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

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

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

Study Overview

• Status: Completed
• Conditions: Tooth, Impacted; Tooth Impaction; Teeth Impact; Mucosal Wound
• Intervention / Treatment: Device: Mucosal Closure

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 Type: Observational
• Enrollment (Actual): 105

Contacts and Locations

Study Locations

• Spain
  • Catalunya
    • Sant Cugat Del Vallès, Catalunya, Spain, 08195
      • Facultat d'Odontologia. Universitat Internacional de Catalunya

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Adult patients undergoing mucosal closure in oral surgery (mucosal sutures).

Description

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 Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
SILKAM®; 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; mucosal closure in oral surgery (mucosal sutures)

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Aesculap AG
• Collaborators: B.Braun Surgical SA
• Investigators: Principal Investigator: Marc Quevedo Pou, Dr., Facultat d'Odontologia. Universitat Internacional de Catalunya

Study record dates

Study Major Dates

• Study Start (Actual): September 21, 2022
• Primary Completion (Actual): October 21, 2023
• Study Completion (Actual): November 16, 2023

Study Registration Dates

• First Submitted: March 16, 2022
• First Submitted That Met QC Criteria: March 16, 2022
• First Posted (Actual): March 25, 2022

Study Record Updates

• Last Update Posted (Actual): February 20, 2024
• Last Update Submitted That Met QC Criteria: February 16, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Keywords: Observational Study; Dental Implant; Oral Surgery; Tooth distraction; Removal of impacted Teeth
• Additional Relevant MeSH Terms: Stomatognathic Diseases; Tooth Diseases; Tooth, Impacted
• Other Study ID Numbers: AAG-O-H-2038

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No