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

Study Overview
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Brief Summary
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The purpose of this study is to determine if the HemCon Dental Dressing is effective in stopping bleeding during dental surgeries.

Detailed Description
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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.

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

Conditions
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Tooth Extractions

Intervention / Treatment
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* Device: Hemcon Dental Dressing
* Device: Gauze with Pressure and/or Gelfoam


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 14 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Hemcon Dental Dressing<br>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. | Device: Hemcon Dental Dressing<br>* The Hemcon Dental Dressing is an oral wound dressing made of chitosan.<br>|
| Active Comparator: Gauze with pressure and/or Gelfoam<br>Post operative care for oral surgery subjects consists of the subject biting on sterile cotton gauze to provide pressure to the extraction site. A common alternative practice involves the placement of Gelfoam (with or without antibiotic/steroid medication) into the extraction socket prior to application of the sterile gauze pressure dressing. This treatment was chosen as the study control to compare the HemCon Dental Dressing to the standard of care for oral surgery subjects, including the use of cotton gauze and/or Gelfoam to control post operative bleeding. | Device: Gauze with Pressure and/or Gelfoam<br>* Common practice for oral surgery patients involves the use of sterile dressing over the extraction site. The subject will provide the pressure by biting down on the sterile gauze. As previously discussed, other practices involve the use of Gelfoam prior to application of sterile gauze.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time to Hemostasis | This outcome measures the time it takes in minutes for the subject's extraction site to stop bleeding. It is divided by intervention. | Minutes After Application | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of Post Surgical Sequelae |  | 1 week post surgery | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Hemostasis, tooth extractions, third molar