Haemostatic action of a topical foam-based patch (VELSEAL-T) in haemophiliac patients with external bleeding

Anupam Dutta; Taniya Sarkar Dutta; Anup Kumar Das; Pranoy Dey

doi:10.17225/jhp00160

Abstract

Abstract Introduction

Haemophilia is an X-linked congenital bleeding disorder due to deficiency of coagulation factor VIII (in haemophilia A) or factor IX (in haemophilia B) caused by mutations of the respective clotting factor genes. Treatment involves the administration of an appropriate dose of factor concentrate, as soon as possible, in the event of any bleeding episode. In low-resource settings, such as Northeast India, where factor concentrates are not widely available, people with haemophilia (PwH) may bleed profusely even from trivial external injuries, warranting transfusion of blood or blood products. We previously reported on the use of a low cost, foam-based haemostatic patch to treat an external bleed in a single patient. In this study, we investigated its use to treat a range of external injuries in PwH presenting at Assam Medical College and Hospital.

Method

Over 24 months, eligible PwH with external injuries attending our haemophilia clinic were treated with a topical haemostatic patch (VELSEAL-T) at the target bleeding site. The time to cessation of bleeding was recorded and the wound sites evaluated after haemostasis to monitor efficacy and safety.

Results

Out of 72 individuals with bleeding disorders who volunteered to participate, 59 cases of external bleeding in 48 PwH were eligible for inclusion in the study. Nine (15.3%) had aberration wounds, 24 (40.7%) cut wounds, 21 (35.6%) tooth and/or gum bleeding and five (8.4%) bleeding from puncture wounds. The average time required for achievement of haemostasis was 9.9 (±4.7) minutes. Aberration wounds required the least amount of time for haemostasis at 7.3 (±4.4) minutes. Cut wounds required a mean time of 8.5 (±2.9) minutes; puncture wounds required 9.0 (±3.1) minutes; gum bleeding required the longest time to achieve haemostasis with a mean of 12.7 (±5.6) minutes.

Conclusion

The use of this topical haemostatic patch has been shown to be beneficial in the treatment of external injuries in PwH, and provides a good treatment option in resource-constrained areas. A larger controlled study would be helpful to further investigate its efficacy and safety.

Article

View Full Article

References

1. Sachdeva A, Gunasekaran V, Ramya HN, et al. Consensus statement of the Indian Academy of Pediatrics in diagnosis and management of hemophilia. Indian Pediatr 2018; 55: 582–90.
2. Gupta H, Dutta UP, Sengupta PP. The socioeconomic dimensions for the management of haemophilia in India: an empirical study. J Health Manag 2018; 20(1): 38–45. doi: https://doi.org/10.1177/097206341774699.
3. Dutta A, Dutta TS, Kar S, Kakati S, Dowerah P. Study on clinical presentation of factor deficient patients presenting to a tertiary care centre of North East India. Journal of Medical Science and Clinical Research 2016; 4(7): 11533–38. doi: https://doi.org/10.18535/jmscr/v4i7.57.
4. Dutta A, Dutta TS, Dey P. Clinical profile of haemophilia patients of Upper Assam – a hospital-based study. J Evol Med Dent Sci 2017;6(37):2990–93. doi: https://doi.org/10.14260/Jemds/2017/645.
5. Rodriguez-Merchan EC. Local fibrin glue and chitosan-based dressings in haemophilia surgery. Blood Coagul Fibrinolysis 2012; 23(6): 473–6. doi: https://doi.org/10.1097/MBC.0b013e3283555379.
6. Misgav M, Kenet G, Martinowitz U. Chitosan-based dressing for the treatment of external/accessible bleedings in children with bleeding tendency. J Pediatr Hematol Oncol 2014;36(2):140–2. doi: https://doi.org/10.1097/MPH.0b013e31828ac8b6.
7. Dutta A, Das AK. Haemostasis action of VELSEAL-T in a haemophilia A patient with external bleeding. J Haem Pract 2018; 5(1): 4–7. doi: https://doi.org/10.17225/jhp00105.
8. Forrest RD. Early history of wound treatment. J R Soc Med 1982; 75: 198–205.
9. Lawrence JC. What materials for dressings? Injury 1982; 13: 500–12. doi: https://doi.org/10.1016/0020-1383(82)90166-8.
10. Piskozub ZT. The efficiency of wound dressing materials as a barrier to secondary bacterial contamination. Br J Plast Surg 1968; 21(4): 387–401. doi: https://doi.org/10.1016/s0007-1226(68)80069-4.
11. Thomas S, Dawes C, Hay NP. Wound dressing materials—testing and control. Pharm J 1982; 228: 576–8.
12. Seaman S. Dressing selection in chronic wound management. J Am Podiatr Med Assoc 2002; 92(1): 24–33. doi: https://doi.org/10.7547/87507315-92-1-24.
13. Sood A, Granick MS, Tomaselli NL. Wound dressings and comparative effectiveness data. Adv Wound Care (New Rochelle) 2014; 3(8): 511–29. doi: https://doi.org/10.1089/wound.2012.0401.
14. Robinson BJ. The use of a hydrofibre dressing in wound management. J Wound Care 2000; 9(1): 32–4. doi: https://doi.org/10.12968/jowc.2000.9.1.25941.
15. Thorn RM, Austin AJ, Greenman J, Wilkins JP, Davis PJ. In vitro comparison of antimicrobial activity of iodine and silver dressings against biofilms. J Wound Care 2009; 18(8): 343–6. doi: https://doi.org/10.12968/jowc.2009.18.8.43635.
16. Spangler D, Rothenburger S, Nguyen K, et al. In vitro antimicrobial activity of oxidized regenerated cellulose against antibiotic resistant microorganisms. Surg Infect (Larchmt) 2003; 4(3): 255–62. doi: https://doi.org/10.1089/109629603322419599.
17. Hofman D, Wilson J, Poore S, Cherry G, Ryan T. Can Traumacel be used in the treatment of chronic wounds? J Wound Care 2000; 9(8): 393–6. doi: https://doi.org/10.12968/jowc.2000.9.8.26280.
18. Seyednejad H, Imani M, Jamieson T, Seifalian AM. Topical haemostatic agents. Br J Surg 2008; 95(10): 1197–225. doi: https://doi.org/10.1002/bjs.6357.
19. Hino M, Ishiko O, Honda KI, et al. Transmission of symptomatic parvovirus B19 infection by fibrin sealant used during surgery. Br J Haematol 2000; 108(1): 194–5. doi: https://doi.org/10.1046/j.1365-2141.2000.01818.x.
20. Pope M, Johnston KW. Anaphylaxis after thrombin injection of a femoral pseudoaneurysm: recommendations for prevention. J Vasc Surg 2000; 32(1): 190–1. doi: https://doi.org/101067/mva.2000.106498.
21. Tadokoro K, Ohtoshi T, Takafuji S, et al. Topical thrombin-induced IgE-mediated anaphylaxis: RAST analysis and skin test studies. J Allergy Clin Immunol 1991; 88(4): 620–9. doi: https://doi.org/10.1016/0091-6749(91)90156-i.
22. Wai Y, Tsui V, Peng Z, Richardson R, Oreopoulos D, Tarlo SM. Anaphylaxis from topical bovine thrombin (Thrombostat) during haemodialysis and evaluation of sensitization among a dialysis population. Clin Exp Allerg 2003; 33(12): 1730–4. doi: https://doi.org/10.1111/j.1365-2222-2003.01806.x.
23. Schuhmacher C, Pratschke J, Weiss S, et al. Safety and effectiveness of a synthetic hemostatic patch for intraoperative soft tissue bleeding. Med Devices (Auckl) 2015; 8: 167–74. doi: https://doi.org/10.2147/MDER.S79556.
24. Glineur D, Hendrikx M, Krievins D, et al. A randomized, controlled trial of Veriset™ hemostatic patch in halting cardiovascular bleeding. Med Devices (Auckl) 2018; 11: 65–75. doi: https://doi.org/10.2147/MDER.S145651.
25. Kranokpiraksa P, Pavcnik D, Kakizawa H, et al. Hemostatic efficacy of chitosan-based bandage for closure of percutaneous arterial access sites: An experimental study in heparinised sheep model. Radiol Oncol 2010; 44(2): 86–91. doi: https://doi.org/10.2478/v10019-010-0021-0.
26. Binet Q, Lambert C, Sacré L, Eeckhoudt S, Hermans C. Successful management of acquired hemophilia A associated with bullous pemphigoid: a case report and review of the literature. Case Rep Hematol 2017; 2017: 2057019. doi: https://doi.org/10.1155/2017/2057019.

PDF Download

Download PDF

Open in full-page viewer

Authors

Anupam Dutta

dranupamdutta80@gmail.com
Taniya Sarkar Dutta
Anup Kumar Das

Professor, Department of Medicine, Assam Medical College and Hospital, Dibrugarh, India
Pranoy Dey

Professor, Department of Paediatrics, Assam Medical College and Hospital, Dibrugarh, India