Postpartum BleedingNCT01373801
Hemcon© Bandage for Postpartum Bleeding Due to the Multiple Vaginal Lacerations
A study testing The HemCon GuardaCare in people with Postpartum Bleeding and Vaginal Lacerations, run by Soroka University Medical Center at 1 site in Israel.
Trial summary
The objective of the study is to assess the safety and efficacy of the HemCon GuardaCareXR compared to standard bandaging in subjects with post partum hemorrhage as a result of cervical and vaginal lacerations. The primary endpoint will be a cessation of bleeding at 30 minutes after insertion of the dressing. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Postpartum Bleeding, Vaginal Lacerations, Cervical Lacerations
- What is being tested?
- The HemCon GuardaCare
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 85 participants
- Where
- 1 siteIsrael
- Study dates
- Jul 2011to Jul 2012
- 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
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Signed Informed Consent
- Age≥18 year
- Two or more 2nd degree vaginal lacerations , 3rd degree vaginal lacerations and cervical laceration
Who cannot join
- Subjects undertaking anticoagulation treatment
- Pre-existing coagulopathy
- Massive uncontrolled bleeding requiring blood transfusions/urgent vascular surgery.
- Systolic blood pressure <90mmHg
- Shellfish allergy
Trial locations and contacts
1 site in 1 country.
Israel1 site, 1 recruiting
- Recruiting
OB\GYN Soroka University Medical Center
Beersheba, 84101
Ayala Dvir, MsC, 972-8-62444245, ayaladv@clalit.org.il
Arnon Wiznitzer, MD
About this study
Official title: THE EFFICACY AND SAFETY OF HEMCON© BANDAGE FOLLOWING SURGICAL REPAIR IN MANAGEMENT OF POSTPARTUM BLEEDING DUE TO THE MULTIPLE VAGINAL LACERATIONS
The objective of the study is to assess the safety and efficacy of the HemCon GuardaCareXR compared to standard bandaging in subjects with post partum hemorrhage as a result of cervical and vaginal lacerations. The primary endpoint will be a cessation of bleeding at 30 minutes after insertion of the dressing.
- Being tested
- The HemCon GuardaCare, Control
- Keywords
- Postpartum women, after surgical repair of vaginal and cervical lacerations
- Medical subject headings
- Postpartum Hemorrhage
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
The HemCon GuardaCareDevice
The HemCon GuardaCare (HemCon Medical Technologies Inc., Portland, OR) is a hemostatic dressing made of chitosan, a complex carbohydrate derived from chitin from shellfish and is designed as a hemostatic dressing, and a topical antimicrobial dressing. GuardaCare contains no pro-clotting agents, providing a safe and localized hemostatic solution and is latex free and sterile.
ControlDevice
Standard packing gauze roll bandage.
| Study group | Role | What they receive |
|---|---|---|
| Control | Active comparator | Not described Receives: Device: The HemCon GuardaCare; Device: Control |
| GuardaCare | Experimental | Not described Receives: Device: The HemCon GuardaCare |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cessation of bleeding after a 30 minutes
The primary endpoint is a cessation of bleeding after a 30 minute period. Evaluation of bleeding will be performed by an independent evaluator, who will determine if the bleeding has stopped.
Measured: 30 minutes
Secondary outcomes (3)
Safety composite endpoint
Rate of the safety composite (any of the following):
- Anaphylaxis or allergic reaction
- Recurrent Hospitalization
- Serious adverse events
- Need for the repeated surgical intervention
- Need for blood products transfusion
- Local Infection In addition individual rates of the components will be reported
Measured: 7 days
Device Success
Device success defined as a cessation of bleeding at 6 hours using only the allocated device.
Measured: 6 hours
Procedural success
Procedural success defined as a cessation of bleeding at 6 hours.
Measured: 6 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jun 2011 (estimated)
- Study startJul 2011
- Primary completionJul 2012 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Postpartum BleedingStudies of the same condition, open and under way.
- 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
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 85 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Soroka University Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- HemCon Medical Technologies, Inc
- Investigators
- Arnon Wiznitzer, M.D, Principal investigator, Soroka University Medical CenterVictor Novack, M.D. PhD, Principal investigator, Soroka University Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01373801
- Sponsor's protocol ID
- sor517911ctil
- Status last verified
- Apr 2011
- First submitted
- 13 Jun 2011
- Last updated
- 10 Aug 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Aug 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- THE EFFICACY AND SAFETY OF HEMCON© BANDAGE FOLLOWING SURGICAL REPAIR IN MANAGEMENT OF POSTPARTUM BLEEDING DUE TO THE MULTIPLE VAGINAL LACERATIONS
- ClinicalTrials.gov ID
- NCT01373801
- Acronym / sponsor ID
- sor517911ctil
- Keywords
- Postpartum women, after surgical repair of vaginal and cervical lacerations
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 85 participants (estimated)
- Lead sponsor
- Soroka University Medical CenterUniversity, hospital or other
- Collaborators
- HemCon Medical Technologies, Inc
- Study start
- Jul 2011
- Primary completion
- Jul 2012 (estimated)
- First posted
- 15 Jun 2011 (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 objective of the study is to assess the safety and efficacy of the HemCon GuardaCareXR compared to standard bandaging in subjects with post partum hemorrhage as a result of cervical and vaginal lacerations. The primary endpoint will be a cessation of bleeding at 30 minutes after insertion of the dressing.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control | Active comparator | Device: The HemCon GuardaCare, Device: Control |
| GuardaCare | Experimental | Device: The HemCon GuardaCare |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Signed Informed Consent
- Age≥18 year
- Two or more 2nd degree vaginal lacerations , 3rd degree vaginal lacerations and cervical laceration
Key exclusion criteria (5 listed)
- Subjects undertaking anticoagulation treatment
- Pre-existing coagulopathy
- Massive uncontrolled bleeding requiring blood transfusions/urgent vascular surgery.
- Systolic blood pressure <90mmHg
- Shellfish allergy
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 |
|---|---|---|
| The HemCon GuardaCareThe HemCon GuardaCare (HemCon Medical Technologies Inc., Portland, OR) is a hemostatic dressing made of chitosan, a complex carbohydrate derived from chitin from shellfish and is designed as a hemostatic dressing, and a topical antimicrobial dressing. GuardaCare contains no pro-clotting agents, providing a safe and localized hemostatic solution and is latex free and sterile. | Device | Control, GuardaCare |
| ControlStandard packing gauze roll bandage. | Device | Control |
Primary outcome
Cessation of bleeding after a 30 minutes
Time frame: 30 minutes
The primary endpoint is a cessation of bleeding after a 30 minute period. Evaluation of bleeding will be performed by an independent evaluator, who will determine if the bleeding has stopped.
3 secondary outcomes
Safety composite endpoint
Time frame: 7 days
Device Success
Time frame: 6 hours
Procedural success
Time frame: 6 hours
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Aug 2011.
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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.
Arnon Wiznitzer, M.D principal investigator
Soroka University Medical Center
Victor Novack, M.D. PhD principal investigator
Soroka University Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing The HemCon GuardaCare in people with Postpartum Bleeding and Vaginal Lacerations, run by Soroka University Medical Center at 1 site in Israel.
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 3 inclusion and 5 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: status not confirmed, as of the sponsor's last update on 10 Aug 2011. 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 Israel. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Arnon Wiznitzer, MD (972-8-6400774, arnonw@clalit.org.il), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cessation of bleeding after a 30 minutes (time frame: 30 minutes). 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 Aug 2011.