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.
Study Type
OBSERVATIONAL
Enrollment
2,998
Fascia closure (and subcutaneous closure if applicable) after emergency or elective laparotomy or laparoscopic surgery.
Fascia closure (and subcutaneous closure if applicable) after emergency or elective laparotomy or laparoscopic surgery.
Pineta Grande Hospital
Napoli, Italy
RECRUITINGHospital Clínico San Carlos
Madrid, Spain
RECRUITINGHospital Universitario de Canarias
Santa Cruz de Tenerife, Spain
RECRUITINGHospital Universitario Virgen del Rocío
Seville, Spain
RECRUITINGFrequency of surgical site infection (superficial (A1) and deep (A2)
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).
Time frame: until 30 days + 5 days after surgery.
Handling of the suture material
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).
Time frame: intraoperatively
Length of hospital stay
Number of days the patient has to stay in hospital after emergency or elective laparotomy or laparoscopic surgery
Time frame: until discharge (approximately 10 days after surgery)
Time to return to work
Number of days the patient needed to return to work after emergency or elective laparotomy or laparoscopic surgery
Time frame: until 30 days + 5 days after surgery.
Incidence of Surgical Site Infection (SSI)
Incidence of Surgical Site Infection (SSI) (superficial (A1), deep (A2) and organ space (A3)) at the time of discharge
Time frame: at discharge (approximately 10 days after surgery)
Incidence of SSI (superficial (A1), deep (A2) and organ space (A3)) stratified by wound class
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)
Time frame: until 30 days + 5 days after surgery
Cumulative Rate of postoperative complications
Number of postoperative complications of any kind for descriptive analysis
Time frame: discharge (approximately 10 days after surgery) and 30 days+ 5 days after surgery.
Cumulative Rate of reoperation
Number of reoperation of any kind for descriptive analysis
Time frame: at discharge (approximately 10 days after surgery) and 30 days + 5 days after surgery.
Cumulative Rate of suture removal due to wound problems
Rate of suture removal due to wound problems (infection, dehiscence, residual material requiring removal) for descriptive analysis
Time frame: at discharge (approximately 10 days after surgery) and 30 days + 5 days after surgery.
Cumulative Rate of Re-suturing
Rate of Re-suturing of any kind for descriptive analysis
Time frame: at discharge (approximately 10 days after surgery) and 30 days + 5 days after surgery.
Hernia rate
Number of Wound Hernia including umbilical hernia verified by ultra-sound examination
Time frame: 30 days + 5 days postoperatively
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