Clinical trial NCT05296902: Performance of Safety of SILKAM® Suture Material in Oral Surgery
Official title: Single Center Open-Label Post Market Clinical Follow-Up (PMCF) -Study on the Performance of Safety of SILKAM® Suture Material in Oral Surgery
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Tooth, Impacted
Teeth Impact
Tooth Impaction
Mucosal Wound
Keywords: Tooth distraction
Removal of impacted Teeth
Oral Surgery
Dental Implant
Observational Study
Lead sponsor: Aesculap AG
Sponsor class: INDUSTRY
Collaborators: name: B.Braun Surgical SA
First posted: 2022-03-25
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 undergoing mucosal closure in oral surgery (mucosal sutures).

Brief summary: Assessment of SILKAM® suture material in mucosal closure in oral surgery (mucosal sutures). A prospective, monocentric, single arm observational study.

Detailed description: The aim of this Non Interventional Study is to collect systematically and proactively different clinical parameters regarding safety, effectiveness, and performance of SILKAM® 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 approximately one week post-operatively.

Eligibility criteria: Inclusion Criteria:

* Patients undergoing mucosal wound closure using SILKAM® 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 considered).

Exclusion Criteria:

* Patients taking medication that might affect wound healing
* Patients having a condition that might affect wound healing.
* Patients with hypersensitivity or allergy to the suture material.
* Participation in another (Randomized) Clinical Trial / Clinical Study.
* Non-compliance of patient (i.e. dementia).

Primary outcomes:
measure: Surgical Wound Dehiscence rate
timeFrame: until day of suture removal (approximately 1 week after surgery)
measure: Complication rate
timeFrame: until day of suture removal (approximately 1 week after surgery)
Secondary outcomes:
measure: Complication rate
timeFrame: until day of suture removal (approximately 1 week after surgery)
measure: Pain assessment using the visual analogue scale (VAS 1-100)
timeFrame: until day of suture removal (approximately 1 week after surgery)
measure: Satisfaction of the patient using the visual analogue scale (VAS 1-100)
timeFrame: until day of suture removal (approximately 1 week after surgery)
measure: Wound healing assessment using the visual analogue scale (VAS 1-100)
timeFrame: until day of suture removal (approximately 1 week after surgery)
measure: Assessment of the handling of the suture material
timeFrame: intraoperatively
Other outcomes:
Locations:
city: Sant Cugat Del Vallès
country: Spain
facility: Facultat D'odontologia. Universitat Internacional de Catalunya
state: Catalunya
Study officials:
affiliation: Facultat D'odontologia. Universitat Internacional de Catalunya
name: Marc Quevedo Pou, Dr.
role: PRINCIPAL_INVESTIGATOR
References: