NOVOsyn® for Trocar Incision After Laparoscopic Appendectomy and Cholecystectomy

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

316 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-02-13

Study Completion Date

2023-09-11

Brief Summary

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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).

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Detailed Description

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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

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Appendicitis Cholecystitis

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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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® CHD for fascia and skin closure

Intervention Type DEVICE

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.

Novosyn® for fascia and skin closure

Intervention Type DEVICE

Comparator

Interventions

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Novosyn® CHD for fascia and skin closure

Experimental

Intervention Type DEVICE

Novosyn® for fascia and skin closure

Comparator

Intervention Type DEVICE

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No