A Prospective, Single-blind, Randomized, Phase III Study to Evaluate the Safety and Efficacy of Fibrin Sealant Grifols (FS Grifols) as an Adjunct to Hemostasis During Soft Tissue Open Surgeries
Trial Snapshot
- Phase
- Phase 3
- Status
- Completed
- Sponsor
- Grifols Biologicals, LLC
- Enrollment
- 327
- Locations
- 25
- Primary Endpoint
- Percentage of Subjects Achieving Hemostasis Within 4 Minutes After Treatment Start
Study Overview
Brief Summary
This study is designed to assess the safety and efficacy of fibrin sealant (FS) Grifols in patients undergoing elective (non-emergency) soft tissue open surgery where bleeding may be present. The purpose of this study is to demonstrate that FS Grifols is not inferior to commercially-available oxidized cellulose pads (Surgicel®) in providing benefit in the time to hemostasis (i.e, the stoppage of bleeding). This study has a Preliminary Part (I) for study teams to become familiar with the application of FS Grifols and a Primary Part (II) to assess the safety and efficacy of FS Grifols. In both parts of the study, patients will be randomized in a 1:1 ratio to either FS Grifols or Surgicel.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Single (Outcomes Assessor)
Eligibility Criteria
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Hemoglobin (Hgb) ≥ 8.0 g/dL at Baseline (within 24 hours prior to surgical procedure).
- •Require elective (non-emergency), open (non-laparoscopic) surgical procedure involving soft (non-parenchymous) tissue.
- •Target bleeding site is identified on soft tissue during urologic, gynecologic or general surgery procedures: 1) Simple or radical nephrectomies, 2) Total adrenalectomies, 3) Radical prostatectomies, 4) Pyeloplasties, 5) Radical cystectomies, 6) Simple or radical hysterectomies, 7) Lymphadenectomies (in the retroperitoneal or pelvic region only), 8) Retroperitoneal tumor resections, 9) Mastopexies, and 10) Abdominoplasties.
- •A target bleeding site can be identified.
- •Target bleeding site has moderate bleeding according to the Investigator's judgment.
Exclusion Criteria
- •Require thoracic, abdominal, retroperitoneal or pelvic surgery due to trauma.
- •Infection in the anatomic surgical area.
- •History of severe (e.g. anaphylactic) reactions to blood or to any blood-derived product.
- •Previous known sensitivity to any FS Grifols component or any Surgicel® component.
- •Females who are pregnant or nursing a child at Baseline (within 24 hours prior to surgical procedure).
- •Receiving an organ transplant during the same surgical procedure.
- •Undergone a therapeutic surgical procedure within 30 days from the screening visit.
- •A target bleeding site cannot be identified.
- •The target bleeding site has a mild or severe bleeding.
- •Occurrence of major intraoperative complications that require resuscitation or deviation from the planned surgical procedure.
- •Application of any topical haemostatic material on the cut soft tissue surface identified as the target bleeding site prior to application of the study treatment.
Arms & Interventions
Fibrin Sealant (FS) Grifols
Fibrin Sealant Grifols consisting of 3 mL fibrinogen and 3 mL thrombin in separate syringes assembled on a syringe holder (6 mL of solution in total).
Intervention: Fibrin Sealant (FS) Grifols (Biological)
Surgicel®
Surgicel® is a sterile, absorbable knitted fabric prepared by the controlled oxidation of regenerated cellulose.
Intervention: Surgicel® (Device)
Outcomes
Primary Outcomes
Percentage of Subjects Achieving Hemostasis Within 4 Minutes After Treatment Start
Time Frame: From start of treatment until 4 minutes after treatment start
Subjects achieving hemostasis at the target bleeding site within 4 minutes following the start of treatment without the occurrence of re-bleeding until the completion of surgical closure.
Secondary Outcomes
- Time to Hemostasis (TTH)(From start of treatment to the end of the 10-minute observational period)
- Cumulative Proportion of Subjects Achieving Hemostasis at the Target Bleeding Site by 2 (T2), 3 (T3), 5 (T5), 7 (T7), and 10 (T10) Minutes After TStart.(From start of treatment to 2, 3, 5, 7, and 10 minutes after start of treatment)
- Treatments Failures(From start of treatment to time of completion of surgical closure.)