Performance of Safety of SILKAM® Suture Material in Oral Surgery

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

Detailed Description
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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.

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

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

Intervention / Treatment
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* Device: Mucosal Closure


Participation Criteria
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Eligibility Criteria
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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).

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| SILKAM®<br>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. | Device: Mucosal Closure<br>* mucosal closure in oral surgery (mucosal sutures)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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) | 
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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) | 
| 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) | 
| 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) | 
| 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) | 
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Tooth distraction, Removal of impacted Teeth, Oral Surgery, Dental Implant, Observational Study