NCT05966961 Novosyn® CHD vs Polyglactin 910 Suture to Close Wounds After Emergency or Elective Laparotomy or Laparoscopic Surgery
| NCT ID | NCT05966961 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Aesculap AG |
| Condition | Surgical Site Infection |
| Study Type | OBSERVATIONAL |
| Enrollment | 2,998 participants |
| Start Date | 2023-09-18 |
| Primary Completion | 2028-08 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 2,998 participants in total. It began in 2023-09-18 with a primary completion date of 2028-08.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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
Contact & Investigator
Antonio José Torres Garcia, Prof. Dr.
PRINCIPAL INVESTIGATOR
Hospital San Carlos, Madrid
Frequently Asked Questions
Who can join the NCT05966961 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Surgical Site Infection. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05966961 currently recruiting?
Yes, NCT05966961 is actively recruiting participants. Contact the research team at info@bbraun.com for enrollment information.
Where is the NCT05966961 trial being conducted?
This trial is being conducted at Naples, Italy, Madrid, Spain, Santa Cruz de Tenerife, Spain, Seville, Spain.
Who is sponsoring the NCT05966961 clinical trial?
NCT05966961 is sponsored by Aesculap AG. The principal investigator is Antonio José Torres Garcia, Prof. Dr. at Hospital San Carlos, Madrid. The trial plans to enroll 2,998 participants.