Appendicitis, Cholecystitis
Conditions
Keywords
Minimal invasive surgery, Appendectomy, Cholecystectomy
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.
Interventions
DEVICENovosyn® CHD for fascia and skin closure
Experimental
DEVICENovosyn® for fascia and skin closure
Comparator
Sponsors
B.Braun Surgical SA
Aesculap AG
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| 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 |
| 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 |
| 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 |
| 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). |
| Postoperative Surgical Site Infections | 1 year ±2 months post-op | Incidence of postoperative surgical site infections |
| Rate of Conversion to open surgery | intraoperatively | Number of interventions where operation technique has to be converted to open surgery intraoperatively |
| 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. |
| 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 |
| 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 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 wound appearance | 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 | 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 | 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 | 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) | 1 year ±2 months | Assessment of costs will be calculated on postoperative complication (SSI) in both suture groups (efficient 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. |
Countries
Germany, Spain
Outcome results
None listed