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

Last updated: January 31, 2025
Sponsor: Aesculap AG
Overall Status: Active - Recruiting

Phase

N/A

Condition

N/A

Treatment

Polyglactin 910 in emergency or elective laparotomy or laparoscopic surgery

Novosyn® in emergency or elective laparotomy or laparoscopic surgery

Clinical Study ID

NCT05966961
AAG-G-H-2201
  • Ages > 18
  • All Genders

Study 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

Inclusion Criteria:

  • Patients undergoing an emergency or elective laparotomy or laparoscopic surgery.

  • Written informed consent

  • Age≥ 18 years

  • Not incapacitated patient

Exclusion

Exclusion Criteria:

  • No exclusion criteria except patients with allergy or hypersensitivity tochlorhexidine

Study Design

Total Participants: 2998
Treatment Group(s): 2
Primary Treatment: Polyglactin 910 in emergency or elective laparotomy or laparoscopic surgery
Phase:
Study Start date:
September 18, 2023
Estimated Completion Date:
August 31, 2028

Connect with a study center

  • Pineta Grande Hospital

    Napoli,
    Italy

    Active - Recruiting

  • Hospital Clínico San Carlos

    Madrid,
    Spain

    Active - Recruiting

  • Hospital Universitario Virgen del Rocío

    Sevilla,
    Spain

    Active - Recruiting

  • Hospital Universitario de Canarias

    Sta. Cruz de Tenerife,
    Spain

    Active - Recruiting

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