Dental Extractions in Patients Under Dual Antiplatelet Therapy (DUALex)

University of Sao Paulo General Hospital

Status: Completed

Conditions: Blood Coagulation Disorders

Treatments: Device: Oxidized Cellulose Gauze; Device: HemCon Dental Dressing

Study type: Interventional

Funder types: Other

Identifiers

NCT02918045

DUALex

Details and patient eligibility

About

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.

Full 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.

Enrollment: 60 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Single Blind

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60 participants in 2 patient groups

Hemcon Dental Dressing

Experimental group

Description:

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.

Treatment:

Device: HemCon Dental Dressing

Oxidized Cellulose Gauze

Active Comparator group

Description:

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.

Treatment:

Device: Oxidized Cellulose Gauze