Surgical Site Infection
Conditions
Keywords
Chlorhexidine coated suture, emergency laparoscopic surgery, emergency laparotomy surgery, elective laparoscopic surgery, elective laparotomy surgery, Novosyn®, Polyglactin 910
Brief summary
The aim of the study is to elucidate, if the colonization of bacteria is lower on the Novosyn® CHD suture compared to uncoated Polyglactin 910 suture, which will be assessed by the incidence of surgical site infections (SSI: A1 and A2). The results of this registry will generate further clinical evidence for the use and the benefit of a Chlorhexidine coated suture used to close the wound after an emergency or elective laparoscopic or laparotomy surgery. The benefit for individual patients lies in the early diagnosis of complications and in the optimized postoperative controls of a clinical study.
Interventions
DEVICENovosyn® in emergency or elective laparotomy or laparoscopic surgery
Fascia closure (and subcutaneous closure if applicable) after emergency or elective laparotomy or laparoscopic surgery.
DEVICEPolyglactin 910 in emergency or elective laparotomy or laparoscopic surgery
Fascia closure (and subcutaneous closure if applicable) after emergency or elective laparotomy or laparoscopic surgery.
Sponsors
Aesculap AG
B.Braun Surgical SA
Study design
Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Patients undergoing an emergency or elective laparotomy or laparoscopic surgery. * Written informed consent * Age≥ 18 years * Not incapacitated patient
Exclusion criteria
* No
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Frequency of surgical site infection (superficial (A1) and deep (A2) | until 30 days + 5 days after surgery. | The aim of the study is to elucidate, if the colonization of bacteria is lower on the Novosyn® CHD suture compared to uncoated Polyglactin 910 suture, which will be assessed by the incidence of surgical site infections (SSI: A1 and A2). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Handling of the suture material | intraoperatively | Assessment of the handling of the suture material intraoperatively using a questionnaire including different dimensions (knot security, tensile strength, knot run down, tissue drag etc.) with 5 evaluations levels (excellent, very good, good, satisfied, poor). |
| Length of hospital stay | until discharge (approximately 10 days after surgery) | Number of days the patient has to stay in hospital after emergency or elective laparotomy or laparoscopic surgery |
| Time to return to work | until 30 days + 5 days after surgery. | Number of days the patient needed to return to work after emergency or elective laparotomy or laparoscopic surgery |
| Incidence of Surgical Site Infection (SSI) | at discharge (approximately 10 days after surgery) | Incidence of Surgical Site Infection (SSI) (superficial (A1), deep (A2) and organ space (A3)) at the time of discharge |
| Incidence of SSI (superficial (A1), deep (A2) and organ space (A3)) stratified by wound class | until 30 days + 5 days after surgery | Incidence of SSI (superficial (A1), deep (A2) and organ space (A3)) stratified by wound class (Class I clean, Class II clean/contaminated, Class III contaminated, Class IV dirty/infected) |
| Cumulative Rate of postoperative complications | discharge (approximately 10 days after surgery) and 30 days+ 5 days after surgery. | Number of postoperative complications of any kind for descriptive analysis |
| Cumulative Rate of reoperation | at discharge (approximately 10 days after surgery) and 30 days + 5 days after surgery. | Number of reoperation of any kind for descriptive analysis |
| Cumulative Rate of suture removal due to wound problems | at discharge (approximately 10 days after surgery) and 30 days + 5 days after surgery. | Rate of suture removal due to wound problems (infection, dehiscence, residual material requiring removal) for descriptive analysis |
| Cumulative Rate of Re-suturing | at discharge (approximately 10 days after surgery) and 30 days + 5 days after surgery. | Rate of Re-suturing of any kind for descriptive analysis |
| Hernia rate | 30 days + 5 days postoperatively | Number of Wound Hernia including umbilical hernia verified by ultra-sound examination |
Countries
Italy, Spain
Contacts
CONTACTJaume Garcia Lopez
CONTACTRicard Rosique
PRINCIPAL_INVESTIGATORAntonio José Torres Garcia, Prof. Dr.
Hospital San Carlos, Madrid
Outcome results
None listed