Performance and Safety of the Surgical Hemostatic Agent HEMOCOLLAGENE® in Patients Requiring Oral Surgery

Study Overview
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Brief Summary
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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.

Official Title
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Observational, Multicenter, Prospective Clinical Study, Measuring the Performance and Safety of the Surgical Hemostatic Agent HEMOCOLLAGENE® in Patients Requiring Oral Surgery

Conditions
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Oral Hemorrhage

Intervention / Treatment
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* Device: HEMOCOLLAGENE® : Sterile absorbable hemostatic sponges based on bovine collagen - class III MD


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 10 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Intervention/Treatment |
| --- |
|Device: HEMOCOLLAGENE® : 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.|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Hemostatic Performance at 5 minutes | Evaluation of the stop of the bleeding 5 minutes after using HEMOCOLLAGENE®. | 5 minutes after treatment onset | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rate of overall adverse events | overall Safety assessment | From treatment onset to 30 days | 
| Rate of device related adverse events | Safety assessment relating to the medical device | From treatment onset to 30 days | 
| Wound Healing | Evaluation of the wound healing using the Landry Score (from 1 - Very Poor to 5 - Excellent) | At 30 days | 
| Ease of the use of Hemocollagene by the Dentist | 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. | At day 0, after using the treatment | 
| Rate of hemostatic time at 10 minutes in case persistant bleeding | Percentage of patients with a bleeding stopped 10 minutes after treatment onset in case of persistant bleeding | 10 minutes after treatment onset | 
| Rate of persistant bleeding | Percentage of patients with a bleeding not stopped 5 minutes after treatment onset | 5 minutes after treatment onset | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Surgical Hemostatic, Oral Surgery