AppendicitisNOVOTILACNCT04033211
NOVOsyn® for Trocar Incision After Laparoscopic Appendectomy and Cholecystectomy
An observational study of Appendicitis and Cholecystitis, run by Aesculap AG at 4 sites in 2 countries.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Appendicitis, Cholecystitis
- What is being tested?
- Novosyn® CHD for fascia and skin closure and Novosyn® for fascia and skin closure
- Type of treatment
- Medical device
- How many people
- 316 participants
- Where
- 4 sitesin 2 countries
- Study dates
- 13 Feb 2020to 11 Sep 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- Patients undergoing a primary emergency or early elective (24h - 7 days) laparoscopic appendectomy or cholecystectomy.
- Written informed consent
- Age≥ 18 years
- Not incapacitated patient
Who cannot join
- 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 locations and contacts
4 sites in 2 countries.
4 sites in 2 countries
Germany2 sites
Klinikverbund Südwest Krankenhaus Leonberg Alllgemeinchirurgie
Leonberg, Baden-Wurttemberg, 71229
Diakonie Klinikum gGmbH Schwäbisch Hall
Schwäbisch Hall, Baden-Wurttemberg, 74523
Spain2 sites
Hospital Germans Trias i Pujol General and Digestive Surgery
Badalona, 08916
General Surgery Department Hospital Plató
Barcelona, 08006
About this study
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
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).
Read the 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.
- Conditions
- Appendicitis, Cholecystitis
- Being tested
- Novosyn® CHD for fascia and skin closure, Novosyn® for fascia and skin closure
- Keywords
- Minimal invasive surgery, Appendectomy, Cholecystectomy
- Medical subject headings
- Appendicitis, Cholecystitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Novosyn® CHD for fascia and skin closureDevice
Experimental
Novosyn® for fascia and skin closureDevice
Comparator
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: Novosyn® CHD for fascia and skin closure | |
| 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. Receives: Device: Novosyn® for fascia and skin closure |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: until 30 days + 10 days after surgery
Secondary outcomes (17)
Development of Wound Dehiscence
Incidence of wound dehiscence (skin) at different postoperative examinations
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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).
Measured: until discharge (ca. 10 days postop)
Postoperative Surgical Site Infections
Incidence of postoperative surgical site infections
Measured: 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
Measured: 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.
Measured: 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.
Measured: 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)
Measured: 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)
Measured: 30 days +10 day, 1 year ±2 months postoperatively
Comparison of wound appearance
Photographic documentation of the wounds for assessment
Measured: 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
Measured: 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"
Measured: 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
Measured: 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).
Measured: 1 year ±2 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jul 2019
- Study start13 Feb 2020
- Primary completion24 Aug 2022
- Study completion11 Sep 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for AppendicitisStudies of the same condition, open and under way.
- More trials run by Aesculap AGThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 316 participants (actual)
Sponsor and investigators
- Lead sponsor
- Aesculap AG
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- B.Braun Surgical SA
- Responsible party
- Sponsor
- Investigators
- Markus Golling, Prof. Dr., Principal investigator, Diakonie Klinikum gGmbH Schwäbisch Hall
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04033211
- Sponsor's protocol ID
- AAG-O-H-1816
- Acronym
- NOVOTILAC
- Status last verified
- Jun 2025
- First submitted
- 4 Jul 2019
- Last updated
- 18 Jun 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 40512393
Study at a glance
From the registry record, last updated by the sponsor on 18 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04033211
- Acronym / sponsor ID
- NOVOTILAC / AAG-O-H-1816
- Conditions
- Appendicitis, Cholecystitis
- Keywords
- Minimal invasive surgery, Appendectomy, Cholecystectomy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 316 participants (actual)
- Lead sponsor
- Aesculap AGIndustry (pharma, biotech, devices)
- Collaborators
- B.Braun Surgical SA
- Study start
- 13 Feb 2020 (actual)
- Primary completion
- 24 Aug 2022 (actual)
- Study completion
- 11 Sep 2023 (actual)
- First posted
- 26 Jul 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Novosyn® CHD | – | Device: Novosyn® CHD for fascia and skin closureA 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® | – | Device: Novosyn® for fascia and skin closureA 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (4 listed)
- Patients undergoing a primary emergency or early elective (24h - 7 days) laparoscopic appendectomy or cholecystectomy.
- Written informed consent
- Age≥ 18 years
- Not incapacitated patient
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Novosyn® CHD for fascia and skin closureExperimental | Device | Novosyn® CHD |
| Novosyn® for fascia and skin closureComparator | Device | Novosyn® |
Primary outcome
Surgical Site Infection
Time frame: until 30 days + 10 days after surgery
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).
17 secondary outcomes
Development of Wound Dehiscence
Time frame: until discharge (ca. 10 days postop), 30 days +10 days and 1 year ±2 months postoperatively
Reoperation Rate
Time frame: until discharge (ca. 10 days postop), 30 days +10 days and 1 year ±2 months postoperatively
Mortality Rate
Time frame: until discharge (ca. 10 days postop), 30 days +10 days, and 1 year ±2 months postoperatively
Postoperative Complications during the postoperative Course
Time frame: 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
Time frame: until discharge (ca. 10 days postop), 30 days +10 days, and 1 year ±2 months postoperatively
Length of hospital stay
Time frame: until discharge (ca. 10 days postop)
Postoperative Surgical Site Infections
Time frame: 1 year ±2 months post-op
Rate of Conversion to open surgery
Time frame: intraoperatively
Time to return to work
Time frame: up to 1 year ±2 months
Course of Pain: Visual Analogue Scale (VAS)
Time frame: preoperatively, at day of discharge (ca. 10 days postop), at 30 days +10 days and 1 year ±2 months postoperatively
Course of Cosmetic result
Time frame: 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)
Time frame: 30 days +10 day, 1 year ±2 months postoperatively
Comparison of wound appearance
Time frame: discharge (ca. 10 days postop), 30 days +10 days and 1 year ±2 months postoperatively
Comparison of handling parameters of the suture materials
Time frame: intraoperatively
Course of Health Status
Time frame: 30 days +10 days after surgery, 1 year ±2 months after surgery
Hernia Rate / Umbilical Hernia Rate
Time frame: until discharge (ca. 10 days postop), 30 days +10 days, 1 year ±2 months postoperatively
Costs (economics)
Time frame: 1 year ±2 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jun 2025.
- Results publication: PubMed 40512393Golling 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.
- Related InfoLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Markus Golling, Prof. Dr. principal investigator
Diakonie Klinikum gGmbH Schwäbisch Hall
4 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Appendicitis and Cholecystitis, run by Aesculap AG at 4 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in Germany, Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Surgical Site Infection (time frame: until 30 days + 10 days after surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04033211, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Jun 2025.