Novosyn® CHD vs Polyglactin 910 Suture to Close Wounds After Emergency or Elective Laparotomy or Laparoscopic Surgery (POLYNOVO-CHD)

Aesculap

Status: Enrolling

Conditions: Surgical Site Infection

Treatments: Device: Polyglactin 910 in emergency or elective laparotomy or laparoscopic surgery; Device: Novosyn® in emergency or elective laparotomy or laparoscopic surgery

Study type: Observational

Funder types: Industry

Identifiers

NCT05966961

AAG-G-H-2201

Details and patient eligibility

About

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.

Enrollment: 2,998 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patients undergoing an emergency or elective laparotomy or laparoscopic surgery.
• Written informed consent
• Age≥ 18 years
• Not incapacitated patient

Exclusion criteria

• No exclusion criteria except patients with allergy or hypersensitivity to chlorhexidine

Trial design

2,998 participants in 2 patient groups

Novosyn®

Description:

Sutures will be used to close the laparotomy or trocar incision in emergency or elective surgery. The suture material will be applied for fascia closure (and subcutaneous closure if applicable) in the context of daily clinical routine

Treatment:

Device: Novosyn® in emergency or elective laparotomy or laparoscopic surgery

Polyglactin 910

Description:

Sutures will be used to close the laparotomy or trocar incision in emergency or elective surgery. The suture material will be applied for fascia closure (and subcutaneous closure if applicable) in the context of daily clinical routine

Treatment:

Device: Polyglactin 910 in emergency or elective laparotomy or laparoscopic surgery