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

NCT04390620 | Completed

• 1 other identifier: AAG-O-H-1912
• Study Type: observational
• Target: 105
• Locations: 2 countries
• Sites: 2

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

Conditions

Oral Surgery; Tooth Extraction; Dental Implants

Keywords

oral surgery; mucosal closure; complication rate

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (9)

• Incidence of individual postoperative complications

  until suture removal 10 ± 5 days postoperative

• Pain assessment using the visual analogue scale (VAS 1-100)

  at suture removal 10 ± 5 days postoperative

• Satisfaction of the patient using the visual analogue scale (VAS 1-100)

  at suture removal 10 ± 5 days postoperative

• Wound healing assessment using the visual analogue scale (VAS 1-100)

  at suture removal 10 ± 5 days postoperative

• knot security

  intraoperative

Other Outcomes (5)

• Bacterial contamination of the thread

  at suture removal 10 ± 5 days postoperative

• Pain assessment using the visual analogue scale (VAS 1-100)

  at follow-up up to five months postoperative

• Satisfaction of the patient using the visual analogue scale (VAS 1-100)

  at follow-up up to five months postoperative

Study Arms (1)

MUCODA

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

Device: Mucosal Closure

Interventions

Mucosal Closure DEVICE

mucosal closure in oral surgery (mucosal sutures)

MUCODA

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

adult patients

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Aesculap AG: lead
• B.Braun Surgical SA: collaborator

Study Sites (2)

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

Esslingen am Neckar, 73728, Germany

Location

Universitat Internacional de Catalunya (UIC)

Barcelona, Spain

Location

Study Officials

• Nils Weyer, Dr. med.

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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 7, 2020
• First Posted: May 15, 2020
• Study Start: July 6, 2020
• Primary Completion: April 7, 2021
• Study Completion: April 14, 2021
• Last Updated: December 22, 2021

Record last verified: 2021-12

Locations

ES (1); DE (1)