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临床试验/ACTRN12617000412336
ACTRN12617000412336终止未知

Impact of Compression Therapy on Cellulitis (ICTOC) in adults with chronic oedema: a randomised controlled trial

Calvary Public Hospital Bruce0 个研究点目标入组 84 人开始时间: 2017年3月22日最近更新:
适应症

试验速览

阶段
未知
状态
终止
发起方
入组人数
84

研究概览

简要总结

Research questions: 1. To determine if compression therapy prevents the recurrence of lower limb cellulitis in adults with lower limb chronic oedema and recurrent cellulitis. 2. To determine and compare the cost of an episode of cellulitis and the cost of compression therapy over 18-months from both patient and health service perspectives. Background information and results: Trial inclusion criteria included adults with chronic oedema and a history of 2 or more episodes of cellulitis in the same leg in the 2 years prior to trial referral. Participants were randomised to receive either education regarding cellulitis prevention (control group) or the same education plus compression therapy (experimental group). Participants were planned to be followed up 6-monthly for up to 3 years or until 45 episodes of cellulitis occurred. The primary outcome was time to cellulitis recurrence. At the time of a planned interim analysis, cellulitis had recurred in 6 (15%) of the experimental group participants, and 17 (40%) of the control group participants, giving a hazard ratio of 0.23 (95% CI, 0.09 to 0.59; P=0.002). During the RCT, the mean annual cost per participant was $4972 in the experimental group and $26,382 in the control group, giving a cost saving of $21,483 (95% CI, 3136–48,176) per participant.

研究设计

研究类型
Interventional
分配方式
Randomised controlled trial
主要目的
Prevention
盲法
Open (masking not used)

入排标准

年龄范围
18 Years 至 o limit(—)
性别
All

入选标准

  • 1. The patients is over 18 years of age
  • 2. The patient is identified as having chronic oedema (oedema persisting more than 3 months) in one or both legs
  • 3. The patient has a history of 2 or more episodes of cellulitis in the past 2 years
  • 4. The patient is able to understand their involvement in the study, as per the information sheet
  • 5.The patient is able to give informed consent
  • 6. The patient has a valid Medicare card
  • 7. The patient is able to attend regular scheduled appointments

排除标准

  • 1. The patient is currently receiving chronic oedema management that involves compression
  • 2. The patient declines to participate or is unable to participate for whatever reason
  • 3. The patient is receiving end of life care
  • 4. The patient is medically unstable
  • 5.The patient has wounds requiring treatment that prevents use of compression garments
  • 6. The patient is unable to wear compression (unable to don/doff garments or has a medical condition that contraindicates use of compression)

研究者

发起方
Calvary Public Hospital Bruce

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