HemorrhageNCT03762200
SURGICEL® Powder in Controlling Mild or Moderate Parenchymal or Soft Tissue Intraoperative Bleeding in Adult Subjects
A study testing SURGICEL Powder in people with Hemorrhage, run by Ethicon, Inc. at 8 sites in 2 countries.
Trial summary
This is a prospective, single arm, multicentre, multispecialty, post market, clinical study evaluating SURGICEL Powder as an adjunct to achieve haemostasis (control bleeding) when conventional methods of control are impractical or ineffective during surgery (open, laparoscopic or thoracoscopic) in adult subjects (18… 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
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 103 participants
- Where
- 8 sitesin 2 countries
- Study dates
- 26 Nov 2018to 3 Jun 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
- Pre-operative:
- Adult subjects ≥ 18 years requiring elective/non-emergent open or laparoscopic general, gynaecological, cardiothoracic, or urological surgical procedures;
- Subject or authorised representative has signed the approved Informed Consent;
- Subject(s) whose International Normalised Ratio is <1.5 within 24 hours of surgery.
- Intra-operative:
- 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
- Pre-operative:
- Female subjects who are pregnant or nursing;
- Subject on anticoagulation medication (with exception of aspirin) prior to surgery. Washout periods for respective medications must be observed.
- If information is not readily available within the Instructions for Use (IFU), a conservative approach should be taken and intravenous heparin stopped 12 hours prior to surgery and 2 days prior for oral medication;
- Subject on antiplatelet/P2Y12 inhibitors medication prior to surgery. Platelet recovery times for respective medication must be observed. If information is not readily available within the IFU, a conservative approach should be taken and medication stopped 5 days prior to surgery.
- Subject is currently participating or plans to participate in any other investigational device or drug without prior approval from the Sponsor;
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- 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.
- Intra-operative:
- 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 2 in in Section 15.2)];
- 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 confine, the spinal cord, or optic nerve and chiasm;
- TBS in urological procedures where plugging (blocking) of the urethra, ureter or a catheter is possible by the study product.
Trial locations and contacts
8 sites in 2 countries.
8 sites in 2 countries
United Kingdom6 sites
Cambridge University Hospitals NHS Trust (Addenbrooke's Hospital)
Cambridge, CB2 0QQ
Golden Jubilee National Hospital
Clydebank, G81 4DY, GB
NHS Lothian (Western General Hospital)
Edinburgh, Lothian, EH4 2XU
Leeds Teaching Hospitals NHS Trust (St James's University Hospital)
Leeds, LS9 7TF
Newcastle upon Tyne NHS Foundation Trust (Freeman Hospital)
Newcastle upon Tyne, NE7 7DN
Nottingham University Hospitals NHS Trust
Nottingham, NG7 2UH
Belgium2 sites
Ziekenhuis Oost Limburg
Genk, 3600
Universitair Ziekenhuis Gent
Ghent, 9000
About this study
Official title: A Prospective, Clinical Study Evaluating the Safety and Haemostatic Effectiveness of SURGICEL® Powder, in Mild or Moderate Parenchymal or Soft Tissue Bleeding During General, Gynaecological, Urological, and Cardiothoracic Surgery
This is a prospective, single arm, multicentre, multispecialty, post market, clinical study evaluating SURGICEL Powder as an adjunct to achieve haemostasis (control bleeding) when conventional methods of control are impractical or ineffective during surgery (open, laparoscopic or thoracoscopic) in adult subjects (18 years or older).
After application of SURGICEL Powder, the Target Bleeding Site (TBS) will be assessed for haemostasis (no detectable bleeding) at 3, 5, and 10 minutes from application and prior to initiation of closure.
All enrolled subjects will be followed post-operatively through discharge and again at 30 days and 6 months post-surgery via phone call or office visit.
Read the detailed description
This is an open label, prospective, single arm, multicentre, multispecialty, post-marketing clinical study evaluating SURGICEL Powder as an adjunct to achieve haemostasis in the control of capillary, venous, and small arterial haemorrhage when ligation or other conventional methods of control are impractical or ineffective during surgery (open, laparoscopic or thoracoscopic) in adult subjects (18 years or older). Prospective subjects will be informed about the nature of the research, given the informed consent form (ICF) to read, and, if he/she understands the content, will be asked to provide consent by signing the ICF.
Screening and enrolment will continue until at least 100 evaluable subjects from approximately eight (8) investigational sites, with an appropriate mild or moderate Target Bleeding Site (TBS) are included into the study. The TBS will be the only region evaluated for the primary endpoint and all secondary effectiveness endpoints.
All enrolled subjects will be followed post-operatively through discharge, and via phone call or office visit at 30 days (+14 days) post-surgery. In addition, all enrolled subjects will receive a 6-month (+/-30 days) follow-up phone call or office visit to assess the occurrence of any serious adverse event (SAE) requiring surgical intervention and assessed as possibly related or related to the study treatment.
- Conditions
- Hemorrhage
- Being tested
- SURGICEL Powder
- 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
SURGICEL Powder is a topical absorbable hemostatic treatment made of oxidized regenerated cellulose (ORC) - plant material
| Study group | Role | What they receive |
|---|---|---|
| SURGICEL Powder - Single arm | Other | Single arm clinical trial where all qualified subjects will be treated SURGICEL Powder Receives: Device: SURGICEL Powder |
What is being measured
The primary outcome is the main question the study is designed to answer.
Haemostatic Success at 5 Minutes
Proportion of subjects achieving haemostatic success at 5 minutes following application of SURGICEL Powder with no rebleeding requiring additional treatment at the Target Bleeding Site (TBS) any time prior to initiation of final fascial closure
Measured: From application of SURGICEL Powder to 5 minutes after application
Secondary outcomes (2)
Haemostatic Success at 3 Minutes
Proportion of subjects achieving haemostatic success at 3 minutes following application of SURGICEL Powder with no rebleeding requiring additional treatment at the TBS any time prior to initiation of final fascial closure
Measured: From application of SURGICEL Powder to 3 minutes after application
Haemostatic Success at 10 Minutes
Proportion of subjects achieving haemostatic success at 10 minutes following the application of SURGICEL Powder with no rebleeding that requires additional treatment at the TBS any time prior to initiation of final fascial closure
Measured: From application of SURGICEL Powder to 10 minutes after application
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Dec 2018
- Study start26 Nov 2018
- Primary completion2 Dec 2019
- Study completion3 Jun 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.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 103 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ethicon, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03762200
- Sponsor's protocol ID
- BIOS-2017-01
- Status last verified
- Jul 2021
- First submitted
- 26 Nov 2018
- Last updated
- 26 Jul 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Publications
Al-Attar N, de Jonge E, Kocharian R, Ilie B, Barnett E, Berrevoet F. Safety and Hemostatic Effectiveness of SURGICEL(R) Powder in Mild and Moderate Intraoperative Bleeding. Clin Appl Thromb Hemost. 2023 Jan-Dec;29:10760296231190376. doi: 10.1177/10760296231190376.
PubMed 37501509
Study at a glance
From the registry record, last updated by the sponsor on 26 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Clinical Study Evaluating the Safety and Haemostatic Effectiveness of SURGICEL® Powder, in Mild or Moderate Parenchymal or Soft Tissue Bleeding During General, Gynaecological, Urological, and Cardiothoracic Surgery
- ClinicalTrials.gov ID
- NCT03762200
- Acronym / sponsor ID
- BIOS-2017-01
- Conditions
- Hemorrhage
- Keywords
- bleeding, broad area oozing bleeding, hemostat, topical hemostatic agents, adjunctive hemostats
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 103 participants (actual)
- Lead sponsor
- Ethicon, Inc.Industry (pharma, biotech, devices)
- Study start
- 26 Nov 2018 (actual)
- Primary completion
- 2 Dec 2019 (actual)
- Study completion
- 3 Jun 2020 (actual)
- First posted
- 3 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 prospective, single arm, multicentre, multispecialty, post market, clinical study evaluating SURGICEL Powder as an adjunct to achieve haemostasis (control bleeding) when conventional methods of control are impractical or ineffective during surgery (open, laparoscopic or thoracoscopic) in adult subjects (18 years or older).
After application of SURGICEL Powder, the Target Bleeding Site (TBS) will be assessed for haemostasis (no detectable bleeding) at 3, 5, and 10 minutes from application and prior to initiation of closure.
All enrolled subjects will be followed post-operatively through discharge and again at 30 days and 6 months post-surgery via phone call or office visit.
Detailed description
This is an open label, prospective, single arm, multicentre, multispecialty, post-marketing clinical study evaluating SURGICEL Powder as an adjunct to achieve haemostasis in the control of capillary, venous, and small arterial haemorrhage when ligation or other conventional methods of control are impractical or ineffective during surgery (open, laparoscopic or thoracoscopic) in adult subjects (18 years or older). Prospective subjects will be informed about the nature of the research, given the informed consent form (ICF) to read, and, if he/she understands the content, will be asked to provide consent by signing the ICF.
Screening and enrolment will continue until at least 100 evaluable subjects from approximately eight (8) investigational sites, with an appropriate mild or moderate Target Bleeding Site (TBS) are included into the study. The TBS will be the only region evaluated for the primary endpoint and all secondary effectiveness endpoints.
All enrolled subjects will be followed post-operatively through discharge, and via phone call or office visit at 30 days (+14 days) post-surgery. In addition, all enrolled subjects will receive a 6-month (+/-30 days) follow-up phone call or office visit to assess the occurrence of any serious adverse event (SAE) requiring surgical intervention and assessed as possibly related or related to the study treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| SURGICEL Powder - Single arm | Other | Device: SURGICEL PowderSingle arm clinical trial where all qualified subjects will be treated SURGICEL Powder |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Adult subjects ≥ 18 years requiring elective/non-emergent open or laparoscopic general, gynaecological, cardiothoracic, or urological surgical procedures;
- Subject or authorised representative has signed the approved Informed Consent;
- Subject(s) whose International Normalised Ratio is <1.5 within 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 (16 listed)
- Female subjects who are pregnant or nursing;
- Subject on anticoagulation medication (with exception of aspirin) prior to surgery. Washout periods for respective medications must be observed.
- If information is not readily available within the Instructions for Use (IFU), a conservative approach should be taken and intravenous heparin stopped 12 hours prior to surgery and 2 days prior for oral medication;
- Subject on antiplatelet/P2Y12 inhibitors medication prior to surgery. Platelet recovery times for respective medication must be observed. If information is not readily available within the IFU, a conservative approach should be taken and medication stopped 5 days prior to surgery.
- Subject is currently participating or plans to participate in any other investigational device or drug without prior approval from the Sponsor;
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 PowderSURGICEL Powder is a topical absorbable hemostatic treatment made of oxidized regenerated cellulose (ORC) - plant material | Device | SURGICEL Powder - Single arm |
Primary outcome
Haemostatic Success at 5 Minutes
Time frame: From application of SURGICEL Powder to 5 minutes after application
Proportion of subjects achieving haemostatic success at 5 minutes following application of SURGICEL Powder with no rebleeding requiring additional treatment at the Target Bleeding Site (TBS) any time prior to initiation of final fascial closure
2 secondary outcomes
Haemostatic Success at 3 Minutes
Time frame: From application of SURGICEL Powder to 3 minutes after application
Haemostatic Success at 10 Minutes
Time frame: From application of SURGICEL Powder to 10 minutes after application
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jul 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 37501509Al-Attar N, de Jonge E, Kocharian R, Ilie B, Barnett E, Berrevoet F. Safety and Hemostatic Effectiveness of SURGICEL(R) Powder in Mild and Moderate Intraoperative Bleeding. Clin Appl Thromb Hemost. 2023 Jan-Dec;29:10760296231190376. doi: 10.1177/10760296231190376.
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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.
8 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing SURGICEL Powder in people with Hemorrhage, run by Ethicon, Inc. at 8 sites in 2 countries.
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 7 inclusion and 16 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 26 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 8 sites in United Kingdom, Belgium. 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?
Haemostatic Success at 5 Minutes (time frame: From application of SURGICEL Powder to 5 minutes after application). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03762200, which also lists 1 linked publication.
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 26 Jul 2021.