NCT05966961

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

'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
• Phase: —
• Study type: Observational
• Enrollment: 2,998 (estimated)
• Sponsor: Aesculap AG · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Surgical Site Infection

Interventions

Type	Name	Description
DEVICE	Novosyn® in emergency or elective laparotomy or laparoscopic surgery	Fascia closure (and subcutaneous closure if applicable) after emergency or elective laparotomy or laparoscopic surgery.
DEVICE	Polyglactin 910 in emergency or elective laparotomy or laparoscopic surgery	Fascia closure (and subcutaneous closure if applicable) after emergency or elective laparotomy or laparoscopic surgery.

Timeline

• Start date: 2023-09-18
• Primary completion: 2028-08-01
• Completion: 2028-12-01
• First posted: 2023-08-01
• Last updated: 2026-03-06

Locations

4 sites across 2 countries: Italy, Spain