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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 : October 18, 2019
Sponsor:
Collaborator:
B.Braun Surgical SA
Information provided by (Responsible Party):
Aesculap AG

Tracking Information
First Submitted Date July 4, 2019
First Posted Date July 26, 2019
Last Update Posted Date October 18, 2019
Estimated Study Start Date November 2019
Estimated Primary Completion Date October 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: July 25, 2019)
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).
Original Primary Outcome Measures Same as current
Change History Complete list of historical versions of study NCT04033211 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures
 (submitted: July 26, 2019)
  • 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
  • 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
  • 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
  • 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
  • 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
  • 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).
  • Postoperative Surgical Site Infections [ Time Frame: 1 year ±2 months post-op ]
    Incidence of postoperative surgical site infections
  • Rate of Conversion to open surgery [ Time Frame: intraoperatively ]
    Number of interventions where operation technique has to be converted to open surgery intraoperatively
  • 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.
  • 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.
  • 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)
  • 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)
  • 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
  • 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
  • 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"
  • 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
  • Costs (economics) [ Time Frame: 1 year ±2 months ]
    Assessment of costs will be calculated on postoperative complication (SSI) in both suture groups (efficient parameter).
Original Secondary Outcome Measures
 (submitted: July 25, 2019)
  • 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
  • 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
  • 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
  • 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
  • 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
  • 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).
  • Postoperative Surgical Site Infections [ Time Frame: 1 year ±2 months post-op ]
    Incidence of postoperative surgical site infections
  • Conversion of operative technique [ Time Frame: intraoperatively ]
    Conversion to open surgery intraoperatively
  • 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.
  • 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.
  • Course of Cosmetic result [ Time Frame: 30 days +10 days, 1 year ±2 months postoperatively ]
    Cosmetic result after surgery 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 using the patient component of the Patient and Observer Scar Assessment Scale (POSAS). The physician will use the Observer component of the POSAS to assess the cosmetic outcome.
  • 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 using the patient component of the Patient and Observer Scar Assessment Scale (POSAS). The physician will use the Observer component of the POSAS to assess the cosmetic outcome.
  • 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
  • Handling [ Time Frame: intraoperatively ]
    Assessment of the suture material will be performed intra-operatively using a questionnaire including different dimensions (ease of passage through the tissue, first throw knot holding, knot security, knot tie down smoothness, surgical hand, memory effect and degree of fraying) with 5 point scale (excellent, very good, good, satisfied, poor) and the overall handling of the suture material
  • 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"
  • 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
  • Costs (economics) [ Time Frame: 1 year ±2 months ]
    Assessment of costs will be calculated on postoperative complication (SSI) in both suture groups (efficient parameter).
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title NOVOsyn® for Trocar Incision After Laparoscopic Appendectomy and Cholecystectomy
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
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).
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
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
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.
Condition
  • Appendicitis
  • Cholecystitis
Intervention
  • Device: Novosyn® CHD for fascia and skin closure
    Experimental
  • Device: Novosyn® for fascia and skin closure
    Comparator
Study Groups/Cohorts
  • 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.
    Intervention: 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.
    Intervention: Device: Novosyn® for fascia and skin closure
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Not yet recruiting
Estimated Enrollment
 (submitted: July 25, 2019)
282
Original Estimated Enrollment Same as current
Estimated Study Completion Date December 2021
Estimated Primary Completion Date October 2020   (Final data collection date for primary outcome measure)
Eligibility 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
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts
Contact: Petra Baumann, Dr. +49-7461-95-0 ext 1646 petra.baumann@aesculap.de
Listed Location Countries Germany,   Spain
Removed Location Countries  
 
Administrative Information
NCT Number NCT04033211
Other Study ID Numbers AAG-O-H-1816
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement
Plan to Share IPD: No
Responsible Party Aesculap AG
Study Sponsor Aesculap AG
Collaborators B.Braun Surgical SA
Investigators
Principal Investigator: Markus Golling, Prof. Dr. Diakonie Klinikum gGmbH Schwäbisch Hall
PRS Account Aesculap AG
Verification Date October 2019