A Randomized, Self Controlled Clinical Study of Hemostatic Efficacy of the HemCon Dental Dressing - Full Text View

Purpose

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

Condition	Intervention	Phase
Tooth Extractions	Device: Hemcon Dental Dressing Device: Gauze with Pressure and/or Gelfoam	Phase 3

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Crossover Assignment Masking: Open Label Primary Purpose: Treatment
Official Title:	A Randomized, Self Controlled Clinical Study of Hemostatic Efficacy of the HemCon Dental Dressing

Further study details as provided by HemCon Medical Technologies, Inc:

Primary Outcome Measures:

Time to Hemostasis [ Time Frame: Minutes After Application ] [ Designated as safety issue: No ]
This outcome measures the time it takes in minutes for the subject's extraction site to stop bleeding. It is divided by intervention.

Secondary Outcome Measures:

Incidence of Post Surgical Sequelae [ Time Frame: 1 week post surgery ] [ Designated as safety issue: Yes ]

Enrollment:	72
Study Start Date:	June 2008
Study Completion Date:	July 2009
Primary Completion Date:	January 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: 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.	Device: Hemcon Dental Dressing The Hemcon Dental Dressing is an oral wound dressing made of chitosan.
Active Comparator: Gauze with pressure and/or Gelfoam 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 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.

Arms

Assigned Interventions

Experimental: 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.

Device: Hemcon Dental Dressing

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

Active Comparator: Gauze with pressure and/or Gelfoam

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

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.

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

Ages Eligible for Study:	14 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00707486

Locations

United States, Oregon
Rodney Nichols, DMD
Milwaukie, Oregon, United States, 97222
Jay P. Malmquist, DMD
Portland, Oregon, United States, 97221

Sponsors and Collaborators

HemCon Medical Technologies, Inc

Investigators

Principal Investigator:

Jay P Malmquist, DMD

More Information

No publications provided

Responsible Party:	HemCon Medical Technologies, Inc
ClinicalTrials.gov Identifier:	NCT00707486 History of Changes
Other Study ID Numbers:	2007-I-D-1
Study First Received:	June 27, 2008
Results First Received:	April 2, 2010
Last Updated:	December 6, 2012
Health Authority:	United States: Food and Drug Administration

Keywords provided by HemCon Medical Technologies, Inc:

Hemostasis, tooth extractions, third molar

Additional relevant MeSH terms:

Gelatin Sponge, Absorbable
Hemostatics
Coagulants

Hematologic Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 22, 2013