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PEG-Based Sealants — CoSeal and Related Products

PEG-containing sealants are not one interchangeable product class. Their chemistry, approved tissues, swelling, application and contraindications differ. CoSeal forms a synthetic mechanical barrier; products combining PEG with a biologic protein have different source and allergy considerations.[1][2][3]

Product Distinctions​

ProductRelevant distinction (manufacturer labeling)
CoSeal (Baxter)Two synthetic PEGs; US indication is adjunctive hemostasis by mechanically sealing leakage in vascular reconstructions; no known contraindications listed[2][5]
DuraSeal Dural Sealant System (Integra)PEG hydrogel for cranial dural repair, adjunct to sutured repair with autologous duraplasty; swelling up to 50% linear; not for confined bony structures with nerves; absorbed in about 4–8 weeks[6]
Progel Pleural Air Leak Sealant (BD)PEG plus human serum albumin; visceral pleura after lung resection only; contraindicated with HSA or component allergy, insufficient renal capacity to clear the PEG load, or application to mainstem or lobar bronchial defects (including pneumonectomy, sleeve resection or bronchoplasty)[3]
Progel Platinum (BD)PEG plus recombinant human albumin (rice-derived); BD describes a European visceral-pleural air-leak indication (US FDA approval applies to Progel PALS); rice/rHA or component allergy, insufficient renal capacity to clear the PEG load, and application to mainstem or lobar bronchial defects (including pneumonectomy, sleeve resection or bronchoplasty) are contraindications[4]

CoSeal contains no thrombin. Its hemostatic effect is mechanical sealing, and it does not replace sutures, staples or vascular repair.[2] Chemistry, approved tissue and precautions differ between products. Progel is restricted to visceral pleura and is not a GU sealant.

Composition and Mechanism​

  • In the cited Baxter IFU, both PEG powders are supplied in one syringe, with two liquid-component syringes. Transfer one liquid to the powder syringe and mix the syringes back and forth at least 20 times until the powder dissolves; use the prepared component within 2 hours and co-deliver it with the second liquid through the applicator.[2] The 2001 FDA SSED describes an earlier kit with separate powder syringes.[5]
  • The mixed PEGs form a hydrogel that adheres to tissue and synthetic graft and bonds to itself. The FDA summary reports gel formation within seconds and resorption over several weeks (in vitro gel time under 3 seconds; resorbed in under 30 days).[5]
  • DuraSeal degrades by hydrolysis of ester bonds; the degradation products are excreted. Its FDA summary reports up to 200% volumetric swelling.[6]

Implications for GU Reconstruction​

Urinary leak prevention is outside the vascular, lung and dural sealing approvals. Urinary-tract anastomotic or suture-line reinforcement (ureteroenteric anastomosis, cystotomy, fistula repair) with CoSeal is off-label under its vascular indication[2]; a porcine partial-nephrectomy study found weaker renal-parenchymal adherence than Tisseel and small retrograde-study urinary leaks in all three acute CoSeal animals at postoperative day 3 versus none in the fibrin-glue cohort.[8] Use it only with a procedure-specific rationale, as an adjunct to a sound, tension-free tissue repair. Swelling is the main concern near the ureter, urethra and pelvic nerves and in the presacral space, so keep the layer thin and avoid a compressive mass. In a porcine percutaneous nephrostomy model, direct injection of 2 mL of CoSeal into the collecting system obstructed 3 of 6 treated kidneys, each with a retroperitoneal urinoma at five days.[7]

For patients who decline blood or animal-derived components, confirm the exact product composition and the individual patient's choices. CoSeal is fully synthetic.[2] Progel PALS contains human serum albumin.[3] Progel Platinum contains rice-derived recombinant human albumin with no human or animal source, according to BD.[4]

CoSeal Handling and Safety (manufacturer IFU)​

  • Aspirate excess blood and blot or air-dry the surface first.[2]
  • Apply a thin, continuous layer, about 1 mm (1 mL per 10 cm²), using the minimum needed to seal. With the supplied standard applicator, hold the tip about 3 cm from the site without touching tissue or exceeding 6 cm; with the optional CoSeal Spray Set, hold the spray tip about 10 cm away and overlap passes slightly.[2]
  • CoSeal swells up to four times its volume within 24 hours, with further swelling as the gel resorbs. Consider the maximum swell volume and its effect on compression-sensitive structures; use a thin layer in compression-sensitive cavities.
  • Wait at least 60 seconds before restoring circulation, irrigating, blotting or touching the sealant. If it stays watery and does not gel in about 30 seconds, flush with saline and aspirate.
  • Do not inject into vessels. Do not use as an adhesive, even temporarily, for any object; do not cover devices that will need removal; do not lay objects on it until it is non-tacky.
  • Pressurized-gas spray systems carry risks of air embolism, tissue rupture and gas entrapment; follow the applicator instructions.
  • Safety and performance are not established in children or pregnant women. In CoSeal's vascular clinical investigations, 2–16 mL per patient was used to seal a typical vessel; safety above 16 mL has not been evaluated.[2] Animal testing showed mild skin sensitization.
  • The IFU lists no known contraindications.
  • In a randomized peripheral-vascular-graft trial (148 patients, 74 per arm), the primary site-level endpoint of complete sealing within 10 minutes occurred at 117/136 CoSeal-treated sites (86%) and 108/128 gelatin-sponge/thrombin sites (84%).[5] At the patient level, 60/74 (81%) versus 58/74 (78%) had complete sealing within 10 minutes; immediate sealing occurred in 24/74 (32%) versus 12/74 (16%).[2][5]

Practical Selection​

Choose a sealant for a defined tissue and purpose, using its current instructions and the evidence for the actual operation.

See Also​

References​

1. Spotnitz WD, Burks S. Hemostats, sealants, and adhesives: components of the surgical toolbox. Transfusion. 2008;48(7):1502–16. doi:10.1111/j.1537-2995.2008.01703.x

2. Baxter. CoSeal Surgical Sealant: indication and important risk information. Instructions for Use (Rx only): indications, warnings, precautions and application. Manufacturer IFU.

3. BD. Progel Pleural Air Leak Sealant: composition, indication and contraindications. Manufacturer information.

4. BD. Progel Platinum Surgical Sealant: PEG and recombinant human albumin formulation, indication and contraindications. Manufacturer information.

5. US Food and Drug Administration. CoSeal Surgical Sealant: Summary of Safety and Effectiveness Data (P010022, approved December 14, 2001; Baxter supplement P030039). FDA SSED.

6. US Food and Drug Administration. DuraSeal Dural Sealant System: Summary of Safety and Effectiveness Data (P040034). FDA SSED.

7. Kim IY, Eichel L, Edwards R, et al. "Effects of commonly used hemostatic agents on the porcine collecting system." J Endourol. 2007;21(6):652–654. doi:10.1089/end.2007.9960

8. Bernie JE, Ng J, Bargman V, Gardner T, Cheng L, Sundaram CP. "Evaluation of hydrogel tissue sealant in porcine laparoscopic partial-nephrectomy model." J Endourol. 2005;19(9):1122–1126. doi:10.1089/end.2005.19.1122