Performance of Safety of SILKAM® Suture Material in Oral Surgery

NCT05296902 | Completed

• 1 other identifier: AAG-O-H-2038
• Study Type: observational
• Target: 105
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Tooth, Impacted; Teeth Impact; Tooth Impaction; Mucosal Wound

Keywords

Tooth distraction; Removal of impacted Teeth; Oral Surgery; Dental Implant; Observational Study

Outcome Measures

Primary Outcomes (2)

• Surgical Wound Dehiscence rate

  Pathologic process consisting of a partial or complete disruption of the layers of a surgical wound.

  until day of suture removal (approximately 1 week after surgery)

• Complication rate

  Complications rate according to the "Classification of Askar" as Grade 1 (Localized complication(s) accompanied by no adverse effects on the success of the surgery) and Grade 2 (Localized complication(s) accompanied by adverse effects on the success of the surgery).

  until day of suture removal (approximately 1 week after surgery)

Secondary Outcomes (5)

• Complication rate

  until day of suture removal (approximately 1 week after surgery)

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

  until day of suture removal (approximately 1 week after surgery)

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

  until day of suture removal (approximately 1 week after surgery)

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

  until day of suture removal (approximately 1 week after surgery)

• Assessment of the handling of the suture material

  intraoperatively

Study Arms (1)

SILKAM®

SILKAM® is a non-absorbable sterile suture material made from braided silk fibrils. It is available either undyed (white) or dyed black with hematein and is coated with refined paraffin wax or beeswax.

Device: Mucosal Closure

Interventions

Mucosal Closure DEVICE

mucosal closure in oral surgery (mucosal sutures)

SILKAM®

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 undergoing mucosal closure in oral surgery (mucosal sutures).

You may qualify if:

• 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).

You may not qualify if:

• 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).

Sponsors & Collaborators

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

Study Sites (1)

Facultat D'odontologia. Universitat Internacional de Catalunya

Sant Cugat del Vallès, Catalonia, 08195, Spain

Location

MeSH Terms

Conditions

Tooth, Impacted

Condition Hierarchy (Ancestors)

Tooth Diseases; Stomatognathic Diseases

Study Officials

• Marc Quevedo Pou, Dr.

  Facultat D'odontologia. Universitat Internacional de Catalunya

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: March 16, 2022
• First Posted: March 25, 2022
• Study Start: September 21, 2022
• Primary Completion: October 21, 2023
• Study Completion: November 16, 2023
• Last Updated: February 20, 2024

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)