title: [Multi-center clinical trial of FLAMIGEL (hydrogel dressing) for the treatment of residual burn wound].
abstract: OBJECTIVE
  To evaluate the effect of FLAMIGEL (hydrogel dressing) on the repair of residual burn wound.
  
  
  METHODS
  Sixty burn patients with residual wounds hospitalized in 6 burn units from November 2011 to May 2012 were enrolled in the multi-center, randomized, and self-control clinical trial. Two residual wounds of each patient were divided into groups T (treated with FLAMIGEL) and C (treated with iodophor gauze) according to the random number table. On post treatment day (PTD) 7 and 14, wound healing rate was calculated, with the number of completely healed wound counted. The degree of pain patient felt during dressing change was evaluated using the visual analogue scale (VAS). The mean numbers of wounds with score equal to zero, more than zero and less than or equal to 3, more than 3 and less than or equal to 6, more than 6 and less than or equal to 10 were recorded respectively. Wound secretion or exudate samples were collected for bacterial culture, and the side effect was observed. Data were processed with repeated measure analysis of variance, t test, chi-square test, and nonparametric rank sum test.
  
  
  RESULTS
  Wound healing rate of groups T, C on PTD 7 was respectively (67 ± 24)%, (45 ± 25)%, and it was respectively (92 ± 16)%, (72 ± 23)% on PTD 14. There was statistically significant difference in wound healing rate on PTD 7, 14 between group T and group C (F = 32.388, P < 0.01). Ten wounds in group T and four wounds in group C were healed completely on PTD 7, with no significant difference between them (χ(2) = 0, P > 0.05). Forty-two wounds in group T and seven wounds in group C healed completely on PTD 14, with statistically significant difference between them (χ(2) = 42.254, P < 0.01). Patients in group T felt mild pain during dressing change for 37 wounds, with VAS score higher than zero and lower than or equal to 3. Evident pain was observed in patients of group C during dressing change for 43 wounds, and it scored higher than 3 and less than or equal to 6 by VAS evaluation. There was statistically significant difference in mean number of wounds with different grade of VAS score between group T and group C (Z = -4.638, P < 0.01). Staphylococcus aureus, Pseudomonas aeruginosa, Klebsiella pneumoniae, E. coli, Baumanii, and Staphylococcus epidermidis were all detected in both groups, but there was no statistical difference between group T and group C (χ(2) = 0.051, P > 0.05). No side effect was observed in either of the two groups during the whole trial.
  
  
  CONCLUSIONS
  FLAMIGEL can accelerate the healing of residual burn wounds and obviously relieve painful sensation during dressing change.
authors.affiliation: Department of Burns and Plastic Surgery, Ruijin Hospital, Shanghai Jiao Tong University School of Medicine, Shanghai 200025, China.
authors.forename: Hui-zhong
authors.initials: HZ
authors.lastname: Yang
authors.forename: Wen-kui
authors.initials: WK
authors.lastname: Wang
authors.forename: Li-li
authors.initials: LL
authors.lastname: Yuan
authors.forename: Shun-bin
authors.initials: SB
authors.lastname: Wang
authors.forename: Gao-xing
authors.initials: GX
authors.lastname: Luo
authors.forename: Jun
authors.initials: J
authors.lastname: Wu
authors.forename: Xi-hua
authors.initials: XH
authors.lastname: Niu
authors.forename: Bing-wei
authors.initials: BW
authors.lastname: Sun
authors.forename: Guang-gang
authors.initials: GG
authors.lastname: DU
authors.forename: Hai-hui
authors.initials: HH
authors.lastname: Li
authors.forename: Shun
authors.initials: S
authors.lastname: Chen
authors.forename: Zhao-hong
authors.initials: ZH
authors.lastname: Chen
authors.forename: Cheng-de
authors.initials: CD
authors.lastname: Xia
authors.forename: Shu-ren
authors.initials: SR
authors.lastname: Li
authors.forename: Tao
authors.initials: T
authors.lastname: Lü
authors.forename: Hui
authors.initials: H
authors.lastname: Sun
authors.forename: Xi
authors.initials: X
authors.lastname: Chen
authors.forename: Xiao-long
authors.initials: XL
authors.lastname: He
authors.forename: Bing
authors.initials: B
authors.lastname: Zhang
authors.forename: Jing-ning
authors.initials: JN
authors.lastname: Huan
mesh_terms: D000293:Adolescent; D000328:Adult; D000368:Aged; D001458:Bandages; D002056:Burns / Q000628:therapy*; D005260:Female; D006801:Humans; D020100:Hydrogels; D008297:Male; D008875:Middle Aged; D055815:Young Adult
chemical_list: D020100:Hydrogels