Although partial thickness burns are the most frequently reported burn injuries, there is no consensus on the optimal treatment. The objective of this study was to compare the clinical... Show moreAlthough partial thickness burns are the most frequently reported burn injuries, there is no consensus on the optimal treatment. The objective of this study was to compare the clinical effectiveness and scar quality of Flaminal (R) Forte to silver sulfadiazine (Flamazine (R)) in the treatment of partial thickness burns. In this two-arm open label multicenter randomized controlled trial, adult patients with acute partial thickness burns and an affected total body surface area of less than 30% were randomized between Flaminal (R) Forte and Flamazine (R) and followed for 12months. Dressing changes in the Flamazine (R) group were performed daily, and in the Flaminal (R) group during the first 3days post burn and thereafter every other day until complete wound healing or surgery. Forty-one patients were randomly allocated to Flaminal (R) Forte and 48 patients to Flamazine (R). The primary outcome was time to wound healing, which did not differ between the groups: median 18days with Flaminal (R) Forte (range 8-49days) versus 16days with Flamazine (R) (range 7-48days; p=0.24). Regarding the secondary outcomes during hospital admission, there were no statistically significant differences between the groups concerning need for surgery, pain scores, pruritus, or pain-related and anticipatory anxiety. More patients in the Flaminal (R) group developed wound colonization (78% versus 32%, p<0.001), but the treatment groups did not differ regarding the incidence of local infections and use of systemic antibiotics. In terms of scar quality, no statistically significant differences between both treatment groups were found regarding subjective scar assessment (Patient and Observer Scar Assessment Scale (POSAS)), scar melanin and pigmentation (DermaSpectrometer (R)), and scar elasticity and maximal extension (Cutometer (R)) during 12month postburn. In conclusion, time to wound healing did not differ, but the use of Flaminal (R) Forte seemed favorable because less dressing changes are needed which lowers the burden of wound care. Show less
Although partial thickness burns are the most frequently reported burn injuries, there is no consensus on the optimal treatment. The objective of this study was to compare the clinical... Show moreAlthough partial thickness burns are the most frequently reported burn injuries, there is no consensus on the optimal treatment. The objective of this study was to compare the clinical effectiveness and scar quality of Flaminal® Forte to silver sulfadiazine (Flamazine®) in the treatment of partial thickness burns. In this two-arm open label multicenter randomized controlled trial, adult patients with acute partial thickness burns and an affected total body surface area of less than 30% were randomized between Flaminal® Forte and Flamazine® and followed for 12 months. Dressing changes in the Flamazine® group were performed daily, and in the Flaminal® group during the first 3 days post burn and thereafter every other day until complete wound healing or surgery. Forty-one patients were randomly allocated to Flaminal® Forte and 48 patients to Flamazine®. The primary outcome was time to wound healing, which did not differ between the groups: median 18 days with Flaminal® Forte (range 8-49 days) versus 16 days with Flamazine® (range 7-48 days; p = 0.24). Regarding the secondary outcomes during hospital admission, there were no statistically significant differences between the groups concerning need for surgery, pain scores, pruritus, or pain-related and anticipatory anxiety. More patients in the Flaminal® group developed wound colonization (78% versus 32%, p < 0.001), but the treatment groups did not differ regarding the incidence of local infections and use of systemic antibiotics. In terms of scar quality, no statistically significant differences between both treatment groups were found regarding subjective scar assessment (Patient and Observer Scar Assessment Scale (POSAS)), scar melanin and pigmentation (DermaSpectrometer®), and scar elasticity and maximal extension (Cutometer®) during 12 month postburn. In conclusion, time to wound healing did not differ, but the use of Flaminal® Forte seemed favorable because less dressing changes are needed which lowers the burden of wound care. Show less
Marck, R.E.; Gardien, K.L.M.; Stekelenburg, C.M.; Vehmeijer, M.; Baas, D.; Tuinebreijer, W.E.; ... ; Middelkoop, E. 2016
A multicenter prospective randomized clinical trial was undertaken to investigate the effectiveness of the Australian Medical Sheepskin (AMS) in the prevention of sacral pressure ulcers in somatic... Show moreA multicenter prospective randomized clinical trial was undertaken to investigate the effectiveness of the Australian Medical Sheepskin (AMS) in the prevention of sacral pressure ulcers in somatic nursing home patients. Patients were randomized at admission and were then followed daily for 30 days. The experimental group received usual care plus an AMS as a layer on the mattress within ultimately 48 hours after admission; the control group received usual care only. Usual care was all the care that nursing wards normally applied for pressure ulcer prevention without any further standardization for this study. A total of 588 patients were randomized (293 control and 295 experimental group) and the data of 543 patients could be analyzed (272 from the control and 271 from the experimental group). The incidence of sacral pressure ulcers grade 1 or higher was significantly lower in the experimental group than in the control group (8.9% vs. 14.7%). In a multilevel analysis on the incidence of pressure ulcers adjusted for Braden risk score, age, and gender, it shows an odds ratio of 0.53 (95% confidence interval: 0.29-0.95), meaning a significant protective effect of the AMS. These results are in line with the results of two earlier trials on the AMS in hospital patients. The majority of patients in our trial that used an AMS rated it positively, but one-third found the sheepskin too warm. We conclude that the AMS is an effective aid in the prevention of sacral pressure ulcers in nursing home patients. Show less
