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

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

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.

Study Overview

• Status: Completed
• Conditions: Oral Hemorrhage
• Intervention / Treatment: Device: HEMOCOLLAGENE® : Sterile absorbable hemostatic sponges based on bovine collagen - class III MD

• Study Type: Observational
• Enrollment (Actual): 125

Contacts and Locations

Study Locations

• Belgium
  • Baulers, Belgium, 4 B-1401
    • Cabinet Dento Médical, cabinet de Nivelles
  • Bruxelles, Belgium, 1180
    • Cabinet dentaire
• France
  • Chassieu, France, 69680
    • Cabinet dentaire
  • Lyon, France, 69001
    • SCM Chirurgie Dentaire Opéra
  • Lyon, France, 69003
    • Cabinet Medical
  • Lyon, France, 69007
    • HCL-Hospices Civil de Lyon
  • Lyon, France, 69008
    • Cabinet dentaire Grange-Blanche
  • Paris, France, 75004
    • APHP- Hôpital de la Pitié Salpetrière
  • Roanne, France, 42300
    • Cabinet dentaire
  • Villefranche sur Saône, France, 69400
    • Cabinet dentaire

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 10 years and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

The study population is made with the recruitment of participating centers which included at least one patient.

The analysis will be carried out on the patients included with evaluable observation sheets . The evaluability of a form will be defined during the development of the analysis plan according to the number of missing data and the nature of missing data.

The analysis sets are defined below:

• Intented-to-treat (ITT) population: The ITT population consists of all subjects not opposed to the use of their clinical data and implanted by the HEMOCOLLAGENE® medical device. This population will be the primary population analysis for safety and efficacy.
• Per Protocol (PP): The PP population includes all the patients implanted by the medical device HEMOCOLLAGENE® without any major deviation from the protocol. Protocol violations will be graded (major / minor) when reviewing data before database lock. This population will be the secondary population analysis.

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Other
• Time Perspectives: Prospective

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Septodont
• Collaborators: Symatese; ReCOL; EndoData

Study record dates

Study Major Dates

• Study Start (Actual): November 3, 2021
• Primary Completion (Actual): March 7, 2022
• Study Completion (Actual): March 7, 2022

Study Registration Dates

• First Submitted: November 22, 2021
• First Submitted That Met QC Criteria: December 9, 2021
• First Posted (Actual): December 28, 2021

Study Record Updates

• Last Update Posted (Actual): December 28, 2022
• Last Update Submitted That Met QC Criteria: December 23, 2022
• Last Verified: December 1, 2022

More Information

Terms related to this study

• Keywords: Oral Surgery; Surgical Hemostatic
• Additional Relevant MeSH Terms: Pathologic Processes; Stomatognathic Diseases; Mouth Diseases; Oral Manifestations; Hemorrhage; Oral Hemorrhage; Coagulants; Hemostatics
• Other Study ID Numbers: HEM 2021-07; 2021-A01764-37 (Registry Identifier: French ID-RCB)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No