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| Name | Class |
|---|---|
| B.Braun Surgical SA | INDUSTRY |
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Assessment of SILKAM® suture material in mucosal closure in oral surgery (mucosal sutures). A prospective, monocentric, single arm observational 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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Mucosal Closure | Device | mucosal closure in oral surgery (mucosal sutures) |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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) |
| Measure | Description | Time Frame |
|---|---|---|
| Complication rate | 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. |
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Inclusion Criteria:
Exclusion Criteria:
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Adult patients undergoing mucosal closure in oral surgery (mucosal sutures).
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| Name | Affiliation | Role |
|---|---|---|
| Marc Quevedo Pou, Dr. | Facultat D'odontologia. Universitat Internacional de Catalunya | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Facultat D'odontologia. Universitat Internacional de Catalunya | Sant Cugat del Vallès | Catalonia | 08195 | Spain |
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| ID | Term |
|---|---|
| D014095 | Tooth, Impacted |
| ID | Term |
|---|---|
| D014076 | Tooth Diseases |
| D009057 | Stomatognathic Diseases |
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| until day of suture removal (approximately 1 week after surgery) |
| Pain assessment using the visual analogue scale (VAS 1-100) | 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". | until day of suture removal (approximately 1 week after surgery) |
| Satisfaction of the patient using the visual analogue scale (VAS 1-100) | 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". | until day of suture removal (approximately 1 week after surgery) |
| Wound healing assessment using the visual analogue scale (VAS 1-100) | 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". | until day of suture removal (approximately 1 week after surgery) |
| Assessment of the handling of the suture material | 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. | intraoperatively |