hospital Plató

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• 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.

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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.	Device: Novosyn® CHD for fascia and skin closure; Experimental
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.	Device: Novosyn® for fascia and skin closure; Comparator

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Development of Wound Dehiscence	Incidence of wound dehiscence (skin) at different postoperative examinations	until discharge (ca. 10 days postop), 30 days +10 days and 1 year ±2 months postoperatively
Reoperation Rate	Incidence of reoperation rate at different postoperative times	until discharge (ca. 10 days postop), 30 days +10 days and 1 year ±2 months postoperatively
Mortality Rate	Incidence of mortality rate at different postoperative times	until discharge (ca. 10 days postop), 30 days +10 days, and 1 year ±2 months postoperatively
Postoperative Complications during the postoperative Course	Rates of postoperative complications such as bleeding, tissue reaction, abscess, perforation, bile leaks, biliary peritonitis, ileus, stenosis, fistula at different postoperative points in time	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	Rate of suture removal due to wound problems (infection, dehiscence, residual material requiring removal) at different defined postoperative points in time	until discharge (ca. 10 days postop), 30 days +10 days, and 1 year ±2 months postoperatively
Length of hospital stay	Defined as the time period from day of operation until day of discharge (efficacy parameter).	until discharge (ca. 10 days postop)
Postoperative Surgical Site Infections	Incidence of postoperative surgical site infections	1 year ±2 months post-op
Rate of Conversion to open surgery	Number of interventions where operation technique has to be converted to open surgery intraoperatively	intraoperatively
Time to return to work	Defined as the duration (days) from day of surgery until the day when the patient was able to work. Employment status of the patient will also be reported.	up to 1 year ±2 months
Course of Pain: Visual Analogue Scale (VAS)	This parameter will be noted using the Visual Analogue Scale (VAS) which state "0" at one end representing "no pain" and "100" at the opposite end representing "maximal pain". The values are compared over postoperative period.	preoperatively, at day of discharge (ca. 10 days postop), at 30 days +10 days and 1 year ±2 months postoperatively
Course of Cosmetic result	Overall patient and observer satisfaction with the scar using the Patient and Observer Scar Assessment Scale (POSAS). Cosmetic result and the scar will be evaluated by the patient and the physician. Patient will rate the cosmetic outcome in six categories (Pain, Itching, Color of scar, Stiffness of scar, thickness and irregularity of scar) on a 1 to 10 points scale each. The physician will use the Observer component, rating vascularization, pigmentation, thickness, relief and pliability of the scar on a 1 to 10 points scale each. The categories are added to a total POSAS score of 11 (minimum) to 110 points (maximum)	30 days +10 days, 1 year ±2 months postoperatively
Course of Overall patient and observer satisfaction with the scar: Patient and Observer Scar Assessment Scale (POSAS)	Overall patient and observer satisfaction with the scar using the Patient and Observer Scar Assessment Scale (POSAS). Cosmetic result and the scar will be evaluated by the patient and the physician. Patient will rate the cosmetic outcome in six categories (Pain, Itching, Color of scar, Stiffness of scar, thickness and irregularity of scar) on a 1 to 10 points scale each. The physician will use the Observer component, rating vascularization, pigmentation, thickness, relief and pliability of the scar on a 1 to 10 points scale each. The categories are added to a total POSAS score of 11 (minimum) to 110 points (maximum)	30 days +10 day, 1 year ±2 months postoperatively
Comparison of wound appearance	Photographic documentation of the wounds for assessment	discharge (ca. 10 days postop), 30 days +10 days and 1 year ±2 months postoperatively
Comparison of handling parameters of the suture materials	Comparison of the handling features of the suture materials in eight different categories (ease of passage of the suture, first throw knot holding, knot tie down smoothness, knot security, surgical hand, memory effect, lack of frying and the overall handling) by rating each category on a 5 point scale (excellent, very good, good, satisfied, poor); no overall score is calculated, the categories are compared separately	intraoperatively
Course of Health Status	EQ-5D is a standardised measure of health status developed by EuroQol Group in order to provide a simple, generic measure of health for clinical and economic appraisal. EQ-5D is designed for self-completion by respondents and it takes only a few minutes to complete. Instructions to respondents are included in the questionnaire. EQ-5D-5L consists of 2 pages - descriptive system and the EQ visual Analogue scale (EQ-VAS). The descriptive system comprises 5 dimensions (mobility, self care, usual activities, pain/discomfort, anxiety/depression). Each dimension has 5 levels: no problems, slight problems, moderate problems, severe problems and extreme problems. The EQ VAS records the respondents self rated health on a 20 cm vertical , visual analogue scale with endpoints labelled "the best health you can imagine" and " the worst health you can imagine"	30 days +10 days after surgery, 1 year ±2 months after surgery
Hernia Rate / Umbilical Hernia Rate	Hernia rate including umbilical hernia postoperatively verified by ultra-sound examination compared at different postoperative points in time	until discharge (ca. 10 days postop), 30 days +10 days, 1 year ±2 months postoperatively
Costs (economics)	Assessment of costs will be calculated on postoperative complication (SSI) in both suture groups (efficient parameter).	1 year ±2 months

Collaborators and Investigators

• Sponsor: Aesculap AG
• Collaborators: B.Braun Surgical SA
• Investigators: Principal Investigator: Markus Golling, Prof. Dr., Diakonie Klinikum gGmbH Schwäbisch Hall

Study record dates

Study Major Dates

• Study Start (Actual): February 13, 2020
• Primary Completion (Actual): August 24, 2022
• Study Completion (Actual): September 11, 2023

Study Registration Dates

• First Submitted: July 4, 2019
• First Submitted That Met QC Criteria: July 25, 2019
• First Posted (Actual): July 26, 2019

Study Record Updates

• Last Update Posted (Actual): September 28, 2023
• Last Update Submitted That Met QC Criteria: September 26, 2023
• Last Verified: September 1, 2023

More Information

Terms related to this study

• Keywords: Cholecystectomy; Appendectomy; Minimal invasive surgery
• Additional Relevant MeSH Terms: Digestive System Diseases; Infections; Gastrointestinal Diseases; Gastroenteritis; Intestinal Diseases; Gallbladder Diseases; Biliary Tract Diseases; Cecal Diseases; Intraabdominal Infections; Cholecystitis; Appendicitis
• Other Study ID Numbers: AAG-O-H-1816

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No