Clinical trial NCT04390620: Assessment of DAFILON® Suture Material in Oral Surgery (Mucosal Sutures)
Official title: Assessment of DAFILON® Suture Material in Oral Surgery (Mucosal Sutures). A Prospective, Single Arm Observational Study in Daily Practice
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Oral Surgery
Tooth Extraction
Dental Implants
Keywords: oral surgery
mucosal closure
complication rate
Lead sponsor: Aesculap AG
Sponsor class: INDUSTRY
Collaborators: name: B.Braun Surgical SA
First posted: 2020-05-15
Enrollment: 105
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: adult patients

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).

Eligibility criteria: 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.

Primary outcomes:
measure: incidence of combined postoperative complications Grade I and Grade II
timeFrame: 10 ± 5 days postoperatively (suture removal)
Secondary outcomes:
measure: Incidence of individual postoperative complications
timeFrame: until suture removal 10 ± 5 days postoperative
measure: Pain assessment using the visual analogue scale (VAS 1-100)
timeFrame: at suture removal 10 ± 5 days postoperative
measure: Satisfaction of the patient using the visual analogue scale (VAS 1-100)
timeFrame: at suture removal 10 ± 5 days postoperative
measure: Wound healing assessment using the visual analogue scale (VAS 1-100)
timeFrame: at suture removal 10 ± 5 days postoperative
measure: knot security
timeFrame: intraoperative
measure: tensile strength
timeFrame: intraoperative
measure: knot run down
timeFrame: intraoperative
measure: tissue drag
timeFrame: intraoperative
measure: pliability
timeFrame: intraoperative
Other outcomes:
measure: Bacterial contamination of the thread
timeFrame: at suture removal 10 ± 5 days postoperative
measure: Pain assessment using the visual analogue scale (VAS 1-100)
timeFrame: at follow-up up to five months postoperative
measure: Satisfaction of the patient using the visual analogue scale (VAS 1-100)
timeFrame: at follow-up up to five months postoperative
measure: Wound healing assessment using the visual analogue scale (VAS 1-100)
timeFrame: at follow-up up to five months postoperative
measure: Cosmetic outcome assessed by the physician using the visual analogue scale (VAS 1-100)
timeFrame: at follow-up up to five months postoperative
Locations:
city: Esslingen am Neckar
country: Germany
facility: Praxisklinik für Mund-, Kiefer- und Gesichtschirurgie, Ästhetische und Plastische Chirurgie
city: Barcelona
country: Spain
facility: Universitat Internacional de Catalunya (UIC)
Study officials:
affiliation: Praxisklinik für Mund-, Kiefer- und Gesichtschirurgie Ästhetische und Plastische Chirurgie
name: Nils Weyer, Dr. med.
role: PRINCIPAL_INVESTIGATOR
References: