An observational study in Dura Mater Nick Cut or Tear, Hemostatis and Air Leakage, sponsored by Baxter Healthcare Corporation. Completed at 15 sites in 5 countries. Per ClinicalTrials.gov, last updated 2022-11-16.
Sponsored by Baxter Healthcare Corporation · Observational
To assess the clinical performance and safety of HEMOPATCH Sealing Hemostat in a post-marketing setting in cardiovascular, thoracic, urologic, neurological, and other general surgical procedures.
174 studies on the registry are indexed under Lacerations; 43 are open to participants now.
This study's enrollment of 621 is above the median of 100 across 37 observational studies indexed under Lacerations.
Browse Lacerations studies →Baxter Healthcare Corporation is the lead sponsor of 80 studies on the registry; 1 is open to participants now.
Of its 10 completed or terminated interventional studies of FDA-regulated products, 3 (30%) have results posted.
Counted across the registry records on this site, refreshed daily.
Patient who had undergone a general, cardiovascular, thoracic, urological, or neurological surgery during which the use of a patch was required to repair the dura or to achieve hemostasis, control leakage of air or other body fluid because pressure, ligature or conventional procedures were ineffective or impractical and during which Hemopatch was used according to Instructions for use.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Patients who had undergone open or minimal invasive surgical (MIS) procedures requiring the use of a patch to achieve dura repair, hemostasis, or control of leakage of air or other body fluid when pressure, ligature or other conventional procedures had been ineffective or impractical and where use of hemopatch was deemed appropriate by the surgeon according to its IFU in the following organ systems:
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Device: Hemopatch
Device: Hemopatch
Device: Hemopatch
Device: Hemopatch
Device: Hemopatch
Device: Hemopatch
Patients received product at the discretion of their surgeon.
Percentage of patients achieving hemostasis after 2 minutes of surgery
Time frame: Day 1 (up to 2 minutes postoperative)
Percentage of patients achieving hemostasis without re-bleeding at the time of surgical closure
Time frame: Day 1 (intraoperative)
Absence of air leak in lung at time of surgical closure
Time frame: Day 1 (intraoperative)
Tight closure achieved in dura mater at time of surgical closure
No leak after inspection per local standard of care
Time frame: Day 1 (intraoperative)
Number of patients with chest tube drainage >=5 days after thoracic/lung surgery
Time frame: Day 5 up to 4 weeks (postoperative)
Number of patients needing reinsertion of chest tube for pneumothorax after thoracic/lung surgery
Time frame: Up to 4 weeks (postoperative)
Number of patients with postoperative pancreatic fistulas after hepatobiliary surgery
Time frame: Up to 4 weeks (postoperative)
Duration of bile leakage after hepatobiliary surgery
Time frame: Up to 4 weeks (postoperative)
Number of patients with postoperative cerebrospinal fluid (CSF) leakage after neurological surgery
External or internal accumulation including pseudomeningocele
Time frame: Up to 4 weeks (postoperative)
Number of patients with postoperative urinary fistula formation after urological surgery
Time frame: Up to 4 weeks (postoperative)
Gastrointestinal anastomosis leakage/fistula after general surgery
Time frame: Up to 4 weeks (postoperative)
Number of patients with related Adverse Events
Time frame: Up to 4 weeks (postoperative)
Number of Hemopatch units applied
Time frame: Up to 4 weeks (postoperative)
Surgical revisions/reoperations due to bleeding, air, or other body fluid leakage
Time frame: Up to 4 weeks (postoperative)
Number of intraoperative transfusions by type and amount of blood product transfused
Unit of measure will be number of transfusion procedures and will be summarized as a single outcome measure.
Time frame: Day 1 (intraoperative)
Number of postoperative transfusions by type and amount of blood product transfused up to 72 hours after surgery
Unit of measure will be number of transfusion procedures and will be summarized as a single outcome measure.
Time frame: Up to 72 hours (postoperative)
Surgery duration
Time frame: Day 1 (intraoperative)
Length of hospital stay
Intensive Care Unit (ICU) and hospital
Time frame: Up to 4 weeks (postoperative)
Ease of product preparation
Surgeon's overall product assessment and satisfaction recorded on questionnaire.
Time frame: Day 1 (intraoperative)
Ease of product handling
Surgeon's overall product assessment and satisfaction recorded on questionnaire.
Time frame: Day 1 (intraoperative)
Assessment of product tissue adherence
Surgeon's overall product assessment and satisfaction recorded on questionnaire.
Time frame: Day 1 (intraoperative)
Surgeon's overall satisfaction of product
Surgeon's overall product assessment and satisfaction recorded on questionnaire.
Time frame: Day 1 (intraoperative)
Product characteristics appreciated by Surgeon
Surgeon's overall product assessment and satisfaction recorded on questionnaire.
Time frame: Day 1 (intraoperative)
Product characteristics liked least by Surgeon
Surgeon's overall product assessment and satisfaction recorded on questionnaire.
Time frame: Day 1 (intraoperative)
Ran from Nov 2017 to primary completion in Jan 2019, 13 months.
Of 20 observational studies under Lacerations, half reached primary completion within 25 months of starting (the median), counting those still running; a quarter within 12 and three quarters within 35. This study's 13 months is below that.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Nov 2022. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Baxter Healthcare Corporation →