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. 2022 Feb 11;9:805053. doi: 10.3389/fbioe.2021.805053

TABLE 3.

Characteristics of BC and BC composites used in wound care—results of clinical trials.

Material Material characteristics BC Manufacturer Study design Studied organism Wound Type Wound evaluation (changes assessed in wounds) Clinical outcome References
Wound dressings
 BC tensile strength of 400.60 ± 51.19; elongation at break (%) of 9.56 ± 5.32 Gluconacetobacter xylinum (strain not provided) in vivo ICR male mice with an average body weight of 25–30 g incised wound • ability to heal wounds
• histopathological examination
• faster and better wound healing (wound area treated with BC and BC-Vac was .56 and .5 mm, respectively, and controls were approximately 3 mm)
• a wound covered with BC or BC-Vac showed better fluid retention compared to controls
• easier removal of BC and BC-Vac dressing from the wound compared to control
• more significant activity of fibroblasts and epithelialization
Qiu et al. (2016)
 BC-vaccarin composite (BC-Vac) tensile strength of 459.73 ± 48.21 and elongation at break (%) of 19.36 ± 10.45
 BC ND Zoogloea sp;
POLISA, Biopolymers for Health, a startup hosted by the Federal Rural University of Pernambuco (UFRPE)
(BC obtained from sugar cane)
clinical trial 24 patients aged around 42 preserve the nail bed after avulsion • macroscopic wound observation
• patient’s satisfaction
• pain intensity
• increased patients’ satisfaction
• reduced pain
• faster wound healing process
• protection against infections
• good wound coverage
• protection against mechanical injury
Oliveira et al. (2020)
 BC ND ND clinical trial 24 patients 49–90 years old ischemic wounds after lower limb revascularization • macroscopic wound observation • faster wound healing process Maia et al. (2019)
Burn wound dressing
 BC composite with silver sulfadiazine nanoparticles (BC—SSD membrane) ND BC membranes were purchased from Hainan Yida Food Co. Ltd (China). in vivo Wistar rats (weight ∼ 250 g) partial-thickness skin wounds (20 × 20 mm) • macroscopic examination of the wound surface
• histopathological examination
• microbiological examination of the wound surface
• no infection reduction in the number of bacteria on the wound surface
faster wound healing (wound healing 92.35% for BC-SSD and 78.83% for control)
sooner onset of re-epithelization compared to the control wound
Wen et al. (2015)
 BC the crystallinity of BC in AgNP-BC is about 83.68% Hainan Yida Food
Co. Ltd (China)
in vivo Wistar rats (half male and half female) weight ∼250 g deep partial-thickness
2nd-degree burn wound (80 °C) (20 mm–20 mm)
• macroscopic examination of the wound surface
• histopathological examination
• less inflammation
• faster wound healing
• after 10 days, the wound defect filling was 62.13% (for AgNP-BC), 42.82% (for BC), 27.94% (for controls) (p < .05)
• after 21 days, the wound defect filling was 99.3% (AgNP-BC), ∼ 82.37% (BC), 68.36% (control) (p < .05)
• after 28 days, the wound defect filling was 100% (for AgNP-BC), about 96.42% (for BC), 81.58% (for control)
• supporting the wound healing process
• fewer bacteria on the wound surface (less bacterial multiplication) after 4 days 40.00 × 103 CFU cm−2 (AgNP-BC), 128.13 × 103 CFU cm−2 BC and 161.48 × 103 CFU cm-2 (control)
• extension of epidermal tissue deeper into the wound site (the thickness of the regenerated fresh epidermis and dermis was 111 and 855 μm, respectively (AgNP-BC, 74 and 619 μm (BC), 57 and 473 μm (control))
Wu et al. (2014)
AgNP-BC composite
 Composites of BC with Ag nanoparticles (BC-PDAg) water vapour transmission rate arround 500 g/m2/day no influence of Ag ions on BC-PDAg composite permeability) Acetobacter xylinum (NCIM 2526) in vivo female albino Wistar rats third degree burn wounds • macroscopic examination of the wound surface
• histopathological examination
• quantitative real time polymerase chain reaction (qRT-PCR)—expression level testing for the following genes: IL-10, VEGF-A, VEGF-B and bFGF, IL-1 α, IL-3, TGF-β3 and SMAD-3
• no allergic reactions
• less inflammation
• faster wound healing with no scar formation
• facilitated colagenisation and granulation tissue formation as well as re-epithelization
• on 20th day surface of healed wound was 94.35%, BC-PDAg 74.58% BC and 65.35% in control group
• complete wound healing without scar formation in 25th day (after BC-PDAg usage)
• fast wound healing rate of BC-PDAg treatment through the upregulation of IL-10, VEGF-A, VEGF-B and bFGF and suppression of IL-1 α and IL-3 transcripts. Further, TGF-β3 and SMAD-3 expression has proven the promotion of wound healing without scar formation.
Jiji et al. (2020)
 Composite of BC with polyhydroxyalkanoates (PHAs)
BC/P(3HB/4HB), BC/P(3HB/4HB)/actovegin, P(3HB/4HB)/BC/fibroblasts
Young's modulus of BC (47.60 ± 6.32 MPa),
BC/P(3HB/4HB) (65.08 ± 7.1 MPa),
Water vapor transmission rate of BC, g/m2/d 2655 ± 21 and BC/P(3HB/4HB)
(5014 ± 20)
Fracture strength [MPa] of BC (.11 ± .13) and BC/P(3HB/4H)
(.88 ± .08)
Komagataeibacter xylinus B-12068 in vivo female Wistar rats third-degree skin burns • macroscopic examination of the wound surface
• histopathological examination
• biochemical and molecular methods of detecting factors of angiogenesis,
• inflammation, type I collagen, and keratin 10 and 14
• faster and more effective wound healing
• on 14th day wound surface reduced to 30,6% and 7.3% of initial wound surface after administration of BC/P(3HB/4HB)/Actovegin and BC/P(3HB/4HB)/fibroblasts
• average healing rate for BC/P(3HB/4HB)/Actovegin and BC/P(3HB/4HB)/fibroblasts was estimated as .19 cm2/day and .4 cm2/day in control
• more effective epidermization after treatment with BC/P(3HB/4HB)/Actovegin and BC/P(3HB/4HB)/fibroblasts
Volova et al. (2019)
 cellulose-g-poly (acrylic acid) hydrogels highly porous (80.3 up to 255 μm) hydrogel with high swelling ratio ND in vivo female Sprague-Dawley rats partial-thickness skin burns • macroscopic examination of the wound surface
• histopathological examination
• no signs of local inflammatory responses
• faster wound healing process
• improved epithelialization and faster fibroblast proliferation
Pandey et al. (2017)
Chronic wound dressing
 BC ND Zooglea sp.; POLISA, Biopolymers for Health, a startup hosted by the
Federal Rural University of Pernambuco (UFRPE)
(BC obtained from sugar cane)
clinical trial 39 patients Chronic venous ulcers (CVU) • macroscopic examination of the wound surface
• dressing exchange frequency
• patient satisfaction
• ∼ 3 times lower frequency of dressing changes
• faster healing process
• no macerization
• epithelization of the edges of the wound
• good wound adherence
Silva et al. (2021)
25 patients • macroscopic examination of the wound surface
• patient satisfaction
• pain sensation reduction
• maintaining humidity
• absorption of excess exudate
• protection against infections
• protection against mechanical injury
Cavalcanti et al. (2017)
Wound dressing
 BC ND Zoogloea sp.; Laboratory of Biopolymers at the Experimental Station of Sugarcane, Federal Rural University of Pernambuco (BC obtained from sugar cane
Molasses)
phase II clinical trial 141 patients (children, adolescents and adults) postoperative wound of male urogenital organs • effectiveness and safety (irritation of the skin in the area of the dressing - feeling of warmth, itching, swelling, pain and congestion)
• patient satisfaction level
• the time of the dressing remaining on the wound
• healing time
• safe in wound healing (no complications such as ischemia, infections)
• easy to use (put on and take off the wound)
• long time of use without the need to replace
• removes exudate
• creates a moist environment
• protects against foreign substances
• supports tissue regeneration
Vilar et al. (2016)