Performance of Safety of SILKAM® Suture Material in Oral Surgery

Tooth, Impacted Clinical Trial

— SILKOS  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05296902
• Other study ID #: AAG-O-H-2038
• Status: Completed
• Start date: September 21, 2022
• Est. completion date: November 16, 2023

Study information

• Verified date: February 2024
• Source: Aesculap AG
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 105
• Est. completion date: November 16, 2023
• Est. primary completion date: October 21, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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).

Related Conditions & MeSH terms

• Tooth Impaction
• Tooth, Impacted

Intervention

Device:
• Mucosal Closure
mucosal closure in oral surgery (mucosal sutures)

Locations

Country	Name	City	State
Spain	Facultat D'odontologia. Universitat Internacional de Catalunya	Sant Cugat Del Vallès	Catalunya

Sponsors (2)

Lead Sponsor	Collaborator
Aesculap AG	B.Braun Surgical SA

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Surgical Wound Dehiscence rate	Pathologic process consisting of a partial or complete disruption of the layers of a surgical wound.	until day of suture removal (approximately 1 week after surgery)
Primary	Complication rate	Complications rate according to the "Classification of Askar" as Grade 1 (Localized complication(s) accompanied by no adverse effects on the success of the surgery) and Grade 2 (Localized complication(s) accompanied by adverse effects on the success of the surgery).	until day of suture removal (approximately 1 week after surgery)
Secondary	Complication rate	Complications rate according to the "Classification of Askar" as Grade 3 (Localized or systemic complication(s) that impairs the patient's daily routine but does not require hospitalization), Grade 4 (Localized or systemic complication(s) that impairs the patient's daily routine and requires hospitalization), Grade 5 (Localized or systemic complication(s) that inflicts irreversible damage to >1 anatomical structures), or Grade 6 (Localized or systemic complication(s) that lead to death.	until day of suture removal (approximately 1 week after surgery)
Secondary	Pain assessment using the visual analogue scale (VAS 1-100)	This parameter will be noted according to the Patient self assessment using the Visual Analogue Scale (VAS) which state "0" at one end representing "no pain" and "100" at the opposite end representing "maximal pain".	until day of suture removal (approximately 1 week after surgery)
Secondary	Satisfaction of the patient using the visual analogue scale (VAS 1-100)	This parameter will be noted according to the Patient self assessment using the Visual Analogue Scale (VAS) which state "0" at one end representing "completely satisfied" and "100" at the opposite end representing "not at all satisfied".	until day of suture removal (approximately 1 week after surgery)
Secondary	Wound healing assessment using the visual analogue scale (VAS 1-100)	This parameter will be noted by the surgeon using the Visual Analogue Scale (VAS) which state "0" at one end representing "very good wound healing" and "100" at the opposite end representing "very bad wound healing".	until day of suture removal (approximately 1 week after surgery)
Secondary	Assessment of the handling of the suture material	Evaluation of the handling of the suture material in five categories (Knot security, Knot run down, Knot pull tensile strength, Tissue drag, Pliability) with the 5 evaluation levels each: 'excellent', 'very good', 'good', 'satisfied' and 'poor' transferred into the evaluation scores 5, 4, 3, 2 and 1.	intraoperatively