Blood Coagulation DisordersDUALexNCT02918045
Dental Extractions in Patients Under Dual Antiplatelet Therapy
A study testing HemCon Dental Dressing and Oxidized Cellulose Gauze in people with Blood Coagulation Disorders, run by University of Sao Paulo General Hospital at 1 site in Brazil.
Trial summary
The purpose of this study is to compare two hemostatic agents in patients under dual antiplatelet therapy using the intraoral bleeding time after dental extractions. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Blood Coagulation Disorders
- What is being tested?
- HemCon Dental Dressing and Oxidized Cellulose Gauze
- Type of treatment
- Pill or oral medicine, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteBrazil
- Study dates
- 11 Apr 2017to 23 Jul 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients requiring two or more dental extraction procedures.
- Patients must be under dual antiplatelet therapy of any kind.
- Patients must be 18 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.
- Extraction sites do not require primary closure of suturing.
- Willingness and ability to provide informed consent
Who cannot join
- Patients who are currently undertaking other anticoagulant medications (e.g., aspirin, coumadin, heparin) or have discontinued their anticoagulant medications.
- History of heart attack in less than 1 week.
- Patients with seafood allergy.
- Unable of unwilling to provide informed consent.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Dental Extractions in Patients Under Dual Antiplatelet Therapy: Comparison of Two Local Hemostatic Techniques
The purpose of this study is to compare two hemostatic agents in patients under dual antiplatelet therapy using the intraoral bleeding time after dental extractions.
Read the detailed description
Postoperative hemostasis is a fundamental patient management issue in the oral and maxillofacial surgery setting. The risk of excessive bleeding prompts physicians to stop multiple antiplatelet agents before minor surgery, which puts coronary stenting patients at risk for adverse thrombotic events. Adequate hemostasis must be achieved in order to make oral surgeries possible for these patients without discontinuation of the antiplatelet regimen. The HemCon Dental Dressing (HemCon Medical Technologies, Inc, Beaverton, OR) is a novel chitosan-based hemostatic agent which may greatly improve upon the efficacy of wound healing and hemostasis both in extent and time for minor oral surgeries. Dental extractions will be performed in patients under dual antiplatelet therapy without altering their medication regimen. All patients will require to have two or more surgical sites so they will have internal surgical control sites. Cutaneous bleeding time and platelet aggregation tests will be obtained prior to extractions. The primary hemostasis will be evaluated by measuring the intraoral bleeding time after each extraction and further bleeding and healing outcomes will be ascertain by phone questionaires and clinical evaluations. The aim of this study is to evaluate the effectiveness of HemCon Dental Dressing in controlling post extraction bleeding and to ascertain its role in healing of extraction wounds compared to a standard haemostasis method.
- Conditions
- Blood Coagulation Disorders
- Being tested
- HemCon Dental Dressing, Oxidized Cellulose Gauze
- Keywords
- Tooth Extraction, Surgical Hemostasis, Platelet Aggregation Inhibitors, Chitosan
- Medical subject headings
- Blood Coagulation Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HemCon Dental DressingDevice
The Hemcon Dental Dressing is an oral wound dressing made of chitosan.
Oxidized Cellulose GauzeDevice
Also called Surgicel (Ethicon, Inc, San Angelo, TX)
A common hemostatic measure after dental extractions placed into the extraction socket.
| Study group | Role | What they receive |
|---|---|---|
| Hemcon Dental Dressing | Experimental | 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. Receives: Device: HemCon Dental Dressing |
| Oxidized Cellulose Gauze | Active comparator | A common hemostatic measure after dental extractions involves the placement of an absorbable oxidized cellulose gauze Surgicel (Ethicon, Inc, San Angelo, TX) into the extraction socket. This treatment was chosen as the study control to compare the HemCon Dental Dressing to the standard local hemostatic care for oral surgery subjects. Receives: Device: Oxidized Cellulose Gauze |
What is being measured
The primary outcome is the main question the study is designed to answer.
Primary bleeding
Primary bleeding will be evaluated by recording the intra-oral bleeding time. The extraction site will be observed for 2 min without gauze in place. At the end of 2 min, gauze is placed over the extraction site to remove blood extending beyond the tooth socket. After blotting the extraction site, any bleeding that extends beyond the crest of the socket will be recorded as a positive test result (i.e., onto surrounding gingival tissues) during an observation period of 1 min. This same procedure was performed at 5, 8, 11, 14, and 20 min after the extraction. Intra-oral bleeding time is defined as the length of time for bleeding to cease to extend beyond the tooth socket.
Measured: Intraoperative
Secondary outcomes (1)
Point-of-care platelet function test
Blood platelet function plays a pivotal role in hemostasis during surgery and following traumatic injuries. The ability to assess platelet function before the intervention is desirable in patients undergoing dental extraction procedures. A point-of-care platelet function test (Multiplate - Roche Diagnostics, Mannheim, Germany) will be performed the morning before dental extraction to assess platelet function inhibition due to dual antiplatelet therapy.
Measured: Day before dental extraction
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Sep 2016 (estimated)
- Study start11 Apr 2017
- Primary completion16 Jul 2019
- Study completion23 Jul 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Blood Coagulation DisordersStudies of the same condition, open and under way.
- More trials run by University of Sao Paulo General HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- Single-blind, Randomized, Split-mouth
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Sao Paulo General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Bruno Guardieiro, University of Sao Paulo General Hospital
- Investigators
- Itamara LI Neves, PhD, Principal investigator, University of Sao PauloJosé C Nicolau, PhD, Study director, University of Sao Paulo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02918045
- Sponsor's protocol ID
- DUALex
- Acronym
- DUALex
- Status last verified
- Sep 2019
- First submitted
- 21 Sep 2016
- Last updated
- 10 Sep 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 10 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Dental Extractions in Patients Under Dual Antiplatelet Therapy: Comparison of Two Local Hemostatic Techniques
- ClinicalTrials.gov ID
- NCT02918045
- Acronym / sponsor ID
- DUALex / DUALex
- Conditions
- Blood Coagulation Disorders
- Keywords
- Tooth Extraction, Surgical Hemostasis, Platelet Aggregation Inhibitors, Chitosan
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- University of Sao Paulo General HospitalUniversity, hospital or other
- Study start
- 11 Apr 2017 (actual)
- Primary completion
- 16 Jul 2019 (actual)
- Study completion
- 23 Jul 2019 (actual)
- First posted
- 28 Sep 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to compare two hemostatic agents in patients under dual antiplatelet therapy using the intraoral bleeding time after dental extractions.
Detailed description
Postoperative hemostasis is a fundamental patient management issue in the oral and maxillofacial surgery setting. The risk of excessive bleeding prompts physicians to stop multiple antiplatelet agents before minor surgery, which puts coronary stenting patients at risk for adverse thrombotic events. Adequate hemostasis must be achieved in order to make oral surgeries possible for these patients without discontinuation of the antiplatelet regimen. The HemCon Dental Dressing (HemCon Medical Technologies, Inc, Beaverton, OR) is a novel chitosan-based hemostatic agent which may greatly improve upon the efficacy of wound healing and hemostasis both in extent and time for minor oral surgeries. Dental extractions will be performed in patients under dual antiplatelet therapy without altering their medication regimen. All patients will require to have two or more surgical sites so they will have internal surgical control sites. Cutaneous bleeding time and platelet aggregation tests will be obtained prior to extractions. The primary hemostasis will be evaluated by measuring the intraoral bleeding time after each extraction and further bleeding and healing outcomes will be ascertain by phone questionaires and clinical evaluations. The aim of this study is to evaluate the effectiveness of HemCon Dental Dressing in controlling post extraction bleeding and to ascertain its role in healing of extraction wounds compared to a standard haemostasis method.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- Single-blind, Randomized, Split-mouth
| Arm | Type | Receives |
|---|---|---|
| Hemcon Dental Dressing | Experimental | Device: HemCon Dental DressingThe 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. |
| Oxidized Cellulose Gauze | Active comparator | Device: Oxidized Cellulose GauzeA common hemostatic measure after dental extractions involves the placement of an absorbable oxidized cellulose gauze Surgicel (Ethicon, Inc, San Angelo, TX) into the extraction socket. This treatment was chosen as the study control to compare the HemCon Dental Dressing to the standard local hemostatic care for oral surgery subjects. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Patients requiring two or more dental extraction procedures.
- Patients must be under dual antiplatelet therapy of any kind.
- Patients must be 18 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.
- Extraction sites do not require primary closure of suturing.
Key exclusion criteria (4 listed)
- Patients who are currently undertaking other anticoagulant medications (e.g., aspirin, coumadin, heparin) or have discontinued their anticoagulant medications.
- History of heart attack in less than 1 week.
- Patients with seafood allergy.
- Unable of unwilling to provide informed consent.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| HemCon Dental DressingThe Hemcon Dental Dressing is an oral wound dressing made of chitosan. | Device | Hemcon Dental Dressing |
| Oxidized Cellulose GauzeAlso: Surgicel (Ethicon, Inc, San Angelo, TX)A common hemostatic measure after dental extractions placed into the extraction socket. | Device | Oxidized Cellulose Gauze |
Primary outcome
Primary bleeding
Time frame: Intraoperative
Primary bleeding will be evaluated by recording the intra-oral bleeding time. The extraction site will be observed for 2 min without gauze in place. At the end of 2 min, gauze is placed over the extraction site to remove blood extending beyond the tooth socket. After blotting the extraction site, any bleeding that extends beyond the crest of the socket will be recorded as a positive test result (i.e., onto surrounding gingival tissues) during an observation period of 1 min. This same procedure was performed at 5, 8, 11, 14, and 20 min after the extraction. Intra-oral bleeding time is defined as the length of time for bleeding to cease to extend beyond the tooth socket.
1 secondary outcome
Point-of-care platelet function test
Time frame: Day before dental extraction
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Sep 2019.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Itamara LI Neves, PhD principal investigator
University of Sao Paulo
José C Nicolau, PhD study director
University of Sao Paulo
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing HemCon Dental Dressing and Oxidized Cellulose Gauze in people with Blood Coagulation Disorders, run by University of Sao Paulo General Hospital at 1 site in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Sep 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Primary bleeding (time frame: Intraoperative). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Sep 2019.