Comparing two types of sutures for closing surgical wounds
'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
This study is testing whether a special coated suture can help prevent infections better than a regular suture in patients having surgery.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 2998 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Aesculap AG Industry-sponsored |
| Locations | 4 sites (Naples and 3 other locations) |
| Trial ID | NCT05966961 on ClinicalTrials.gov |
What this trial studies
This study aims to compare the effectiveness of Novosyn® CHD, a Chlorhexidine coated suture, against uncoated Polyglactin 910 suture in reducing bacterial colonization and the incidence of surgical site infections (SSI) in patients undergoing emergency or elective laparotomy or laparoscopic surgery. By observing the outcomes of these two sutures, the study seeks to provide clinical evidence on the benefits of using a coated suture for wound closure. The findings will help optimize postoperative care and early diagnosis of complications.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older undergoing emergency or elective laparotomy or laparoscopic surgery.
Not a fit: Patients with allergies or hypersensitivity to chlorhexidine may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to reduced rates of surgical site infections, improving patient recovery and outcomes.
How similar studies have performed: Other studies have shown promising results with Chlorhexidine coated sutures, indicating potential benefits in reducing infection rates.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Naples and 3 other locations
- Pineta Grande Hospital — Naples, Italy (Recruiting)
- Hospital Clínico San Carlos — Madrid, Spain (Recruiting)
- Hospital Universitario de Canarias — Santa Cruz de Tenerife, Spain (Recruiting)
- Hospital Universitario Virgen del Rocío — Seville, Spain (Recruiting)
Study contacts
- Principal investigator: Antonio José Torres Garcia, Prof. Dr. — Hospital San Carlos, Madrid
- Study coordinator: Jaume Garcia Lopez
- Email: info@bbraun.com
- Phone: +34935866200
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.