Table 2.
Authors | Level of evidence | Patient clinical criteria | Study design | Outcome measures | Follow-up period | Outcomes |
---|---|---|---|---|---|---|
Pruksapong et al.37 | Level 2c | N = 25 Inclusion criteria: patients aged > 18 years with at least two keloid sites or one site ⩾ 10 cm in length and requiring revision/excision. Exclusion criteria: allergy to BXT-A/lidocaine, pregnancy/breast-feeding, previous BXT-A injection within the last 6 months, systemic medical conditions, anticoagulant/antiplatelet drugs. |
The toxin group was injected with a single intradermal BXT-A dose at 1.5 units/cm scar length 7 days after stitch removal. Control group received triamcinolone (10 mg/mL) at a dose dependent upon the wound size and was performed 7 days after stich removal, as well as after 1, 3 and 6 months. | Scars were assessed by two plastic surgeons using the VSS during the preoperative period, as well as during 1-, 3- and 6-month follow-ups. Pre- and postoperative photographs were also taken. |
Follow-up was performed at days 7 (initial injection) and 14, as well as at 1, 3 and 6 months. | VSS improvement was noted in both groups at 1-, 3- and 6-month follow-ups (P < 0.001). The toxin group VSS outcome was more favourable than the control group at months 1 and 3 (6.22 ± 1.72 vs. 5.89 ± 1.83, P = 0.347) in a non-statistically significant manner, whereas the control group fared better in the sixth follow-up month (5.33 ± 1.87 vs. 4.11 ± 1.96, P = 0.010). |
Wilson38 | Level 2d | N = 80 Patients with longstanding keloids (of at least 1 year) were excised in an extralesional manner with minimal undermining; age range of patients was 16–42 years (mean age = 24.7 years); the male:female ratio was 3:5. Regarding location, 26 were pre-sternal, 20 facial, 14 truncal, 12 earlobe and 8 upper limb keloids. |
A single dose of 5-fluorouracil (0.4 mL of 50 mg/mL solution was infiltrated per cm of wound tissue) was injected with BXT-A (20 IU of a 50 IU/mL solution) into the wound edge on postoperative day 9 in intradermal and subdermal planes. The total 5-fluorouracil dose was kept < 500 mg, while BXT-A was kept < 140 IU. |
Postoperative adverse events were noted via subjective patient reports. A subjective scoring technique was used to report patient improvements in cosmetic outcome. | All patients were reviewed once per month for 2 years, with the follow-up period in the range of 17–24 months (mean = 19.6 months). | In all cases, improvement against the pretreated state was noted. Partial wound dehiscence was reported in one patient, recurrence in three (3.75%) patients and widening of the scar was reported in 11 patients. Using a subjective scale, 67 (83.75%) patients reported a significant improvement in aesthetics, 10 (12.5%) a slight improvement, 3 (3.75%) reported an unchanged appearance. |