Safety of troclosene sodium solution in decontamination of wounds: A prospective clinical and laboratory study.

Debate persists regarding the safety of hypochlorite‐containing solutions in the decontamination of infected wounds. In 2006, the Israeli Ministry of Health withdrew licensing approval for troclosene sodium as a wound irrigation solution. The aim of this prospective clinical and laboratory study was...

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Publicado en:Wound Repair & Regeneration Vol. 31; no. 5; pp. 635 - 641
Autores principales: Segal, Miriam, Metanes, Issa, O'Boyle, Ciaran P., Sadeh, Omer, Hassan, Samer, Bryzgalin, Leonid, Lavi, Idit, Franco, Eyal, Har‐Shai, Yaron
Formato: research tables/charts Journal Article
Publicado: Wiley-Blackwell Sep/Oct2023
Acceso en línea:Ver este registro en EBSCOhost
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      dt: Sep/Oct2023
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      pub: Wiley-Blackwell
      place: Malden, Massachusetts
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        10.1111/wrr.13105
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        atl: Safety of troclosene sodium solution in decontamination of wounds: A prospective clinical and laboratory study.
      aug:
        au:
          Segal, Miriam
          Metanes, Issa
          O'Boyle, Ciaran P.
          Sadeh, Omer
          Hassan, Samer
          Bryzgalin, Leonid
          Lavi, Idit
          Franco, Eyal
          Har‐Shai, Yaron
        affil: Department of Plastic Surgery, The Lady Davis Carmel Medical Center, Haifa, Israel
      sug:
        subj:
          Wound Infection Drug Therapy
          Sodium Compounds Therapeutic Use
          Sodium Compounds Adverse Effects
          Drug Efficacy Evaluation
          Patient Safety
          Human
          Male
          Female
          Middle Age
          Aged
          Israel
          Prospective Studies
          Wound Care
          Descriptive Statistics
          Two-Tailed Test
          Pain Management
          Edema
          Erythema
          Granulation Tissue
          Exudates and Transudates
          Microbial Culture and Sensitivity Tests
          Wounds and Injuries Microbiology
          Middle Aged: 45-64 years
          Aged: 65+ years
          Male
          Female
      ab: Debate persists regarding the safety of hypochlorite‐containing solutions in the decontamination of infected wounds. In 2006, the Israeli Ministry of Health withdrew licensing approval for troclosene sodium as a wound irrigation solution. The aim of this prospective clinical and laboratory study was to investigate the safety of troclosene sodium solution for decontamination of infected wounds. Troclosene sodium solution was used to treat 30 patients with 35 infected skin wounds of various etiologies and body areas, over a treatment period of 8 days. Data were gathered according to a prospectively designed protocol including general findings, wound‐specific observations on Day 1 and Day 8 and laboratory parameters on Day 1 and Day 8. Wound swabs and tissue biopsy for culture were taken on Day 1 and Day 8. Statistical analysis was executed. Tests were 2‐sided and p values of <0.05 were considered statistically significant. Eighteen males and 12 females, with 35 infected skin wounds were enrolled. There were no adverse clinical events. No significant changes were observed in general clinical observations. Statistically significant improvements were observed in: pain (p < 0.0001); edema (p < 0.0001); area of wound covered by granulation tissue (p < 0.0001); exudate (p < 0.0001); and erythema (p = 0.002). Prior to treatment, bacteria were demonstrated on microscopy or on culture in 90% of wound samples. On Day 8, this frequency reduced to 40%. There were no abnormal laboratory tests. Serum sodium concentration increased significantly between Day 1 and Day 8, whilst serum concentration of urea and concentrations of thrombocytes, leucocytes and neutrophils showed statistically significant reductions, but all values remained within normal laboratory ranges throughout the study period. Troclosene sodium solution is clinically safe in the management of infected wounds. These findings were presented to the Israel Ministry of Health and as a result, troclosene sodium was re‐approved and licensed for decontamination of infected wounds in Israel.
      pubtype: Academic Journal
      doctype:
        research
        tables/charts
        Journal Article
      ougenre: Article
    language: English
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