Using Silkam® sutures for skin closure
Assessment of Performance of Silkam® Suture Material for Skin Closure - a Prospective, Single Center, Single Arm, Observational Study in Daily Practice
Aesculap AG · NCT05225714
This study tests how safe and effective Silkam® sutures are for closing skin wounds in a clinical setting.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 164 (estimated) |
| Sex | All |
| Sponsor | Aesculap AG (industry) |
| Locations | 1 site (Badalona) |
| Trial ID | NCT05225714 on ClinicalTrials.gov |
What this trial studies
This observational study evaluates the safety and performance of Silkam® suture material for skin closure in a clinical setting. It is a prospective, single-center, single-arm study that collects data on various clinical parameters related to the effectiveness of the sutures. The study aims to assess how well Silkam® performs in routine skin closure procedures, focusing on safety and effectiveness metrics.
Who should consider this trial
Good fit: Ideal candidates include adult and pediatric patients requiring skin closure with Silkam® sutures.
Not a fit: Patients with dirty wounds, those on medication affecting healing, or those allergic to the suture material may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could improve wound closure techniques and outcomes for patients undergoing skin closure procedures.
How similar studies have performed: While this study is observational, similar studies evaluating suture materials have shown promising results in improving wound closure outcomes.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Adult and paediatric patients undergoing skin closure using Silkam® as suture material. * Written informed consent regarding the data collection for the PMCF study. Exclusion Criteria: * Pregnancy * Visible dirty wounds * Patients taking medication that might affect wound healing * Patients with hypersensitivity or allergy to the suture material
Where this trial is running
Badalona
- Hospital Universitari Germans Trias i Pujol — Badalona, Spain (RECRUITING)
Study contacts
- Study coordinator: Aina L Fernández Rodríguez
- Email: info@bbraun.com
- Phone: +34 935 86 62 00
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.
Conditions: Contusions, Incision, Laceration