'All Comer'/'Real-world' Registry-based Randomized, Prospective, Multicenter Clinical Trial to Evaluate the Incidence of Complications Using Novosyn® CHD Suture Versus Polyglactin 910 Suture to Close the Wound After Emergency or Elective Laparotomy or Laparoscopic Surgery
Status: Recruiting
Location: See all (4) locations...
Intervention Type: Device
Study Type: Observational
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.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:
• Patients undergoing an emergency or elective laparotomy or laparoscopic surgery.
• Written informed consent
• Age≥ 18 years
• Not incapacitated patient
Locations
Other Locations
Italy
Pineta Grande Hospital
RECRUITING
Napoli
Spain
Hospital Clínico San Carlos
RECRUITING
Madrid
Hospital Universitario de Canarias
RECRUITING
Santa Cruz De Tenerife
Hospital Universitario Virgen del Rocío
RECRUITING
Seville
Contact Information
Primary
Jaume Garcia Lopez
info@bbraun.com
+34935866200
Backup
Ricard Rosique
info@bbraun.com
Time Frame
Start Date:2023-09-18
Estimated Completion Date:2028-08
Participants
Target number of participants:2998
Treatments
Novosyn®
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
Polyglactin 910
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