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Completed

NCT Number: NCT05296902

Performance of Safety of SILKAM® Suture Material in Oral Surgery

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

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Key information

Conditions

Tooth, Impacted Mucosal Wound Stomatognathic Diseases Teeth Impact Tooth Diseases Tooth Impaction

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Facultat D'odontologia. Universitat Internacional de Catalunya

Sant Cugat del Vallès, Catalonia, 08195, Spain

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

Mucosal Closure

Device

mucosal closure in oral surgery (mucosal sutures)

Primary outcomes

  1. Surgical Wound Dehiscence rate

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

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

  2. Complication rate

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

    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).

Secondary outcomes

  1. Complication rate

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

    Complications rate according to the "Classification of Askar" as Grade 3 (Localized or systemic complication(s) that impairs the patient's daily routine but does not require hospitalization), Grade 4 (Localized or systemic complication(s) that impairs the patient's daily routine and requires hospitalization), Grade 5 (Localized or systemic complication(s) that inflicts irreversible damage to >1 anatomical structures), or Grade 6 (Localized or systemic complication(s) that lead to death.

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

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

    This parameter will be noted according to the Patient self assessment using the Visual Analogue Scale (VAS) which state "0" at one end representing "no pain" and "100" at the opposite end representing "maximal pain".

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

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

    This parameter will be noted according to the Patient self assessment using the Visual Analogue Scale (VAS) which state "0" at one end representing "completely satisfied" and "100" at the opposite end representing "not at all satisfied".

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

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

    This parameter will be noted by the surgeon using the Visual Analogue Scale (VAS) which state "0" at one end representing "very good wound healing" and "100" at the opposite end representing "very bad wound healing".

  5. Assessment of the handling of the suture material

    Time frame: intraoperatively

    Evaluation of the handling of the suture material in five categories (Knot security, Knot run down, Knot pull tensile strength, Tissue drag, Pliability) with the 5 evaluation levels each: 'excellent', 'very good', 'good', 'satisfied' and 'poor' transferred into the evaluation scores 5, 4, 3, 2 and 1.

Sponsors and collaborators

Lead sponsor

Aesculap AG

Industry

Collaborators

  • B.Braun Surgical SA

Registry information

Official study title

Single Center Open-Label Post Market Clinical Follow-Up (PMCF) -Study on the Performance of Safety of SILKAM® Suture Material in Oral Surgery

Acronym: SILKOS

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Mar 25, 2022
Registry last updated
Feb 20, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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