NCT02819817

A Trial of Topical Aloe Vera Gel in Emergency Department Patients Presenting With Simple Traumatic Wounds

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

• Status: Withdrawn
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: NHS Lothian · Other Government
• Sex: All
• Age: 16 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Injuries and Wounds

Interventions

Type	Name	Description
DRUG	Aloe Vera Gel	The participant 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.
OTHER	Ultrasound gel	The participant 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.

Timeline

• Start date: 2017-04-01
• Primary completion: 2019-02-01
• Completion: 2019-02-01
• First posted: 2016-06-30
• Last updated: 2017-02-17

Locations

1 site across 1 country: United Kingdom