HemorrhageNCT03783039
The SURGICEL® Powder Mild or Moderate Parenchymal or Soft Tissue Intraoperative Bleeding (China Study)
A study testing SURGICEL Powder and SURGICEL Original in people with Hemorrhage, run by Ethicon, LLC at 6 sites in China.
Trial summary
This is a single blind, randomized, prospective study comparing SURGICEL Powder with SURGICEL Original (control arm) as an adjunct to achieve hemostasis in the control of capillary, venous, and small arterial hemorrhage when ligation or other conventional methods of control are impractical or ineffective during… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hemorrhage
- What is being tested?
- SURGICEL Powder and SURGICEL Original
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 234 participants
- Where
- 6 sitesChina
- Study dates
- 15 Jan 2019to 6 May 2020
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- Adult subjects aged ≥18 years requiring elective/non-emergent open or laparoscopic general, gynecological, or cardiothoracic surgical procedures.
- Subject or authorized representative has signed the approved Informed Consent.
- Subject(s) whose platelet count is ≥100,000 per microliter and International Normalized Ratio (INR) is <1.5 prior to 24 hours of surgery.
- Presence of an appropriate TBS identified intra-operatively by the surgeon.
- Subject(s) undergoing cardiothoracic surgery with anticoagulation must have anticoagulation reversed prior to TBS identification and treatment.
Who cannot join
- Female subjects who are pregnant or nursing.
- Subject on heparin within 12 hours prior to surgery, or oral Coumadin (warfarin) and/or Factor Xa inhibitors within 3 days prior to surgery.
- Subject on antiplatelet/P2Y12 inhibitors medication 5 days prior to surgery;
- Subject is currently participating or plans to participate in any other investigational product or drug trial without prior approval from the Sponsor.
- Subjects who are known, current alcohol and/or drug abusers.
- Subjects with any pre-operative findings identified by the surgeon that may preclude conduct of the study procedure.
Show all 12Show fewer
- Subjects with any intra-operative findings identified by the surgeon that may preclude the use of study product.
- Subject with TBS in an actively infected field (Class III Contaminated or Class IV Dirty or Infected; see Appendix 1).
- TBS is on arteries or veins where application of SURGICEL Powder would present a risk of introducing the study product into an open blood vessel.
- Major arterial or venous bleeding or major defects in arteries and veins.
- TBS where silver nitrate or any other escharotic chemicals have been applied.
- TBS is in, around, or in proximity to foramina in bone, or areas of bony
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
China6 sites
Zhejiang Provincial People's Hospital
Hangzhou
Jiangsu Province Hospital
Nanjing
Nanjing Drum Tower Hospital - Nanjing University Medical School
Nanjing
Ruijin Hospital - Shanghai Jiaotong University School of Medicine
Shanghai
Shanghai Xinhua Hospital
Shanghai
The Affiliated Hospital of Xuzhou Medical University
Xuzhou
About this study
Official title: A Prospective, RCT Evaluating the Safety and Hemostatic Effectiveness of SURGICEL Powder in Controlling Mild or Moderate Parenchymal or Soft Tissue Intraoperative Bleeding During Surgery in Chinese Adult Subjects
This is a single blind, randomized, prospective study comparing SURGICEL Powder with SURGICEL Original (control arm) as an adjunct to achieve hemostasis in the control of capillary, venous, and small arterial hemorrhage when ligation or other conventional methods of control are impractical or ineffective during surgery (open, laparoscopic, or thoracoscopic) in Chinese adult subjects.
Read the detailed description
This is a single blind, randomized, prospective study comparing SURGICEL Powder with SURGICEL Original (control arm) as an adjunct to achieve hemostasis in the control of capillary, venous, and small arterial hemorrhage when ligation or other conventional methods of control are impractical or ineffective during surgery (open, laparoscopic, or thoracoscopic) in Chinese adult subjects.
After application of either SURGICEL Powder or SURGICEL Original, the target bleeding site (TBS) will be assessed for hemostasis (no detectable bleeding) at 3, 5, and 10 minutes from application and prior to initiation of final fascial closure on open surgery or port site closure in laparoscopic or thoracoscopic procedures.
All enrolled subjects will be observed post-operatively through discharge and followed up at 30 days (+14 days) and at 6 months (+/-30 days) post-surgery via phone call or office visit.
- Conditions
- Hemorrhage
- Being tested
- SURGICEL Powder, SURGICEL Original
- Keywords
- bleeding, broad area oozing bleeding, hemostat, topical hemostatic agents, adjunctive hemostats
- Medical subject headings
- Hemorrhage
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SURGICEL PowderDevice
Surgeon to perform surgical procedure according to standard of care. If randomized to SURGICEL Powder, the product will be be applied to the first appropriate TBS with mild or moderate bleeding in parenchyma or soft tissue where conventional methods of control (i.e. suture, ligature, cautery) are ineffective or impractical.
SURGICEL OriginalDevice
Surgeon to perform surgical procedure according to standard of care. If randomized to SURGICEL Original, the product will be be applied to the first appropriate TBS with mild or moderate bleeding in parenchyma or soft tissue where conventional methods of control (i.e. suture, ligature, cautery) are ineffective or impractical.
| Study group | Role | What they receive |
|---|---|---|
| SURGICEL Powder | Experimental | SURGICEL Powder is an absorbable hemostat that is oxidized regenerated cellulose in a powder form Receives: Device: SURGICEL Powder |
| SURGICEL Original | Active comparator | SURGICEL Original is an bsorbable hemostat that is oxidized regenerated cellulose in a fabric form Receives: Device: SURGICEL Original |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hemostatic Success at 5 Minutes
Percentage of subjects achieving hemostatic success at 5 minutes following study product application with no rebleeding requiring additional treatment at the Target Bleeding Site (TBS) any time prior to initiation of final fascial closure
Measured: From product application to 5 minutes following product application
Secondary outcomes (2)
Hemostatic Success at 3 Minutes
Percentage of subjects achieving hemostatic success at 3 minutes following study product application with no rebleeding requiring additional treatment at the TBS any time prior to initiation of final fascial closure
Measured: From product application to 3 minutes following product application
Hemostatic Success at 10 Minutes
Percentage of subjects achieving hemostatic success at 10 minutes following study product application with no rebleeding requiring additional treatment at the TBS any time prior to initiation of final fascial closure
Measured: From product application to 10 minutes following product application
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Dec 2018
- Study start15 Jan 2019
- Primary completion3 Dec 2019
- Study completion6 May 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for HemorrhageStudies 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
- Single blind
- Who is masked
- Participant
- Enrolment
- 234 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ethicon, LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03783039
- Sponsor's protocol ID
- BIOS_2017_02
- Status last verified
- Jun 2021
- First submitted
- 6 Dec 2018
- Last updated
- 8 Jul 2021
- Results posted
- Yes, on ClinicalTrials.gov
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 8 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, RCT Evaluating the Safety and Hemostatic Effectiveness of SURGICEL Powder in Controlling Mild or Moderate Parenchymal or Soft Tissue Intraoperative Bleeding During Surgery in Chinese Adult Subjects
- ClinicalTrials.gov ID
- NCT03783039
- Acronym / sponsor ID
- BIOS_2017_02
- Conditions
- Hemorrhage
- Keywords
- bleeding, broad area oozing bleeding, hemostat, topical hemostatic agents, adjunctive hemostats
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 234 participants (actual)
- Lead sponsor
- Ethicon, LLCIndustry (pharma, biotech, devices)
- Study start
- 15 Jan 2019 (actual)
- Primary completion
- 3 Dec 2019 (actual)
- Study completion
- 6 May 2020 (actual)
- First posted
- 20 Dec 2018 (actual)
- Results
- Posted 22 Dec 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a single blind, randomized, prospective study comparing SURGICEL Powder with SURGICEL Original (control arm) as an adjunct to achieve hemostasis in the control of capillary, venous, and small arterial hemorrhage when ligation or other conventional methods of control are impractical or ineffective during surgery (open, laparoscopic, or thoracoscopic) in Chinese adult subjects.
Detailed description
This is a single blind, randomized, prospective study comparing SURGICEL Powder with SURGICEL Original (control arm) as an adjunct to achieve hemostasis in the control of capillary, venous, and small arterial hemorrhage when ligation or other conventional methods of control are impractical or ineffective during surgery (open, laparoscopic, or thoracoscopic) in Chinese adult subjects.
After application of either SURGICEL Powder or SURGICEL Original, the target bleeding site (TBS) will be assessed for hemostasis (no detectable bleeding) at 3, 5, and 10 minutes from application and prior to initiation of final fascial closure on open surgery or port site closure in laparoscopic or thoracoscopic procedures.
All enrolled subjects will be observed post-operatively through discharge and followed up at 30 days (+14 days) and at 6 months (+/-30 days) post-surgery via phone call or office visit.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| SURGICEL Powder | Experimental | Device: SURGICEL PowderSURGICEL Powder is an absorbable hemostat that is oxidized regenerated cellulose in a powder form |
| SURGICEL Original | Active comparator | Device: SURGICEL OriginalSURGICEL Original is an bsorbable hemostat that is oxidized regenerated cellulose in a fabric form |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Adult subjects aged ≥18 years requiring elective/non-emergent open or laparoscopic general, gynecological, or cardiothoracic surgical procedures.
- Subject or authorized representative has signed the approved Informed Consent.
- Subject(s) whose platelet count is ≥100,000 per microliter and International Normalized Ratio (INR) is <1.5 prior to 24 hours of surgery.
- Presence of an appropriate TBS identified intra-operatively by the surgeon.
- Subject(s) undergoing cardiothoracic surgery with anticoagulation must have anticoagulation reversed prior to TBS identification and treatment.
Key exclusion criteria (12 listed)
- Female subjects who are pregnant or nursing.
- Subject on heparin within 12 hours prior to surgery, or oral Coumadin (warfarin) and/or Factor Xa inhibitors within 3 days prior to surgery.
- Subject on antiplatelet/P2Y12 inhibitors medication 5 days prior to surgery;
- Subject is currently participating or plans to participate in any other investigational product or drug trial without prior approval from the Sponsor.
- Subjects who are known, current alcohol and/or drug abusers.
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 |
|---|---|---|
| SURGICEL PowderSurgeon to perform surgical procedure according to standard of care. If randomized to SURGICEL Powder, the product will be be applied to the first appropriate TBS with mild or moderate bleeding in parenchyma or soft tissue where conventional methods of control (i.e. suture, ligature, cautery) are ineffective or impractical. | Device | SURGICEL Powder |
| SURGICEL OriginalSurgeon to perform surgical procedure according to standard of care. If randomized to SURGICEL Original, the product will be be applied to the first appropriate TBS with mild or moderate bleeding in parenchyma or soft tissue where conventional methods of control (i.e. suture, ligature, cautery) are ineffective or impractical. | Device | SURGICEL Original |
Primary outcome
Hemostatic Success at 5 Minutes
Time frame: From product application to 5 minutes following product application
Percentage of subjects achieving hemostatic success at 5 minutes following study product application with no rebleeding requiring additional treatment at the Target Bleeding Site (TBS) any time prior to initiation of final fascial closure
2 secondary outcomes
Hemostatic Success at 3 Minutes
Time frame: From product application to 3 minutes following product application
Hemostatic Success at 10 Minutes
Time frame: From product application to 10 minutes following product application
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jul 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
The record lists no contact. Use the official record to reach the sponsor.
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing SURGICEL Powder and SURGICEL Original in people with Hemorrhage, run by Ethicon, LLC at 6 sites in China.
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 5 inclusion and 12 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 8 Jul 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in China. 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?
Yes. Results are posted in the registry (first posted 22 Dec 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Hemostatic Success at 5 Minutes (time frame: From product application to 5 minutes following product application). 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 8 Jul 2021.