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

Assessment of DAFILON® Suture Material in Oral Surgery (Mucosal Sutures). A Prospective, Single Arm Observational Study in Daily Practice

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

Study Overview

• Status: Completed
• Conditions: Dental Implants; Tooth Extraction; Oral Surgery
• Intervention / Treatment: Device: Mucosal Closure

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 Type: Observational
• Enrollment (Actual): 105

Contacts and Locations

Study Locations

• Germany
  • Esslingen am Neckar, Germany, 73728
    • Praxisklinik für Mund-, Kiefer- und Gesichtschirurgie, Ästhetische und Plastische Chirurgie
• Spain
  • Barcelona, Spain
    • Universitat Internacional de Catalunya (UIC)

Participation Criteria

Eligibility Criteria

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

• Sampling Method: Non-Probability Sample

Study Population

adult patients

Description

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 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
MUCODA; DAFILON - sterile, monofilament, non-absorbable surgical suture material produced from Polyamide	Device: Mucosal Closure; mucosal closure in oral surgery (mucosal sutures)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)	10 ± 5 days postoperatively (suture removal)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)	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".	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".	at suture removal 10 ± 5 days postoperative
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".	at suture removal 10 ± 5 days postoperative
knot security	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,	intraoperative
tensile strength	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,	intraoperative
knot run down	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,	intraoperative
tissue drag	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,	intraoperative
pliability	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,	intraoperative

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Bacterial contamination of the thread	optional	at suture removal 10 ± 5 days postoperative
Pain assessment using the visual analogue scale (VAS 1-100)	Optional: 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".	at follow-up up to five months postoperative
Satisfaction of the patient using the visual analogue scale (VAS 1-100)	Optional: 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".	at follow-up up to five months postoperative
Wound healing assessment using the visual analogue scale (VAS 1-100)	Optional: 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".	at follow-up up to five months postoperative
Cosmetic outcome assessed by the physician using the visual analogue scale (VAS 1-100)	Optional: This parameter will be noted by the surgeon using the Visual Analogue Scale (VAS) which state "0" at one end representing "very good cosmetic outcome" and "100" at the opposite end representing "very bad cosmetic outcome".	at follow-up up to five months postoperative

Collaborators and Investigators

• Sponsor: Aesculap AG
• Collaborators: B.Braun Surgical SA
• Investigators: Principal Investigator: Nils Weyer, Dr. med., Praxisklinik für Mund-, Kiefer- und Gesichtschirurgie Ästhetische und Plastische Chirurgie

Study record dates

Study Major Dates

• Study Start (Actual): July 6, 2020
• Primary Completion (Actual): April 7, 2021
• Study Completion (Actual): April 14, 2021

Study Registration Dates

• First Submitted: May 7, 2020
• First Submitted That Met QC Criteria: May 12, 2020
• First Posted (Actual): May 15, 2020

Study Record Updates

• Last Update Posted (Actual): December 22, 2021
• Last Update Submitted That Met QC Criteria: December 21, 2021
• Last Verified: December 1, 2021

More Information

Terms related to this study

• Keywords: complication rate; oral surgery; mucosal closure
• Other Study ID Numbers: AAG-O-H-1912

Drug and device information, study documents

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