Assessment of DAFILON® Suture Material in Oral Surgery (Mucosal Sutures)

Aesculap AG105 enrolled

Overview

In this non-interventional study (NIS) a polyamide non-absorbable suture (Dafilon) will be evaluated for oral surgery (mucosal closure after e.g. wisdom teeth extraction, implant surgery, etc.) in adult patients. The aim of this NIS is to collect systematically and proactively different clinical parameters regarding safety, effectiveness and performance of Dafilon 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 10 ± 5 days post-operatively (and post-operatively depending on routine clinical practice of each hospital).

Study Type

OBSERVATIONAL

Enrollment

105

Conditions

Oral Surgery Tooth Extraction Dental Implants

Interventions

Mucosal ClosureDEVICE

mucosal closure in oral surgery (mucosal sutures)

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Adult patients undergoing mucosal wound closure using Dafilon 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 included). * Written informed consent regarding the data collection for the PMCF. Exclusion Criteria: * Emergency surgery. * Oral surgery procedures requiring bone regeneration. * Pregnancy. * Patients taking medication that might affect wound healing. * Patients with hypersensitivity or allergy to the suture material.

Locations (2)

Praxisklinik für Mund-, Kiefer- und Gesichtschirurgie, Ästhetische und Plastische Chirurgie

Esslingen am Neckar, Germany

Universitat Internacional de Catalunya (UIC)

Barcelona, Spain

Outcomes

Primary Outcomes

incidence of combined postoperative complications Grade I and Grade II

combined incidence of postoperative complications Grade I \& II on a Five Point scale defined by Askar et al. (Grade I: postoperative dentinal hypersensitivity / Oral candidiasis / Angular cheilitis / Exaggerated swelling defined as postoperative enlargement of tissues that exceeds the normal limits associated with a given surgical procedure / Delayed wound healing defined as an unusual deviation from the normal course of healing / Mild postoperative bleeding defined as the presence of small amount of blood in the oral cavity, usually mixed with saliva; Grade II: Flap dehiscence / Membrane exposure / Localized infection of the surgical site / Graft necrosis)

Time frame: 10 ± 5 days postoperatively (suture removal)

Secondary Outcomes

Incidence of individual postoperative complications

incidence of postoperative complications of Grade I - V on a Five Point scale defined by Askar et al. (Grade I \& II see Primary Outcome; Grade III: Fever / Skin rash / Neuropraxia/paresthesia / Trimus / Osteomyelitis / Septicemia / Sinusitis / Alveolar osteitis / Chymosis / Excessive and severe bleeding / Prolonged exaggerated swelling; Grade IV: Major complications that required immediate hospitalization such as drug induced anaphylaxis or septicemia; Grade V: Major complications that led to irreversible damage such neurotmesis and axonotmesis)

Time frame: until suture removal 10 ± 5 days postoperative

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: at suture removal 10 ± 5 days postoperative

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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