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FloSeal — Flowable Gelatin-Thrombin Hemostatic Matrix

FloSeal is a flowable hemostatic matrix that combines bovine-derived cross-linked gelatin granules with human thrombin to deliver a hybrid passive-plus-active hemostatic in a single syringe-based product. It is the go-to agent for diffuse oozing on irregular surfaces — the renal bed after partial nephrectomy, the pelvic sidewall after lymphadenectomy, the retropubic space after complex reconstruction — particularly in patients with impaired clotting capacity (heparinization, coagulopathy).[1][2]


Composition and Mechanism

ComponentRole
Gelatin matrix (bovine)Passive mechanical scaffold; contact-activates platelets; swells to fill irregular cavities
Human thrombinConverts fibrinogen → fibrin directly; bypasses the intrinsic/extrinsic coagulation cascade
Combined effectPassive matrix + active thrombin = hemostasis independent of the patient's own coagulation status

Mechanism sequence

  1. Syringe delivers flowable gel onto the bleeding surface
  2. Gelatin granules swell (up to 20%) as they absorb blood and tissue fluid
  3. Thrombin converts local fibrinogen → fibrin immediately, catalyzing clot formation
  4. Mechanical tamponade of the bleeding surface as the gel conforms to irregular anatomy
  5. Matrix resorbs over 6–8 weeks

GU Reconstruction Applications

1. Partial nephrectomy renal bed

The highest-yield application:[1][2]

  • Combined with sliding-clip renorrhaphy (suture hemostasis of the parenchymal bed)
  • FloSeal fills the tumor excision defect, controlling diffuse parenchymal oozing after tumor removal
  • Shorter warm ischemia time, reduced need for additional cautery, no disruption of adjacent parenchyma
  • Used in both open and robotic partial nephrectomy — the syringe tip is trocar-compatible

2. Pelvic sidewall / lymphadenectomy

  • After pelvic lymph node dissection during radical cystectomy, prostatectomy, or deep endometriosis resection
  • Controls capillary and small-venous oozing without cautery near iliac vessels or obturator nerve

3. Retropubic space

  • After complex bladder-neck reconstruction (Y-V plasty, complex pelvic fistula repair)
  • After radical prostatectomy when anterior urethral / puboprostatic ligament dissection has created a raw surface

4. Deep pelvic dissection

  • Presacral venous plexus bleeding
  • Pelvic sidewall after extensive dissection
  • Post-exenteration bleeding

5. High-risk patient populations

  • Heparinized patients — the active thrombin component works independently of heparin-affected clotting
  • Coagulopathic patients — cirrhotic patients, patients on DOACs, thrombocytopenic patients
  • Radiated tissue — where tissue quality is poor and standard suturing is unreliable

Preparation and Application

Preparation (at the scrub table)

  1. Reconstitute the thrombin (~5 minutes)
  2. Combine with the gelatin matrix in the supplied syringe connector
  3. Mix back-and-forth between the two syringes ~20 times until homogeneous
  4. Attach the applicator tip
  5. Ready for use

Application

  1. Dry the surgical field as much as possible (suction nearby; dry the surface with gauze)
  2. Apply the gel directly to the bleeding surface with the applicator tip
  3. Tamponade with a dry sponge gently for 2 minutes
  4. Irrigate gently to remove excess
  5. Check for hemostasis; repeat if needed

Volume

  • Standard kit: 5 mL, 10 mL sizes
  • Typical GU application: 2–5 mL covers a moderate renal bed or pelvic sidewall
  • Large irregular cavities may require 10 mL or repeat application

Advantages

  • Active + passive combined — effective even in coagulopathic / heparinized patients where passive matrices underperform
  • Conforms to irregular surfaces — flowable delivery reaches crevices inaccessible to sheet products
  • Trocar-compatible — direct laparoscopic / robotic application
  • Excellent for parenchymal surfaces (renal bed, liver in GU-adjacent trauma)
  • Strong evidence base in partial nephrectomy and spine surgery

Limitations

  • Cost — FloSeal is substantially more expensive than Surgicel or Arista (~$200–500/kit)
  • Swelling — 20% expansion; can compress nerves or narrow spaces (use sparingly in spinal canal, pelvic sidewall near nerves)
  • Bovine gelatin origin — rare anaphylaxis reported; contraindicated in patients with known bovine allergy
  • Not for intravascular use — thrombin can cause pulmonary embolism if injected into a vessel
  • Preparation time — reconstitution takes a few minutes; not instantly available if unanticipated bleeding
  • Urinary-tract collecting-system contact — as with other hemostatic matrices, avoid direct contact with the urinary collecting system (stone nidus concern, though shorter-duration than Surgicel/Gelfoam)

Evidence Base

FloSeal has substantial evidence in urology:

  • Multiple studies in robotic and open partial nephrectomy demonstrate reduced operative bleeding, shorter warm ischemia, and reduced need for transfusion
  • Pelvic reconstruction and radical cystectomy series show reduced overall operative blood loss with routine use
  • Spine surgery data (not GU but foundational) established FloSeal as the benchmark active hemostatic against which newer products are compared

See Also


References

1. Hidas G, Kastin A, Mullerad M, Shental J, Moskovitz B, Nativ O. Sutureless nephron-sparing surgery: use of albumin glutaraldehyde tissue adhesive (BioGlue). Urology. 2006;67(4):697–700. doi:10.1016/j.urology.2005.10.064

2. Msezane LP, Katz MH, Gofrit ON, Shalhav AL, Zorn KC. Use of novel hemostatic agents in robotic laparoscopic partial nephrectomy. Can Urol Assoc J. 2009;3(4):324–30.