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Recruiting NCT05966961

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

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Trial Parameters

Condition Surgical Site Infection
Sponsor Aesculap AG
Study Type OBSERVATIONAL
Phase N/A
Enrollment 2,998
Sex ALL
Min Age 18 Years
Max Age N/A
Start Date 2023-09-18
Completion 2028-08
Interventions
Novosyn® in emergency or elective laparotomy or laparoscopic surgeryPolyglactin 910 in emergency or elective laparotomy or laparoscopic surgery

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Brief 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 Criteria

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

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