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

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ClinicalTrials.gov Identifier: NCT04033211
Recruitment Status : Not yet recruiting
First Posted : July 26, 2019
Last Update Posted : July 29, 2019
Sponsor:
Collaborator:
B.Braun Surgical SA
Information provided by (Responsible Party):
Aesculap AG

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).

Condition or disease Intervention/treatment
Appendicitis Cholecystitis 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.


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Study Type : Observational
Estimated Enrollment : 282 participants
Observational Model: Cohort
Time Perspective: Prospective
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
Estimated Study Start Date : September 2019
Estimated Primary Completion Date : October 2020
Estimated Study Completion Date : December 2021

Resource links provided by the National Library of Medicine


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




Primary Outcome Measures :
  1. 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).


Secondary Outcome Measures :
  1. Development of Wound Dehiscence [ Time Frame: until discharge (ca. 10 days postop), 30 days +10 days and 1 year ±2 months postoperatively ]
    Incidence of wound dehiscence (skin) at different postoperative examinations

  2. Reoperation Rate [ Time Frame: until discharge (ca. 10 days postop), 30 days +10 days and 1 year ±2 months postoperatively ]
    Incidence of reoperation rate at different postoperative times

  3. Mortality Rate [ Time Frame: until discharge (ca. 10 days postop), 30 days +10 days, and 1 year ±2 months postoperatively ]
    Incidence of mortality rate at different postoperative times

  4. Postoperative Complications during the postoperative Course [ Time Frame: until discharge (ca. 10 days postop), 30 days +10 days, 1 year ±2 months postoperatively ]
    Rates of postoperative complications such as bleeding, tissue reaction, abscess, perforation, bile leaks, biliary peritonitis, ileus, stenosis, fistula at different postoperative points in time

  5. 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 ]
    Rate of suture removal due to wound problems (infection, dehiscence, residual material requiring removal) at different defined postoperative points in time

  6. Length of hospital stay [ Time Frame: until discharge (ca. 10 days postop) ]
    Defined as the time period from day of operation until day of discharge (efficacy parameter).

  7. Postoperative Surgical Site Infections [ Time Frame: 1 year ±2 months post-op ]
    Incidence of postoperative surgical site infections

  8. Rate of Conversion to open surgery [ Time Frame: intraoperatively ]
    Number of interventions where operation technique has to be converted to open surgery intraoperatively

  9. Time to return to work [ Time Frame: up to 1 year ±2 months ]
    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.

  10. 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 ]
    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.

  11. Course of Cosmetic result [ Time Frame: 30 days +10 days, 1 year ±2 months postoperatively ]
    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)

  12. 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 ]
    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)

  13. Comparison of wound appearance [ Time Frame: discharge (ca. 10 days postop), 30 days +10 days and 1 year ±2 months postoperatively ]
    Photographic documentation of the wounds for assessment

  14. Comparison of handling parameters of the suture materials [ Time Frame: intraoperatively ]
    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

  15. Course of Health Status [ Time Frame: 30 days +10 days after surgery, 1 year ±2 months after surgery ]
    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"

  16. Hernia Rate / Umbilical Hernia Rate [ Time Frame: until discharge (ca. 10 days postop), 30 days +10 days, 1 year ±2 months postoperatively ]
    Hernia rate including umbilical hernia postoperatively verified by ultra-sound examination compared at different postoperative points in time

  17. Costs (economics) [ Time Frame: 1 year ±2 months ]
    Assessment of costs will be calculated on postoperative complication (SSI) in both suture groups (efficient parameter).



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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.
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04033211


Contacts
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Contact: Petra Baumann, Dr. +49-7461-95-0 ext 1646 petra.baumann@aesculap.de

Locations
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Germany
Diakonie Klinikum gGmbH Schwäbisch Hall Not yet recruiting
Schwäbisch Hall, Baden-Württemberg, Germany, 74523
Contact: Markus Golling, Prof.       markus.golling@dasdiak.de   
Sponsors and Collaborators
Aesculap AG
B.Braun Surgical SA
Investigators
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Principal Investigator: Markus Golling, Prof. Dr. Diakonie Klinikum gGmbH Schwäbisch Hall

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Responsible Party: Aesculap AG
ClinicalTrials.gov Identifier: NCT04033211     History of Changes
Other Study ID Numbers: AAG-O-H-1816
First Posted: July 26, 2019    Key Record Dates
Last Update Posted: July 29, 2019
Last Verified: July 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Aesculap AG:
Minimal invasive surgery
Appendectomy
Cholecystectomy
Additional relevant MeSH terms:
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Appendicitis
Cholecystitis
Intraabdominal Infections
Infection
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Cecal Diseases
Intestinal Diseases
Gallbladder Diseases
Biliary Tract Diseases