Oral Hemorrhage
Conditions
Keywords
Surgical Hemostatic, Oral Surgery
Brief summary
The aim of this study is to collect performance and safety data relating to the use and the follow-up of the HEMOCOLLAGENE® medical device in routine clinical practice from various hospitals and medical centers in oral dental surgery. Patients will The data collected from the Post-Market Clinical Follow-up study will be used to support the regulatory requirements of post-market monitoring (risk management, residual risks, instructions for use...) and to increase the manufacturer's clinical data. Patients will be followed for 1 month. Adverse events (safety) and device performance will be collected by the dentist during the routine follow-up visits.
Interventions
DEVICEHEMOCOLLAGENE® : Sterile absorbable hemostatic sponges based on bovine collagen - class III MD
HEMOCOLLAGENE® is an absorbable, sterile and hemostatic sponge, composed of type I undenatured, native and lyophilized bovine collagen (0.027 g per sponge). HEMOCOLLAGENE® will be inserted into oral sites (mainly the alveoli dental) after post-extraction or post-invasive dental surgical procedure, in case of bleeding not controled by usual hemostatic method. HEMOCOLLAGENE® will be let in place and will undergo a complete and natural absorption after several weeks.
Sponsors
Septodont
Symatese
Recherche Clinique en Odontologie (ReCOL)
EndoData
Study design
Observational model
OTHER
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
10 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Patient requiring oral surgery * Patient with a bleeding requiring the use of an adjuvant hemostatic * Patient implanted with HEMOCOLLAGENE® in dental surgery. * Patient who signed his informed consent form
Exclusion criteria
* Inform Consent not signed * Patients with acute oral infection. * Patients with an unstable hemodynamic state (acute and/or chronic cardiovascular pathology, low arterial pressure, cardiac rhythm problem) * Pregnant and / or breastfeeding patients. * Patient with hypersensitivity or allergy to bovine collagen
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Hemostatic Performance at 5 minutes | 5 minutes after treatment onset | Evaluation of the stop of the bleeding 5 minutes after using HEMOCOLLAGENE®. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Rate of overall adverse events | From treatment onset to 30 days | overall Safety assessment |
| Rate of device related adverse events | From treatment onset to 30 days | Safety assessment relating to the medical device |
| Wound Healing | At 30 days | Evaluation of the wound healing using the Landry Score (from "1 - Very Poor" to "5 - Excellent") |
| Ease of the use of Hemocollagene by the Dentist | At day 0, after using the treatment | Satisfaction of the dentist on the use and the quality of HEMOCOLLAGENE® : * Data relating to the hemostatic agent HEMOCOLLAGENE® (number, reference, quality before and during use). * The technique for using HEMOCOLLAGENE® (cutting before or after application, removal or not for hemostasis, fixing). * The intraoperative satisfaction of the practitioner. |
| Rate of hemostatic time at 10 minutes in case persistant bleeding | 10 minutes after treatment onset | Percentage of patients with a bleeding stopped 10 minutes after treatment onset in case of persistant bleeding |
| Rate of persistant bleeding | 5 minutes after treatment onset | Percentage of patients with a bleeding not stopped 5 minutes after treatment onset |
Countries
Belgium, France
Contacts
STUDY_DIRECTORBrigitte Grosgogeat, MD, PhD
CHU de Lyon, France
Outcome results
None listed