Assessment of DAFILON® Suture Material in Oral Surgery (Mucosal Sutures) (MUCODA)
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About
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
Full 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).
Enrollment
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Volunteers
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.
Trial design
105 participants in 1 patient group
Trial contacts and locations
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Data sourced from clinicaltrials.gov
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