Performance of Safety of SILKAM® Suture Material in Oral Surgery (SILKOS)

Aesculap

Status: Completed

Conditions: Tooth, Impacted; Teeth Impact; Tooth Impaction; Mucosal Wound

Treatments: Device: Mucosal Closure

Study type: Observational

Funder types: Industry

Identifiers

NCT05296902

AAG-O-H-2038

Details and patient eligibility

About

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

Full 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.

Enrollment: 105 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patients undergoing mucosal wound closure using SILKAM® as suture material in oral surgery (in the event that more than one incision is performed in the same patient, only one incision will be considered).

Exclusion criteria

• Patients taking medication that might affect wound healing
• Patients having a condition that might affect wound healing.
• Patients with hypersensitivity or allergy to the suture material.
• Participation in another (Randomized) Clinical Trial / Clinical Study.
• Non-compliance of patient (i.e. dementia).

Trial design

105 participants in 1 patient group

SILKAM®

Description:

SILKAM® is a non-absorbable sterile suture material made from braided silk fibrils. It is available either undyed (white) or dyed black with hematein and is coated with refined paraffin wax or beeswax.

Treatment:

Device: Mucosal Closure