Performance of Safety of SILKAM® Suture Material in Oral Surgery

Completed

• Conditions: Tooth, Impacted; Teeth Impact; Tooth Impaction; Mucosal Wound
• Interventions: Device: Mucosal Closure

• Registration Number: NCT05296902
• Lead Sponsor: Aesculap AG

Brief 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.

Study Timeline

• Study First Submitted: 2022-03-16
• Study First Submitted QC: 2022-03-16
• Study First Posted: 2022-03-25
• Study Start: 2022-09-21
• Primary Completion: 2023-10-21
• Study Completion: 2023-11-16
• Status Verified: 2024-02
• Last Update Submitted: 2024-02-16
• Last Update Posted: 2024-02-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 105

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).

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
SILKAM®	Mucosal Closure	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.

Primary Outcome Measures

Name	Time	Method
Surgical Wound Dehiscence rate	until day of suture removal (approximately 1 week after surgery)	Pathologic process consisting of a partial or complete disruption of the layers of a surgical wound.
Complication rate	until day of suture removal (approximately 1 week after surgery)	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).

Secondary Outcome Measures

Name	Time	Method
Satisfaction of the patient using the visual analogue scale (VAS 1-100)	until day of suture removal (approximately 1 week after surgery)	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".
Complication rate	until day of suture removal (approximately 1 week after surgery)	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.
Pain assessment using the visual analogue scale (VAS 1-100)	until day of suture removal (approximately 1 week after surgery)	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".
Wound healing assessment using the visual analogue scale (VAS 1-100)	until day of suture removal (approximately 1 week after surgery)	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".
Assessment of the handling of the suture material	intraoperatively	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.

Trial Locations

Locations (1)

Facultat D'odontologia. Universitat Internacional de Catalunya; 🇪🇸 Sant Cugat Del Vallès, Catalunya, Spain