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).
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
Enrollment
316
Experimental
Comparator
Klinikverbund Südwest Krankenhaus Leonberg Alllgemeinchirurgie
Leonberg, Baden-Wurttemberg, Germany
Diakonie Klinikum gGmbH Schwäbisch Hall
Schwäbisch Hall, Baden-Wurttemberg, Germany
Hospital Germans Trias i Pujol General and Digestive Surgery
Badalona, Spain
General Surgery Department Hospital Plató
Barcelona, Spain
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).
Time frame: until 30 days + 10 days after surgery
Development of Wound Dehiscence
Incidence of wound dehiscence (skin) at different postoperative examinations
Time frame: 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
Time frame: 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
Time frame: 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
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
Rate of suture removal due to wound problems (infection, dehiscence, residual material requiring removal) at different defined postoperative points in time
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Time frame: 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).
Time frame: until discharge (ca. 10 days postop)
Postoperative Surgical Site Infections
Incidence of postoperative surgical site infections
Time frame: 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
Time frame: 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.
Time frame: 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.
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
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)
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)
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)
Time frame: 30 days +10 day, 1 year ±2 months postoperatively
Comparison of wound appearance
Photographic documentation of the wounds for assessment
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
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
Time frame: 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"
Time frame: 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
Time frame: 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).
Time frame: 1 year ±2 months