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

Study acronym: POLYNOVO-CHD
StatusRecruiting
PhaseNot specified
Started
View on ClinicalTrials.gov ↗

Record History

  1. Minor Primary completion date: Jun 2028 to Aug 2028 Completion date: Aug 2028 to Dec 2028v5 Show 1 more changeShow less
    • Completion date: Aug 2028 to Dec 2028
  2. Minor Study sites: 1 to 4v4
  3. Minor Re-verified, no change to tracked fieldsv3
  4. Notable Trial status: Not Yet Recruiting to Recruiting Study sites: 0 to 1 · Start date changed from estimate of Aug 2023 to Sep 18, 2023v2 Show 2 more changesShow less
    • Study sites: 0 to 1
    • Start date changed from estimate of Aug 2023 to Sep 18, 2023
  5. Minor Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
32 trials monitored
See 6 trials at risk
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.
Trial Details
NCT Number NCT05966961
Lead Sponsor Aesculap AG
Collaborators: B.Braun Surgical SA
Conditions Surgical Site Infection
Enrollment 2,998 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov