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临床试验/NCT02819817
NCT02819817撤回1 期

A Parallel Group Double Blind Placebo Randomised Controlled Trial (RCT) of Topical Aloe Vera Gel in Emergency Department (ED) Patients Presenting With Simple Traumatic Wounds

NHS Lothian1 个研究点 分布在 1 个国家开始时间: 2017年4月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
1 期
状态
撤回
发起方
NHS Lothian
试验地点
1
主要终点
Number of days for wound to heal (defined as epithelial closure without discharge or scab formation)

研究概览

简要总结

This is a double blind placebo-controlled RCT comparing the speed of healing of simple traumatic wounds with Aloe Vera gel compared to both control (Ultrasound gel) and standard care.

详细描述

Simple traumatic wounds are a common presenting symptom to the ED affecting thousands of patients worldwide every day. Aloe Vera is a natural product that has been linked to better healing both anecdotally and in animal studies. A recent Cochrane review failed to find any human studies on acute wounds such as those seen in the ED. The aim of this study is to see whether Aloe Vera gel improves the wound healing time in these patients. We plan to enrol 270 participants presenting to the Royal Infirmary of Edinburgh ED with simple traumatic wounds into a randomised controlled trial. Participants will be assessed at baseline using the Bates-Jensen wound assessment tool. They will be then be randomized to one of three groups, and allocated to receive either Aloe Vera gel, control (Ultrasound gel) or standard care. The participants in the two gel groups will have identical packaging and the treating clinician will be unaware as to which group they are allocated. They will be asked to place the allocated substance onto the wound twice daily and cover with a supplied dressing on each occasion for 1 week. All groups will be asked to return to the ED for a repeat Bates-Jensen wound assessment, and will also be asked to record the number of days that their wound took to heal. The gel groups will have assessment of product usage. Participants will also be telephoned at 3 weeks. Primary outcome will be number of days for wound to heal. Secondary outcome will be change in Bates-Jensen wound assessment score between baseline and day 10, change in wound size between baseline and day 10 and baseline and day 21, changes in wound characteristics at day 21 as reported by participants, wound infection rate, participant satisfaction and participant compliance with treatment.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

入排标准

年龄范围
16 Years 至 —(Child, Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patients deemed by their treating clinician to have a simple traumatic wound will be considered for enrolment.

排除标准

  • Known allergy to either Aloe Vera or ultrasound gel
  • Patients under 16 year of age
  • No telephone number for follow-up
  • Patient lacking capacity
  • Patient currently using antibiotics
  • Patient having a puncture or bite wound
  • Patient having underlying tendon or bone involvement or wound overlying a joint
  • Patients with burn wounds
  • Wounds more than 24 hours old
  • Patient unable/unwilling to attend follow-up
  • Patients unable to self administer treatment.
  • Wound that treating clinician would not routinely dress e.g. facial wounds (face, ear, eyebrow, nose, lip, eyelid, scalp), mucosa and hair covered areas, or wounds that require specialist dressing
  • Self reported pregnancy
  • Patients with a known allergy to the study dressing
  • Patients currently recruited in another clinical trial
  • Patients already recruited in the ALOE Study

研究组 & 干预措施

Aloe Vera Gel

Experimental

Experimental gel placed in identical opaque tube as placebo gel.

干预措施: Aloe Vera Gel (Drug)

Ultrasound Gel

Placebo Comparator

Placebo placed in identical opaque tube as experimental gel.

干预措施: Ultrasound gel (Other)

结局指标

主要结局

Number of days for wound to heal (defined as epithelial closure without discharge or scab formation)

时间窗: Day 21 (+/- 2 days)

次要结局

  • Numerical change in Bates-Jensen wound assessment score between baseline and day 10 (+/- 2 days)(Baseline and day 10 (+/- 2 days))
  • Size (width and height in mm) of wound at baseline, day 10 (+/- 2 days), and day 21 (+/- 2 days)(Baseline, day 10 (+/- 2 days) and day 21 (+/- 2 days))
  • Characteristics (visibility of wound edges and leakage from wound) as reported by participant at day 21 (+/- 2 days)(Day 21 (+/- 2 days))
  • Wound infection rate(Day 21 (+/- 2 days))
  • Participant satisfaction score(Day 21 (+/- 2 days))
  • Participant treatment compliance (i.e. the total weight of gel used)(Day 10 (+/- 2 days))

研究者

发起方
NHS Lothian
申办方类型
Other Gov
责任方
Sponsor

研究点 (1)

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