Phase 3
N=72
A Randomized, Self Controlled Clinical Study of Hemostatic Efficacy of the HemCon Dental Dressing
Tooth Extractions
Bottom Line
View on ClinicalTrials.gov: NCT00707486 ↗Enrolled (actual)
72
Serious AEs
0.0%
Results posted
Jan 2013
Primary outcome: Primary: Time to Hemostasis — 1.9; 9.8; 6.0 Minutes
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Hemcon Dental Dressing (Device); Gauze with Pressure and/or Gelfoam (Device)
- Age
- Pediatric, Adult, Older Adult · 14+ yrs
- Sex
- All
- Sponsor
- HemCon Medical Technologies, Inc
- Primary completion
- Jan 2009
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Time to Hemostasis |
1.9; 9.8; 6.0 | — |
| SECONDARY Incidence of Post Surgical Sequelae |
41.2; 55.6; 41.2; 38.2; 38.9; 44.1 | — |
Summary
The purpose of this study is to determine if the HemCon Dental Dressing is effective in stopping bleeding during dental surgeries.
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.
Data sourced from ClinicalTrials.gov (NCT00707486). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.