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

NCT ID: NCT04390620

Last Updated: 2021-12-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

105 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-07-06

Study Completion Date

2021-04-14

Brief Summary

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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

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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).

Conditions

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Oral Surgery Tooth Extraction Dental Implants

Keywords

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oral surgery mucosal closure complication rate

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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MUCODA

DAFILON - sterile, monofilament, non-absorbable surgical suture material produced from Polyamide

Mucosal Closure

Intervention Type DEVICE

mucosal closure in oral surgery (mucosal sutures)

Interventions

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Mucosal Closure

mucosal closure in oral surgery (mucosal sutures)

Intervention Type DEVICE

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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B.Braun Surgical SA

INDUSTRY

Sponsor Role collaborator

Aesculap AG

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Nils Weyer, Dr. med.

Role: PRINCIPAL_INVESTIGATOR

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

Locations

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

Esslingen am Neckar, , Germany

Site Status

Universitat Internacional de Catalunya (UIC)

Barcelona, , Spain

Site Status

Countries

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Germany Spain

Other Identifiers

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AAG-O-H-1912

Identifier Type: -

Identifier Source: org_study_id