Clinical Trials Directory

Trials / Completed

CompletedNCT05296902

Performance of Safety of SILKAM® Suture Material in Oral Surgery

Single Center Open-Label Post Market Clinical Follow-Up (PMCF) -Study on the Performance of Safety of SILKAM® Suture Material in Oral Surgery

Status
Completed
Phase
Study type
Observational
Enrollment
105 (actual)
Sponsor
Aesculap AG · Industry
Sex
All
Age
18 Years
Healthy volunteers
Not accepted

Summary

Assessment of SILKAM® suture material in mucosal closure in oral surgery (mucosal sutures). A prospective, monocentric, single arm observational study.

Detailed description

The aim of this Non Interventional Study is to collect systematically and proactively different clinical parameters regarding safety, effectiveness, and performance of SILKAM® suture material under the daily routine clinical practice when is intended to be used for oral surgery. All patients enrolled will be prospectively followed until suture removal, which takes place approximately one week post-operatively.

Conditions

Interventions

TypeNameDescription
DEVICEMucosal Closuremucosal closure in oral surgery (mucosal sutures)

Timeline

Start date
2022-09-21
Primary completion
2023-10-21
Completion
2023-11-16
First posted
2022-03-25
Last updated
2024-02-20

Locations

1 site across 1 country: Spain

Source: ClinicalTrials.gov record NCT05296902. Inclusion in this directory is not an endorsement.