A Randomized, Self Controlled Clinical Study of Hemostatic Efficacy of the HemCon Dental Dressing

The HemCon® Bandage has been successfully used to achieve hemostasis in patients with high systolic pressure, high blood volume wounds, and to promote hemostasis on a massive scale compared to the hemostasis requirements of oral surgery wounds. Therefore, a human clinical trial has recently been completed evaluating the efficacy of using the HemCon® Bandage in a smaller finished size for dental extraction and other oral surgery sites. The HemCon® Bandage was proven to be significantly better at promoting hemostasis of oral surgery wounds than the control (cotton gauze or Gelfoam) in all subjects tested. All HemCon® Bandage sites achieved hemostasis faster than the control sites. Based on this data, a 510(k) was submitted and has received FDA clearance for the HemCon® Dental Dressing to be used as an oral wound dressing intended as a physical barrier for temporary protection of oral mucosal tissue and to provide pain relief.

This study evaluates the FDA cleared HemCon® Dental Dressing for use in hemostasis of soft oral tissue subsequent to dental surgical procedures such as tooth extractions excluding procedures involving primary closure of the HemCon® Dental Dressing within the oral wound.

Inclusion criteria

• Patients requiring 2 or 4 3rd molar tooth extraction procedures.
• Index pairing must reflect anatomically similar extraction locations, i.e., for 2 extractions both must be upper or both must be lower extractions.
• Patients must be 14 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. Additional follow-up visits may be scheduled at the discretion of the surgeon based on the severity of particular patient cases or the patient's need for earlier follow-up.
• Extraction sites do not require primary closure or suturing
• Willingness and ability to provide informed consent/ assent for participation
• Patients with seafood allergies
• Patients who have discontinued the use of anticoagulant medications (e.g., aspirin, coumadin, Plavix, etc.) for a minimum of 3 days prior to their planned surgical visit.

Exclusion criteria

• Scheduled to undergo a surgical procedure other than 3rd molar tooth extractions
• Scheduled to undergo 2 extractions whereby one is an upper 3rd molar and the other is a lower 3rd molar. These will not reflect a proper index pairing for statistical calculations and data analysis based on anatomical similarities.
• Extraction procedures are expected to require primary closure or suturing of the HemCon® Dental Dressing within the oral wound.
• Unable or unwilling to provide informed consent/ assent for participation as a subject
• Patients who are currently taking anticoagulant medications (e.g., aspirin, coumadin, Plavix, etc.) or have discontinued their anticoagulant medications less than 3 days prior to their surgical visit.
• Patients who are undergoing bisphosphonate therapy.