NOVOsyn® for Trocar Incision After Laparoscopic Appendectomy and Cholecystectomy

Study Overview
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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).

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.

Official Title
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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

Conditions
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Appendicitis, Cholecystitis

Intervention / Treatment
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* Device: Novosyn® CHD for fascia and skin closure
* Device: Novosyn® for fascia and skin closure


Participation Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Novosyn® CHD<br>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<br>* Experimental<br>|
| Novosyn®<br>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<br>* Comparator<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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). | until 30 days + 10 days after surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Development of Wound Dehiscence | Incidence of wound dehiscence (skin) at different postoperative examinations | 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 | 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 | 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 | 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 | 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). | until discharge (ca. 10 days postop) | 
| Postoperative Surgical Site Infections | Incidence of postoperative surgical site infections | 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 | 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. | 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. | 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) | 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) | 30 days +10 day, 1 year ±2 months postoperatively | 
| Comparison of wound appearance | Photographic documentation of the wounds for assessment | 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 | 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 | 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 | 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). | 1 year ±2 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Minimal invasive surgery, Appendectomy, Cholecystectomy