Chronic venous ulcers: a review on treatment with fibrin sealant and prognostic advances using proteomic strategies

Abbade, Luciana Patrícia Fernandes; Júnior, Rui Seabra Ferreira; Santos, Lucilene Delazari dos; Barraviera, Benedito

doi:10.1590/1678-9199-jvatitd-2019-0101

Cited by 23 publications

(25 citation statements)

References 63 publications

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“…Such findings are in line with studies that used FBP for the same purpose, obtaining favorable results in tissue regeneration [ 12 , 46 ]. The proportion of its components and the sequence of manipulation is adjusted according to the purpose of its use, for example, in the repair of nerve injuries [ 47 ], bone [ 14 , 48 , 49 ], venous ulcers [ 50 , 51 ], and stem cells [ 46 , 52 , 53 ].…”

Section: Discussionmentioning

confidence: 99%

“…In addition, PBMT with Laserpulse Ibramed ® [ 69 ], GenDerm ® bovine bone membrane [ 70 ], and the biomaterial GenPhos XP ® [ 71 ] have been used clinically in several health areas, mainly in dentistry and regenerative medicine. The fibrin biopolymer is in phase II/III of clinical tests at the Brazilian Health Regulatory Agency (ANVISA) in the treatment of venous ulcers, and pre-clinical tests in several areas have demonstrated its translational potential [ 45 , 51 , 72 ].…”

Section: Discussionmentioning

confidence: 99%

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Photobiomodulation Therapy on the Guided Bone Regeneration Process in Defects Filled by Biphasic Calcium Phosphate Associated with Fibrin Biopolymer

et al. 2021

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The aim is to evaluate the effects of photobiomodulation therapy (PBMT) on the guided bone regeneration process (GBR) in defects in the calvaria of rats filled with biphasic calcium phosphate associated with fibrin biopolymer. Thirty male Wistar rats were randomly separated: BMG (n = 10), defects filled with biomaterial and covered by membrane; BFMG (n = 10), biomaterial and fibrin biopolymer covered by membrane; and BFMLG (n = 10), biomaterial and fibrin biopolymer covered by membrane and biostimulated with PBMT. The animals were euthanized at 14 and 42 days postoperatively. Microtomographically, in 42 days, there was more evident bone growth in the BFMLG, limited to the margins of the defect with permanence of the particles. Histomorphologically, an inflammatory infiltrate was observed, which regressed with the formation of mineralized bone tissue. In the quantification of bone tissue, all groups had a progressive increase in new bone tissue with a significant difference in which the BFMLG showed greater bone formation in both periods (10.12 ± 0.67 and 13.85 ± 0.54), followed by BFMG (7.35 ± 0.66 and 9.41 ± 0.84) and BMG (4.51 ± 0.44 and 7.11 ± 0.44). Picrosirius-red staining showed greater birefringence of collagen fibers in yellow-green color in the BFMLG, showing more advanced bone maturation. PBMT showed positive effects capable of improving and accelerating the guided bone regeneration process when associated with biphasic calcium phosphate and fibrin biopolymer.

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Section: Discussionmentioning

confidence: 99%

Section: Discussionmentioning

confidence: 99%

Photobiomodulation Therapy on the Guided Bone Regeneration Process in Defects Filled by Biphasic Calcium Phosphate Associated with Fibrin Biopolymer

et al. 2021

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“…The biggest challenges of our study were as follows: first, to prospect, produce, and develop a new toxin-based bioproduct within good laboratory practices, then convince the regulatory agency and the ethics committee to authorize the conduct of the clinical trial; and second, to convince patients to join the study. As most of the candidate molecules found in animal toxins are present in very low amounts, isolation and production was a major challenge, and was only possible due to the development of the technical methodologies for the isolation and purification of the components used, allowing for its future registration and commercial scaling ( 12 , 15 , 24 , 26 ).…”

Section: Discussionmentioning

confidence: 99%

“…Fibrin sealant plays an important role in hemostasis and the healing process, given that the network of fibrin and the matrix of proteins associated with it not only promotes angiogenesis, collagen synthesis, and wound contraction, but also contributes to accelerated re-epithelization (8)(9)(10). By remaining in the ulcer bed for at least four days and totally degrading within 10 days, fibrin sealant is an excellent scaffold for incorporating and facilitating cell growth and the release of growth factors and antibiotics (11,12).…”

Section: Introductionmentioning

confidence: 99%

Treatment of Chronic Venous Ulcers With Heterologous Fibrin Sealant: A Phase I/II Clinical Trial

et al. 2021

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BackgroundHeterologous fibrin sealant (HFS) consists of a fibrinogen-rich cryoprecipitate extracted from Bubalus bubalis buffalo blood and a thrombin-like enzyme purified from Crotalus durissus terrificus snake venom. This study evaluated the safety and immunogenicity of HFS, estimated the best dose, and assessed its preliminary efficacy in the treatment of chronic venous ulcers (CVU).MethodsA phase I/II non-randomized, single-arm clinical trial was performed on 31 participants, accounting for a total of 69 active CVUs. All ulcers were treated with HFS, essential fatty acid, and Unna boot for 12 weeks. The outcomes assessed were: (1) primary safety, immunogenicity analyses, and confirmation of the lowest safe dose; (2) secondary promising efficacy by analyzing the healing process. Immunogenicity was evaluated using the serum-neutralizing (IgM and IgG) and non-neutralizing (IgA and IgE) antibody techniques against the product. The immuno-detection of IgE class antibodies was assessed using dot-blot assay before and at the end of treatment. Positive samples on dot-blot assays were subsequently analyzed by western blotting to verify the results.ResultsNo severe systemic adverse events related to the use of HFS were observed. Local adverse events potentially related to treatment include ulcer pain (52%), peri-ulcer maceration (16%), peri-ulcer pruritus (12%), critical colonization (8%), peri-ulcer eczema (4%), the opening of new ulcers (4%), and increased ulcerated area 4%). Neutralizing and non-neutralizing antibodies did not show significant deviations at any of the evaluated time points. Blot assays showed that all patients presented negative immunological reactions, either before or after treatment, with the thrombin-like enzyme component. In addition, two participants showed a positive immunological reaction to the cryoprecipitate component, while another two were positive before and during treatment. Regarding the secondary outcomes of preliminary efficacy, a total healing and significant reduction of the area was observed in 47.5 and 22%, respectively. A qualitative improvement was observed in the wound beds of unhealed ulcers.ConclusionsThe investigational HFS bioproduct proved to be safe and non-immunogenic with a good preliminary efficacy for the treatment of CVU, according to the protocol and doses proposed. A multicentric phase III clinical trial will be necessary to verify these findings.

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“…More recently, a new heterologous fibrin sealant composed of fibrinogen-rich cryoprecipitate, extracted from Bubalus bubalis buffalo blood, and a thrombin-like enzyme, purified from the venom of Crotalus durissus terrificus, has been considered as a promising material in medicine and dentistry [ 32 , 33 , 34 , 35 , 36 ]. This biopolymer has biocompatibility (nontoxic), low-cost to produce in addition to hemostatic, sealant, adhesive, scaffold, and drug delivery properties [ 32 , 33 , 34 , 35 , 36 , 37 , 38 , 39 ]. In the presence of calcium, the thrombin-like enzyme acts on fibrinogen molecules, turning them into fibrin monomers, resulting in a stable clot [ 33 , 34 , 35 ].…”

Section: Introductionmentioning

confidence: 99%

Fibrin Biopolymer Incorporated with Antimicrobial Agents: A Proposal for Coating Denture Bases

et al. 2021

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The characteristics of the denture base surface, in combination with the oral environment, promote the colonization and development of Candida albicans biofilm, which is the main cause of denture stomatitis. This study evaluated the effectiveness of fibrin biopolymer with digluconate chlorhexidine or Punica granatum alcoholic extract to prevent C. albicans biofilm. Conventional heat polymerized and pre-polymerized poly(methyl methacrylate) (PMMA) circular specimens (10 × 2 mm) were fabricated (n = 504) and randomly divided into groups: no treatment (control—CT), fibrin biopolymer coating (FB), fibrin biopolymer with P. granatum (FBPg), or digluconate of chlorhexidine (FBCh) coating. The specimens were inoculated with C. albicans SC5314 (1 × 107 cells/mL) and incubated for 24, 48, and 72 h. Crystal violet and colony-forming unit assays were used to quantify the total biofilm biomass and biofilm-living cells. A qualitative analysis was performed using confocal laser scanning microscopy. Data obtained are expressed as means and standard deviations and were statistically analyzed using a three-way analysis of variance (α = 0.05). The FBPg and FBCh groups inhibited the growth of C. albicans biofilm in both PMMA materials analyzed, with FBCh performing better in all periods evaluated (p < 0.0001). The colony forming unit (CFU) assay showed that the FB group favored the C. albicans biofilm growth at 24 h and 48 h (p < 0.0001), with no differences with CT group at 72 h (p = 0.790). All groups showed an enhancement in biofilm development up to 72 h (p < 0.0001), except the FBCh group (p = 0.100). No statistical differences were found between the PMMA base materials (p > 0.050), except in the FB group (p < 0.0001). Fibrin biopolymer, albeit a scaffold for the growth of C. albicans, when combined with chlorhexidine digluconate or P. granatum, demonstrated excellent performance as a drug delivery system, preventing and controlling the formation of denture biofilm.

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Chronic venous ulcers: a review on treatment with fibrin sealant and prognostic advances using proteomic strategies

Cited by 23 publications

References 63 publications

Photobiomodulation Therapy on the Guided Bone Regeneration Process in Defects Filled by Biphasic Calcium Phosphate Associated with Fibrin Biopolymer

Photobiomodulation Therapy on the Guided Bone Regeneration Process in Defects Filled by Biphasic Calcium Phosphate Associated with Fibrin Biopolymer

Treatment of Chronic Venous Ulcers With Heterologous Fibrin Sealant: A Phase I/II Clinical Trial

Fibrin Biopolymer Incorporated with Antimicrobial Agents: A Proposal for Coating Denture Bases

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