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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

125 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-11-03

Study Completion Date

2022-03-07

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.

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Detailed Description

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Conditions

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Oral Hemorrhage

Study Design

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Observational Model Type

OTHER

Study Time Perspective

PROSPECTIVE

Interventions

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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.

Intervention Type DEVICE

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

Minimum Eligible Age

10 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No