Clinical trial NCT00707486: A Randomized, Self Controlled Clinical Study of Hemostatic Efficacy of the HemCon Dental Dressing
Official title: A Randomized, Self Controlled Clinical Study of Hemostatic Efficacy of the HemCon Dental Dressing
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Tooth Extractions
Keywords: Hemostasis, tooth extractions, third molar
Lead sponsor: HemCon Medical Technologies, Inc
Sponsor class: INDUSTRY
First posted: 2008-07-01
Enrollment: 72
Sex: ALL
Minimum age (years): 14
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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

Detailed description: 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Time to Hemostasis
timeFrame: Minutes After Application
Secondary outcomes:
measure: Incidence of Post Surgical Sequelae
timeFrame: 1 week post surgery
Other outcomes:
Locations:
city: Milwaukie
country: United States
facility: Rodney Nichols, DMD
state: Oregon
city: Portland
country: United States
facility: Jay P. Malmquist, DMD
state: Oregon
Study officials:
name: Jay P Malmquist, DMD
role: PRINCIPAL_INVESTIGATOR
References: