Recombinant human thrombin: safety and immunogenicity in pediatric burn wound excision

Foster, Kevin N; Mullins, Robert F.; Greenhalgh, David G.; Gamelli, Richard L.; Glat, Paul M.; Lentz, Christopher W.; Kahn, S.; Brandigi, Claus; Fredlund, Paul; Alexander, W. Allan

doi:10.1016/j.jpedsurg.2011.05.022

Cited by 12 publications

(8 citation statements)

References 18 publications

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“…Fibrin sealant has been observed to aid clot formation thereby promoting hemostasis and reducing the chances of hematoma formation. However, Foster et al 24 and Han et al 21 reported 29.7 and 7.84% incidence of seroma and hematoma, respectively, in the fibrin sealant group. The sheet grafts applied to the wound bed in their study could have accounted for the formation of seroma and hematoma as drainage is limited in a sheet as compared with a meshed graft.…”

Section: Discussionmentioning

confidence: 93%

An Outcome Analysis of Fibrin Sealant versus Staples for Fixation of Split-Thickness Skin Grafts

Shuchi,

Gupta,

Sarabahi

2024

Indian J Plast Surg

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Background Skin grafting plays a vital role in post-burn and post-traumatic wound management. Split-thickness skin grafts (STSG) are traditionally fixed using staples or sutures, which have tedious application and their removal necessitates painkillers, medical equipment, and human intervention. As an alternative, fibrin sealant is a biological tissue adhesive, composed of thrombin, calcium, and fibrinogen. Fibrin sealant promotes hemostasis and acts as a biological adherent. Objective The aim of this study was to evaluate the outcomes (graft take, wound healing and complications) of fibrin sealant and staples for STSG fixation. Methods It is a randomized controlled trial on 40 patients with wounds of minimum 400 cm2. Wound area was divided into equal halves and randomly allocated to the study group or control group. In the study group, 4 mL per 200 cm2 of fibrin sealant was sprayed followed by STSG application. In the control group, STSG was fixed with only skin staples. Evaluation was done on postoperative days 3, 5, 15, and 30 for graft take, hematoma/seroma, infection, and complete wound healing. Results The mean graft take was significantly higher (p-value < 0.05) in the study group than in the control group (91 vs. 89%). No seroma or hematoma formation was seen in either group. Complete wound healing was seen in more patients in the study group, but the difference was statistically insignificant. Conclusion Fibrin sealant is an excellent alternative to staples for skin grafting, with the advantage of better graft take and being free of pain that is incurred during staple removal.

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Section: Discussionmentioning

confidence: 93%

An Outcome Analysis of Fibrin Sealant versus Staples for Fixation of Split-Thickness Skin Grafts

Shuchi,

Gupta,

Sarabahi

2024

Indian J Plast Surg

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“…Ten clinical trials of rThrombin were conducted in adult and pediatric patients in the United States between December 30, 2003, and July 10, 2010 (Table ) . Details regarding each of these studies have been reported previously . Recombinant human thrombin was administered in a range of surgical settings to patients of differing ages (including pediatric patients).…”

Section: Methodsmentioning

confidence: 99%

“…In all studies, eligible patients had no known hypersensitivity to thrombin. Additional inclusion and exclusion criteria differed by study and have been previously reported . Four studies included a placebo group, and one study included a bovine thrombin treatment group.…”

Section: Methodsmentioning

confidence: 99%

Safety and Immunogenicity of Recombinant Human Thrombin: A Pooled Analysis of Results from 10 Clinical Trials

et al. 2012

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Recombinant human thrombin was well tolerated, and adverse events were consistent with those reported in the postoperative setting in the surgical populations studied. Approximately 1 month after treatment, less than 1% of the patients had developed antibodies to the rThrombin product, and these antibodies did not neutralize the activity of native human thrombin. These results support the safety of rThrombin when used as a topical aid to hemostasis in numerous surgical settings and for patients of differing ages.

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“…High prothrombotic activity, without causing systemic thrombosis [17] Burn treatment Thrombin Solution High wound healing efficacy after skin removal [91] Burn treatment Recombinant human thrombin (rThrombin) Solution Good tolerance in pediatric patients undergoing burn wound excision and skin grafting, without formation of anti-rThrombin antibodies [93] Burn treatment Bovine thrombin Epinephrine-bovine thrombin-soaked pads Reducing blood loss in excision and grafting procedures [98,99] Wound management Thrombin Thrombin-conjugated maghemite (𝛾-Fe 2 O 3 ) nanoparticles…”

Section: Thrombin Used For Hemostasismentioning

confidence: 99%

Thrombin and Thrombin‐Incorporated Biomaterials for Disease Treatments

Zhang,

Duan,

et al. 2023

Adv Healthcare Materials

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Thrombin, a coagulation‐inducing protease, has long been used in the hemostatic field. During the past decades, many other therapeutic uses of thrombin have been developed. For instance, burn treatment, pseudoaneurysm therapy, wound management, and tumor vascular infarction (or tumor vasculature blockade therapy) have all utilized the unique and powerful function of thrombin. Based on their therapeutic effects, many thrombin‐associated products have been certificated by the Food and Drug Administration, including bovine thrombin, human thrombin, recombinant thrombin, fibrin glue, etc. Besides, several thrombin‐based drugs are currently undergoing clinical trials. In this article, we summarize the therapeutic uses of thrombin (from the initial hemostasis to the latest cancer therapy), the commercially available drugs associated with thrombin, and the pros and cons of thrombin‐based therapeutics (e.g., adverse immune responses related to bovine thrombin, thromboinflammation, and vasculogenic “rebounds”). Further, we discuss the current challenges and possible future research directions of thrombin‐incorporated biomaterials and therapies. It is hoped that this review may provide a valuable reference for researchers in this field and help them to design safer and more effective thrombin‐based drugs for fighting against various intractable diseases.This article is protected by copyright. All rights reserved

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Recombinant human thrombin: safety and immunogenicity in pediatric burn wound excision

Cited by 12 publications

References 18 publications

An Outcome Analysis of Fibrin Sealant versus Staples for Fixation of Split-Thickness Skin Grafts

An Outcome Analysis of Fibrin Sealant versus Staples for Fixation of Split-Thickness Skin Grafts

Safety and Immunogenicity of Recombinant Human Thrombin: A Pooled Analysis of Results from 10 Clinical Trials

Thrombin and Thrombin‐Incorporated Biomaterials for Disease Treatments

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