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Novosyn® CHD vs Polyglactin 910 Suture to Close Wounds After Emergency or Elective Laparotomy or Laparoscopic Surgery - Trial NCT05966961

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.

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Trial Details
ClinicalTrials.govNCT05966961
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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

Study Focus

Surgical Site Infection

Novosyn® in emergency or elective laparotomy or laparoscopic surgery

Observational

device

Sponsor & Location

Aesculap AG

Timeline & Enrollment

N/A

Aug 01, 2023

Aug 01, 2028

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 classified
Bacterial infection of unspecified site
Other bacterial infections of unspecified site
Infection of obstetric surgical wound
Other specified local infections of skin and subcutaneous tissue

Data Source

ClinicalTrials.gov

NCT05966961

Device Trial