Performance of Safety of SILKAM® Suture Material in Oral Surgery

Aesculap AG105 enrolled

Overview

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

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

105

Conditions

Tooth, Impacted Teeth Impact Tooth Impaction Mucosal Wound

Interventions

Mucosal ClosureDEVICE

mucosal closure in oral surgery (mucosal sutures)

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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).

Locations (1)

Facultat D'odontologia. Universitat Internacional de Catalunya

Sant Cugat del Vallès, Catalonia, Spain

Outcomes

Primary Outcomes

Surgical Wound Dehiscence rate

Pathologic process consisting of a partial or complete disruption of the layers of a surgical wound.

Time frame: 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).

Time frame: until day of suture removal (approximately 1 week after surgery)

Secondary Outcomes

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.

Time frame: 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".

Time frame: 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".

Data from ClinicalTrials.gov

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