Table 3.
Clinical studies on the role of bFGF in cutaneous wound management and scar prevention
| Title | Type of study | Method | Number of subjects | Results |
|---|---|---|---|---|
| Akita et al. [19] | Randomized controlled trial (RCT) | Clinical assessment of postoperative color uniformity in split-thickness skin grafting | 40 | bFGF treatment contributed to a better color match with skin grafting postoperatively |
| Morimoto et al. [20] | RCT | Clinical evaluation of the safety and efficacy of collagen/gelatin scaffold impregnated with bFGF (7 or 14 μg/cm2) in the treatment of chronic skin ulcers after debridement | 17 | In 16 out of 17 patients, the wound bed improved 14 days after application without serious adverse reactions |
| Uchi et al. [21] | RCT | Clinical assessment of topical bFGF treatment of non-ischemic diabetic ulcers for 8 weeks, in a dose-dependent manner | 150 | bFGF accelerated wound healing in diabetic ulcers with 75% or greater reduction in the area of the wound |
| Akita et al. [22] | RCT | Clinical assessment of patients receiving topical bFGF or no bFGF; outcomes were compared for clinical scar extent, passive scar hardness, elasticity, and moisture analysis of the stratum corneum at 1 year after complete wound healing | 153 | Combined use of bFGF and artificial skin substitute led to improved wound quality (scars) and facilitated wound healing |
| Hayashida et al. [23] | RCT | Clinical evaluation of the effect of bFGF treatment in pediatric patients with deep second-degree burn wounds | 20 | Accelerated healing, reduced scarring, and improved color matching with normal skin compared with controls up to half a year postoperatively |
| Akita et al. [15] | Clinical study | Clinical assessment of sequential lower extremity reconstruction using an artificial dermis with or without bFGF administration, and secondary split-thickness skin grafting by measuring hardness using a durometer, and moisture parameters for at least 6 months after the final procedure and comparison with normal skin controls | 12 | bFGF-treated sequential artificial dermis and skin grafting demonstrated better scarring and well-organized stratum corneum after healing |
| Ono et al. [31] | Prospective clinical study | Investigation on bFGF injected into the dermis of wound margins in full-thickness wounds in patients postoperatively after resection of skin tumors | 230 | Significant reduction of hypertrophic scarring and widening of remnant scars without any serious side effects |
| Sugamata et al. [62] | Clinical study | Clinical assessment of combined artificial dermis and application of Fiblast® spray in 6 cases of traumatic fingertip amputation | 6 | The shapes of the fingertips were satisfactorily reconstructed in all patients |
| Matsumoto et al. [72] | Clinical study | Examination of the safety of bFGF-impregnated gelatin application for patients | 4 | The findings suggested that controlled-release bFGF using gelatin sheet is effective for promoting wound healing |
| Saijo et al. [82] | Case reports | Application of combined treatment of artificial dermis and bFGF to treat cranial bone-exposing wounds followed by free skin grafting | 2 | The formation of granulation tissue was promoted and acted as a wound bed for the subsequent skin grafting |
| Kurokawa et al. [83] | Case report | Topical application of bFGF to chronic leg ulcers at a dose of 30 μg/day for 3 months | 1 | The ulcer area was reduced by promoted angiogenesis, re-epithelization, granulation and scar formation |
| Asai et al. [84] | Case report | Topical application of a mixture of peripheral blood mononuclear cells (PBMC) and bFGF to diabetic foot ulcer | 1 | The ulcer was completely closed and no new ulceration recurred after 6 months follow-up |
| Ito et al. [85] | Case report | Combined application of bilayer artificial dermis graft and bFGF without secondary skin grafts or flaps to large soft tissue defect of the heel after a degloving injury | 1 | bFGF induced wound closure and successful reconstruction without sacrificing skin from donor sites |
| Akita et al. [86] | Case report | Simultaneous application of bFGF with regular surgical debridement and skin grafting was investigated for skin hardness by clinical examination and instrumental measurement | 1 | Wounds treated with bFGF produced scars that were significantly less hard 1 year after final wound closure |
| Muneuchi et al. [87] | Case reports | 0.1 mL of bFGF (Fiblast®) was injected into the sutured collagen layer of artificial dermis followed by daily injection of bFGF for 2 weeks, topical ointment with recombinant bFGF was then continued | 2 | The wound was completely epithelialized 10 weeks after injury with good sensory recovery |
| Yamaka et al. [88] | Case report | Topical application of rhbFGF 30 μg/daily in combination with prostaglandin E1 ointment applied directly to therapy-resistant chronic leg ulcers in scleroderma | 1 | The lesions were completely re-epithelialized within 20 days and the ulcers did not recur during the 20-month follow-up period |