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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
Aesculap AG·ClinicalTrials.gov·device·Device trialNot yet recruiting
View on ClinicalTrials.gov →
Study focus
Disease/Condition
Surgical Site Infection
Drug/Device/Intervention
Novosyn® in emergency or elective laparotomy or laparoscopic surgery
Study type
Observational
Intervention type
device
Sponsor & location
Primary sponsor
Aesculap AG
Timeline & enrollment
Phase
N/A
Start date
Aug 01, 2023
End date
Aug 01, 2028
Enrollment
2998 participants
Primary outcome

Frequency of surgical site infection (superficial (A1) and deep (A2)

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.

ICD-10 classifications
Infection following a procedure, not elsewhere classifiedBacterial infection of unspecified siteOther bacterial infections of unspecified siteInfection of obstetric surgical woundOther specified local infections of skin and subcutaneous tissue
Data source
Registry
ClinicalTrials.gov
Trial ID
NCT05966961
Type
Device Trial
About this record

Access comprehensive clinical trial information for NCT05966961 through Pure Global AI's free database. This phase not specified trial is sponsored by Aesculap AG and is currently Not yet recruiting. The study focuses on Surgical Site Infection. Target enrollment is 2998 participants.

This page provides complete trial specifications, intervention details, outcomes, and location information. Pure Global AI offers free access to ClinicalTrials.gov data, helping medical device and pharmaceutical companies navigate clinical research efficiently.