Performance and Safety of the Surgical Hemostatic Agent "HEMOCOLLAGENE®" in Patients Requiring Oral Surgery
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Study Design
Outcome Measures
Primary Outcome Measures
- Hemostatic Performance at 5 minutes [5 minutes after treatment onset]
Evaluation of the stop of the bleeding 5 minutes after using HEMOCOLLAGENE®.
Secondary Outcome Measures
- 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
Eligibility Criteria
Criteria
Inclusion Criteria:
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Patient requiring oral surgery
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Patient with a bleeding requiring the use of an adjuvant hemostatic
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Patient implanted with HEMOCOLLAGENE® in dental surgery.
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Patient who signed his informed consent form
Exclusion Criteria:
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Inform Consent not signed
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Patients with acute oral infection.
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Patients with an unstable hemodynamic state (acute and/or chronic cardiovascular pathology, low arterial pressure, cardiac rhythm problem)
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Pregnant and / or breastfeeding patients.
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Patient with hypersensitivity or allergy to bovine collagen
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Cabinet Dento Médical, cabinet de Nivelles | Baulers | Belgium | 4 B-1401 | |
| 2 | Cabinet Dentaire | Bruxelles | Belgium | 1180 | |
| 3 | Cabinet dentaire | Chassieu | France | 69680 | |
| 4 | SCM Chirurgie Dentaire Opéra | Lyon | France | 69001 | |
| 5 | Cabinet Medical | Lyon | France | 69003 | |
| 6 | HCL-Hospices Civil de Lyon | Lyon | France | 69007 | |
| 7 | Cabinet dentaire Grange-Blanche | Lyon | France | 69008 | |
| 8 | APHP- Hôpital de la Pitié Salpetrière | Paris | France | 75004 | |
| 9 | Cabinet dentaire | Roanne | France | 42300 | |
| 10 | Cabinet dentaire | Villefranche sur Saône | France | 69400 |
Sponsors and Collaborators
- Septodont
- Symatese
Investigators
- Study Director: Brigitte Grosgogeat, MD, PhD, CHU de Lyon, France
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- HEM 2021-07
- 2021-A01764-37