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TachoSil and Evarrest — Fibrin Sealant Patches

These patches combine human fibrinogen and thrombin with an absorbable carrier, but their carriers and indications differ. The fibrin layer adheres to the application surface.[1][2][6]

Composition and US Indications​

ProductCarrier and identificationUS labeled role
TachoSilEquine collagen sponge; yellow active side, off-white inactive side; Corza MedicalAdjunct to hemostasis with manual compression in adults and children aged at least one month in cardiovascular and hepatic surgery when suture, ligature or cautery is ineffective or impractical. Use elsewhere, including urologic surgery, is off-label in the US
EvarrestOxidized regenerated cellulose plus polyglactin 910 fibers, not collagen; powdery active side and embossed inactive side; EthiconAdjunct to surgical hemostasis with manual compression in adults when conventional techniques are ineffective or impractical; pediatric safety and effectiveness are not established

Both contain human plasma-derived proteins. TachoSil contains approximately 5.5 mg/cm² fibrinogen and 2 units/cm² thrombin.[2][6]

The EU authorization is broader: supportive treatment in surgery to improve hemostasis, promote tissue sealing and provide suture support in vascular surgery where standard techniques are insufficient (adults and children from 1 month), plus dural sealing in adult neurosurgery.[7] Tunical coverage and urinary-tract sealing must be considered separately from these US hemostatic indications. Neither product replaces mechanical repair of major arterial or venous defects.

GU Reconstruction Applications​

1. Peyronie's disease — tunical defect sealing​

TachoSil tunical coverage is outside its US hemostasis indications.[6] In men with stable Peyronie's disease and preserved erectile function, fibrin-coated collagen fleece has been used to seal a concave-side tunical defect without suture fixation after partial plaque excision.[3] After IPP placement for complex Peyronie's disease, collagen fleece has been used over a relaxing tunical incision for residual curvature; a separate retrospective implant cohort used Evarrest and other hemostatic patches.[4][5]

  • Hatzichristodoulou sealing technique: 319 of 367 operated patients returned for long-term assessment; 93.7% immediate and 91.2% long-term complete straightness at median 47.2 months.[3] Erectile function worsened in 15.7%.[3]
  • PICS technique (Penile Implant with Collagen Sealing). TachoSil is applied over the tunical defect after IPP insertion in severe Peyronie's; 84% complete straightening in a retrospective multicenter series of 37 patients.[4] Early complications occurred in 24%; one acute implant infection required explantation[4]
  • Graft selection and operative limitation. The EAU weakly recommends tunical lengthening for Peyronie's disease with normal erectile function and inadequate penile length, severe curvature, or complex deformity. Graft selection follows surgeon and patient preference because no graft has proven superior; residual deformity cannot be assessed perioperatively after TachoSil fleece grafting.[9]
  • See Peyronie's — plaque incision/grafting and Peyronie's — prosthesis with straightening

2. Partial nephrectomy and other GU sealing uses​

In laparoscopic partial nephrectomy for pT1aN0M0 renal-cell carcinoma, a single-institution retrospective comparison (n=113) found post-operative pseudoaneurysm requiring embolization in 11/81 conventional-suture patients versus 0/32 patients whose renorrhaphy bound a TachoSil patch into the closure.[8] This is an off-label technique. Across 15 partial-nephrectomy studies of mixed topical hemostatic agents (two randomized, 13 observational; n=3,408), a 2026 meta-analysis found no statistically significant difference for transfusion (RR 0.96, 95% CI 0.59–1.57), hemorrhagic complications (RR 0.73, 0.40–1.35), or urinary leakage (RR 1.36, 0.56–3.28) when an agent was added to renorrhaphy.[10]

Parenchymal or collecting-system reinforcement and urinary-diversion applications have been described. Farrell 2019 studied Peyronie's surgery with an implant: 18 patients received mixed hemostatic patches (10 Evarrest, 6 Nu-Knit and 2 TachoSil), compared retrospectively with 15 pericardium recipients. Median follow-up was 6.6 months for the mixed-patch group versus 34.6 months for the pericardium group.[5]

For the operative choice between tunical grafting and implant-associated straightening, use the procedure pages linked below.

Efficacy Evidence​

The US label rests on randomized comparisons against standard hemostatic care. In cardiovascular surgery, 44/59 TachoSil patients (75%) versus 20/60 patients (33%) treated with hemostatic fleece without active coagulation agents achieved hemostasis within three minutes.[6] In hepatic surgery, 92/114 (81%) versus 55/110 (50%) achieved the same endpoint against oxidized-cellulose fleece.[6] In a separate randomized trial of open abdominal, pelvic, retroperitoneal, and noncardiac thoracic surgery, Evarrest achieved hemostasis at four minutes without rebleeding through fascial closure in 59/60 patients versus 16/30 given oxidized regenerated cellulose.[2] A systematic review also reports randomized data in liver, thoracic and urologic surgery.[1] In an open, multicenter randomized trial of 185 patients undergoing nephron-sparing surgery for small, superficial kidney tumors, mean intraoperative time to hemostasis was 5.3 minutes with TachoSil versus 9.5 minutes with standard suturing; hemostasis within 10 minutes occurred in 92% versus 67%.[11]

Application and Safety​

Follow the actual product instructions; do not use a generic patch recipe. The US labels cap TachoSil use at 10 patches of 9.5 × 4.8 cm or 14 patches of 4.8 × 4.8 cm, and Evarrest use at eight patches of 5.1 × 10.2 cm.[2][6]

  • TachoSil: remove contaminating fluids and disinfectants. It may be applied wet or dry. If premoistening is chosen, use 0.9% saline and apply immediately; an oozing surface needs no premoistening. Apply the yellow side with at least three minutes of gentle pressure using moistened gloves or a pad. Choose a patch that extends 1–2 cm beyond the wound margin and overlap multiple patches by at least 1 cm. Alcohol, iodine and heavy-metal residues denature the proteins, so irrigate them away first.[6]
  • Evarrest: Keep the patch dry before application. Remove excess blood or fluid to visualize the bleeding site; do not apply to a nonvisualized surface. Place the active surface on the bleeding site with 1–2 cm of overlap and apply even, continuous manual compression over the entire patch, including the overlap, for three minutes.[2] Its label limits minimally invasive use when manual compression is difficult.[2]
  • TachoSil: Leave an adherent patch in place; if placement is unsatisfactory or bleeding persists, repeat application without removing the applied patch. Remove unattached pieces to limit dislodgement; the August 2025 US label strengthened this precaution.[6] Evarrest: Remove and replace a poorly positioned, folded or incompletely adherent patch. If bleeding persists during or after three minutes of compression, remove the used patch and apply a new one; if the bleeding site is incompletely covered, add a patch with 1–2 cm overlap.[2]
  • Do not apply intravascularly or substitute for repair of major arterial or venous bleeding. Avoid use in infected or contaminated sites according to labeling. For TachoSil, avoid packing cavities or closed spaces because of tissue compression; gastrointestinal obstruction from adhesions near bowel has been reported. For Evarrest, avoid bony foramina and confined bone spaces where swelling may compress nerves or vessels; inadvertent adhesions can occur.[2][6]
  • Check component allergy: TachoSil is contraindicated with horse-protein or human-blood-product hypersensitivity; Evarrest is contraindicated with anaphylactic or severe systemic reactions to human blood products. Both retain a residual infectious-agent transmission risk despite processing.[2][6]

A patch may provide local hemostasis or coverage in a selected operation.

See Also​

References​

1. Rickenbacher A, Breitenstein S, Lesurtel M, Frilling A. Efficacy of TachoSil a fibrin-based haemostat in different fields of surgery — a systematic review. Expert Opin Biol Ther. 2009;9(7):897–907. doi:10.1517/14712590903029172

2. Ethicon. Evarrest Fibrin Sealant Patch: US prescribing information. Revised September 2024. Label.

3. Hatzichristodoulou G, Fiechtner S, Pyrgidis N, et al. Suture-free sealing of tunical defect with collagen fleece after partial plaque excision in 319 consecutive patients with Peyronie's disease: the sealing technique. J Urol. 2021;206(5):1276–1282. doi:10.1097/JU.0000000000001933

4. Falcone M, Preto M, Peretti F, et al. The use of collagen fleece to correct residual curvature during inflatable penile prosthesis implantation (PICS technique) in patients with complex Peyronie disease: a multicenter study. J Sex Med. 2023;20(2):229–235. doi:10.1093/jsxmed/qdac003

5. Farrell MR, Abdelsayed GA, Ziegelmann MJ, Levine LA. A comparison of hemostatic patches versus pericardium allograft for the treatment of complex Peyronie's disease with penile prosthesis and plaque incision. Urology. 2019;129:113–118. doi:10.1016/j.urology.2019.03.008

6. Corza Medical. TachoSil Fibrin Sealant Patch: US prescribing information. Revised August 2025. Label.

7. European Medicines Agency. TachoSil: EPAR summary and authorized indications. EMA.

8. Shigeta K, Matsumoto K, Abe T, et al. The efficacy of the TachoSil binding suturing technique in laparoscopic partial nephrectomy to prevent the development of pseudoaneurysm. Asian J Surg. 2020;43(6):668-675. doi:10.1016/j.asjsur.2019.09.002

9. European Association of Urology. EAU Guidelines on Sexual and Reproductive Health. 2026 ed. §8.2.3.b.2, Penile Curvature: Tunical lengthening procedures. EAU Guidelines Office, Arnhem, the Netherlands. Guideline.

10. Shiomi da Cruz JA, De Souza Almeida A, Terada BD, et al. "Adjunctive topical hemostatic agents combined with renorrhaphy versus renorrhaphy alone during partial nephrectomy: a systematic review and meta-analysis." World J Urol. 2026;44(1):592. doi:10.1007/s00345-026-06679-5

11. Siemer S, Lahme S, Altziebler S, et al. "Efficacy and safety of TachoSil as haemostatic treatment versus standard suturing in kidney tumour resection: a randomised prospective study." Eur Urol. 2007;52(4):1156–1163. doi:10.1016/j.eururo.2007.04.027