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

Completed

• Conditions: Oral Surgery; Tooth Extraction; Dental Implants
• Interventions: Device: Mucosal Closure

• Registration Number: NCT04390620
• Lead Sponsor: Aesculap AG

Brief Summary

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

Detailed Description

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 Timeline

• Study First Submitted: 2020-05-07
• Study First Submitted QC: 2020-05-12
• Study First Posted: 2020-05-15
• Study Start: 2020-07-06
• Primary Completion: 2021-04-07
• Study Completion: 2021-04-14
• Status Verified: 2021-12
• Last Update Submitted: 2021-12-21
• Last Update Posted: 2021-12-22

Recruitment & Eligibility

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

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
MUCODA	Mucosal Closure	DAFILON - sterile, monofilament, non-absorbable surgical suture material produced from Polyamide

Primary Outcome Measures

Name	Time	Method
incidence of combined postoperative complications Grade I and Grade II	10 ± 5 days postoperatively (suture removal)	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)

Secondary Outcome Measures

Name	Time	Method
Wound healing assessment using the visual analogue scale (VAS 1-100)	at suture removal 10 ± 5 days postoperative	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".
Incidence of individual postoperative complications	until suture removal 10 ± 5 days postoperative	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)
pliability	intraoperative	Evaluation of pliability with the 5 evaluation levels 'excellent', 'very good', 'good', 'satisfied' and 'poor' into the evaluation scores 5, 4, 3, 2 and 1,
Satisfaction of the patient using the visual analogue scale (VAS 1-100)	at suture removal 10 ± 5 days postoperative	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".
tensile strength	intraoperative	Evaluation of tensile strength with the 5 evaluation levels 'excellent', 'very good', 'good', 'satisfied' and 'poor' into the evaluation scores 5, 4, 3, 2 and 1,
knot run down	intraoperative	Evaluation of knot run down with the 5 evaluation levels 'excellent', 'very good', 'good', 'satisfied' and 'poor' into the evaluation scores 5, 4, 3, 2 and 1,
knot security	intraoperative	Evaluation of Knot security with the 5 evaluation levels 'excellent', 'very good', 'good', 'satisfied' and 'poor' into the evaluation scores 5, 4, 3, 2 and 1,
Pain assessment using the visual analogue scale (VAS 1-100)	at suture removal 10 ± 5 days postoperative	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".
tissue drag	intraoperative	Evaluation of tissue drag with the 5 evaluation levels 'excellent', 'very good', 'good', 'satisfied' and 'poor' into the evaluation scores 5, 4, 3, 2 and 1,

Trial Locations

Locations (2)

Universitat Internacional de Catalunya (UIC); 🇪🇸 Barcelona, Spain

Praxisklinik für Mund-, Kiefer- und Gesichtschirurgie, Ästhetische und Plastische Chirurgie; 🇩🇪 Esslingen am Neckar, Germany