PACTR202004808998657.
| Study name | Fractional carbon dioxide laser versus fractional microneedle radiofrequency in the treatment of post burn scars: a comparative randomised split scar study |
| Methods | Randomised open‐label split scar study |
| Participants | Patients with post burn hypertrophic scars more than 1 year. Participants should be more than 16 years old, be both males and females. Patents with 2 separate lesions, each of them about 2 to 3 cm OR a single large sized lesion equal to or more than 10 cm. |
| Interventions | Fractional carbon dioxide laser: in each participant, a large lesion will be outlined and divided into 2 parts 2 to 3 cm apart so that 1 will be randomly assigned to fractional CO2 laser and the other 1 will receive fractional microneedle radiofrequency. If the lesion size was small 2 symmetrical lesions were picked. Topical anaesthesia will be applied beforehand. The parameters of fractional CO2 laser that will be used in the treatment 20 watt, 800 to 1000 μs dwell time, according to height 2 to 3 stacks, 500 μm spacing. All patents will receive 4 treatment sessions 6 weeks apart. Fractional microneedle radiofrequency: in each patient, a large lesion will be outlined and divided into 2 parts 2 cm to 3 cm apart so that 1 will be randomly assigned to fractional CO2 laser and the other 1 will receive fractional microneedle radiofrequency. If the lesion size is small 2 symmetrical lesions will be picked. The parameters of fractional microneedle radiofrequency; 7 to 8 v, exposure time: 800 ms. depth: 3 to 3.5 mm (using non‐insulated needles), frequency: 2 Hz. Topical anaesthesia will be applied beforehand. All patents will receive 4 treatment sessions 6 weeks apart. |
| Outcomes | Assessment will be done via : a) clinical evaluation: clinical assessment will be done by calculating patient and observer scar assessment scale before every session and 1 month after the last session. b) Photographic documentation: before every session and 1 month after least session. c) Histopathological and biochemical evaluation. Pre treatment biopsy: one 3 mm a punch biopsy will be taken per lesion to be treated prior to treatment sessions. Post treatment biopsy: one 3 mm punch biopsy will be taken per lesion 1 month after the last session. Biopsies will be fixed in 10% natural buffered formalin, and then embedded in paraffin blocks. Sections will be prepared for routine staining by H & E. Sections will be graded as regards the appearance and pattern of dermal collagen and elastin before and 1 month after the last session. Ten sections will be prepared for histochemical staining of collagen fibbers using Masson trichrome stain and elastic fibres using Orcein stain and will be evaluated by an image analyser. Biochemical evaluation: the tissue level of TGFβ1will be measured by ELISA in biopsies obtained from the scar area. |
| Starting date | Not reported |
| Contact information | Shereen Tawfic: shereemosamat@yahoo.com |
| Notes |
CO2: carbon dioxide;ELISA: enzyme‐linked immunosorbent assay; Pes QoL: Pediatric Quality of Life Inventory; POSAS: Patient and Observer Scar Assessment Scale.