Mucosal Wound, Teeth Impact, Tooth, Impacted, Tooth Impaction
Conditions
Keywords
Tooth distraction, Removal of impacted Teeth, Oral Surgery, Dental Implant, Observational Study
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.
Interventions
DEVICEMucosal Closure
mucosal closure in oral surgery (mucosal sutures)
Sponsors
B.Braun Surgical SA
Aesculap AG
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Surgical Wound Dehiscence rate | 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. |
| Complication rate | 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
| Measure | Time frame | Description |
|---|---|---|
| Satisfaction of the patient using the visual analogue scale (VAS 1-100) | 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. |
| Complication rate | 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. |
| Assessment of the handling of the suture material | 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. |
| Wound healing assessment using the visual analogue scale (VAS 1-100) | 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. |
| Pain assessment using the visual analogue scale (VAS 1-100) | 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. |
Countries
Spain
Outcome results
None listed