NOVOsyn® for Trocar Incision After Laparoscopic Appendectomy and Cholecystectomy
- Conditions
- AppendicitisCholecystitis
- Interventions
- Device: Novosyn® CHD for fascia and skin closureDevice: Novosyn® for fascia and skin closure
- Registration Number
- NCT04033211
- Lead Sponsor
- 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).
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 316
- Patients undergoing a primary emergency or early elective (24h - 7 days) laparoscopic appendectomy or cholecystectomy.
- Written informed consent
- Age≥ 18 years
- Not incapacitated patient
- 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
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Novosyn® CHD Novosyn® CHD for fascia and skin closure 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® Novosyn® for fascia and skin closure 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.
- Primary Outcome Measures
Name Time Method Surgical Site Infection 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
Name Time Method Development of Wound Dehiscence 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
Hernia Rate / Umbilical Hernia Rate 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
Mortality Rate until discharge (ca. 10 days postop), 30 days +10 days, and 1 year ±2 months postoperatively Incidence of mortality rate at different postoperative times
Suture Removal due to Wound Problems during the postoperative Course 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
Time to return to work 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.
Postoperative Complications during the postoperative Course 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
Rate of Conversion to open surgery intraoperatively Number of interventions where operation technique has to be converted to open surgery intraoperatively
Comparison of wound appearance discharge (ca. 10 days postop), 30 days +10 days and 1 year ±2 months postoperatively Photographic documentation of the wounds for assessment
Reoperation Rate until discharge (ca. 10 days postop), 30 days +10 days and 1 year ±2 months postoperatively Incidence of reoperation rate at different postoperative times
Postoperative Surgical Site Infections 1 year ±2 months post-op Incidence of postoperative surgical site infections
Course of Overall patient and observer satisfaction with the scar: Patient and Observer Scar Assessment Scale (POSAS) 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 handling parameters of the suture materials 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
Length of hospital stay until discharge (ca. 10 days postop) Defined as the time period from day of operation until day of discharge (efficacy parameter).
Course of Pain: Visual Analogue Scale (VAS) 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 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 Health Status 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"
Costs (economics) 1 year ±2 months Assessment of costs will be calculated on postoperative complication (SSI) in both suture groups (efficient parameter).
Trial Locations
- Locations (4)
Klinikverbund Südwest Krankenhaus Leonberg Alllgemeinchirurgie
🇩🇪Leonberg, Baden-Württemberg, Germany
Diakonie Klinikum gGmbH Schwäbisch Hall
🇩🇪Schwäbisch Hall, Baden-Württemberg, Germany
Hospital Germans Trias i Pujol General and Digestive Surgery
🇪🇸Badalona, Spain
General Surgery Department Hospital Plató
🇪🇸Barcelona, Spain