NOVOsyn® for Trocar Incision After Laparoscopic Appendectomy and Cholecystectomy (NOVOTILAC)

Aesculap

Status: Completed

Conditions: Cholecystitis; Appendicitis

Treatments: Device: Novosyn® for fascia and skin closure; Device: Novosyn® CHD for fascia and skin closure

Study type: Observational

Funder types: Industry

Identifiers

NCT04033211

AAG-O-H-1816

Details and patient eligibility

About

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).

Full 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.

Enrollment: 316 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

316 participants in 2 patient groups

Novosyn® CHD

Description:

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.

Treatment:

Device: Novosyn® CHD for fascia and skin closure

Novosyn®

Description:

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.

Treatment:

Device: Novosyn® for fascia and skin closure