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RECRUITING
NCT05966961

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

Sponsor: Aesculap AG

View on ClinicalTrials.gov

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.

Official title: '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

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

OBSERVATIONAL

Enrollment

2998

Start Date

2023-09-18

Completion Date

2028-12

Last Updated

2026-03-06

Healthy Volunteers

No

Interventions

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.

Locations (4)

Pineta Grande Hospital

Naples, Italy

Hospital Clínico San Carlos

Madrid, Spain

Hospital Universitario de Canarias

Santa Cruz de Tenerife, Spain

Hospital Universitario Virgen del Rocío

Seville, Spain