Dental Extractions in Patients Under Dual Antiplatelet Therapy

NCT ID: NCT02918045

Last Updated: 2019-09-10

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-04-11
• Study Completion Date: 2019-07-23

Brief Summary

The purpose of this study is to compare two hemostatic agents in patients under dual antiplatelet therapy using the intraoral bleeding time after dental extractions.

Detailed Description

Postoperative hemostasis is a fundamental patient management issue in the oral and maxillofacial surgery setting. The risk of excessive bleeding prompts physicians to stop multiple antiplatelet agents before minor surgery, which puts coronary stenting patients at risk for adverse thrombotic events. Adequate hemostasis must be achieved in order to make oral surgeries possible for these patients without discontinuation of the antiplatelet regimen. The HemCon Dental Dressing (HemCon Medical Technologies, Inc, Beaverton, OR) is a novel chitosan-based hemostatic agent which may greatly improve upon the efficacy of wound healing and hemostasis both in extent and time for minor oral surgeries. Dental extractions will be performed in patients under dual antiplatelet therapy without altering their medication regimen. All patients will require to have two or more surgical sites so they will have internal surgical control sites. Cutaneous bleeding time and platelet aggregation tests will be obtained prior to extractions. The primary hemostasis will be evaluated by measuring the intraoral bleeding time after each extraction and further bleeding and healing outcomes will be ascertain by phone questionaires and clinical evaluations. The aim of this study is to evaluate the effectiveness of HemCon Dental Dressing in controlling post extraction bleeding and to ascertain its role in healing of extraction wounds compared to a standard haemostasis method.

Conditions

Blood Coagulation Disorders

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Hemcon Dental Dressing

The HemCon® Bandage is an FDA-cleared chitosan-based flat bandage that controls severe arterial bleeding from traumatic injuries. In comparison to traditional bandages, the HemCon® Bandage provides superior control of bleeding, wound site adhesiveness, multiple injury site usage, biocompatibility and provides a barrier to infective agents.

Group Type: EXPERIMENTAL

HemCon Dental Dressing

Intervention Type: DEVICE

The Hemcon Dental Dressing is an oral wound dressing made of chitosan.

Oxidized Cellulose Gauze

A common hemostatic measure after dental extractions involves the placement of an absorbable oxidized cellulose gauze Surgicel (Ethicon, Inc, San Angelo, TX) into the extraction socket. This treatment was chosen as the study control to compare the HemCon Dental Dressing to the standard local hemostatic care for oral surgery subjects.

Group Type: ACTIVE_COMPARATOR

Oxidized Cellulose Gauze

Intervention Type: DEVICE

A common hemostatic measure after dental extractions placed into the extraction socket.

Interventions

HemCon Dental Dressing

The Hemcon Dental Dressing is an oral wound dressing made of chitosan.

Intervention Type: DEVICE

Oxidized Cellulose Gauze

A common hemostatic measure after dental extractions placed into the extraction socket.

Intervention Type: DEVICE

Other Intervention Names

Surgicel (Ethicon, Inc, San Angelo, TX)

Eligibility Criteria

Inclusion Criteria

• Patients requiring two or more dental extraction procedures.
• Patients must be under dual antiplatelet therapy of any kind.
• Patients must be 18 years of age or older.
• Patients must be available for a minimum of one post operative evaluation to be scheduled at the time of the procedure approximately 7 days post surgery.
• Extraction sites do not require primary closure of suturing.
• Willingness and ability to provide informed consent

Exclusion Criteria

• Patients who are currently undertaking other anticoagulant medications (e.g., aspirin, coumadin, heparin) or have discontinued their anticoagulant medications.
• History of heart attack in less than 1 week.
• Patients with seafood allergy.
• Unable of unwilling to provide informed consent.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Sao Paulo General Hospital

OTHER

Sponsor Role: lead

Responsible Party

Bruno Guardieiro

PhD degree student

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Itamara LI Neves, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Sao Paulo

José C Nicolau, PhD

Role: STUDY_DIRECTOR

University of Sao Paulo

Locations

Instituto do Coração (InCor HCFMUSP)

São Paulo, , Brazil

Countries

Brazil

Other Identifiers

DUALex

Identifier Type: -

Identifier Source: org_study_id