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

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

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.

Study Overview

• Status: Withdrawn
• Conditions: Injuries and Wounds
• Intervention / Treatment: Drug: Aloe Vera Gel; Other: Ultrasound gel

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.

• Study Type: Interventional
• Phase: Phase 2; Phase 1

Contacts and Locations

Study Locations

• United Kingdom
  • Midlothian
    • Edinburgh, Midlothian, United Kingdom, EH16 4SA
      • Royal Infirmary Of Edinburgh

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Exclusion Criteria:

1. Known allergy to either Aloe Vera or ultrasound gel
2. Patients under 16 year of age
3. No telephone number for follow-up
4. Patient lacking capacity
5. Patient currently using antibiotics
6. Patient having a puncture or bite wound
7. Patient having underlying tendon or bone involvement or wound overlying a joint
8. Patients with burn wounds
9. Wounds more than 24 hours old
10. Patient unable/unwilling to attend follow-up
11. Patients unable to self administer treatment.
12. 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
13. Self reported pregnancy
14. Patients with a known allergy to the study dressing
15. Patients currently recruited in another clinical trial
16. Patients already recruited in the ALOE Study

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Standard care
Experimental: Aloe Vera Gel; Experimental gel placed in identical opaque tube as placebo gel.	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 Names: Aloe Vera Gel (LIFEPLAN)
Placebo Comparator: Ultrasound Gel; Placebo placed in identical opaque tube as experimental gel.	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.; Other Names: Sterile (AQUASONIC 100) ultrasound transmission gel

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Number of days for wound to heal (defined as epithelial closure without discharge or scab formation)	Day 21 (+/- 2 days)

Secondary Outcome Measures

Outcome Measure	Time Frame
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)

Collaborators and Investigators

• Sponsor: NHS Lothian
• Collaborators: University of Edinburgh
• Investigators: Principal Investigator: Matthew J Reed, MA FRCEM MD, NHS Lothian

Study record dates

Study Major Dates

• Study Start (Anticipated): April 1, 2017
• Primary Completion (Anticipated): February 1, 2019
• Study Completion (Anticipated): February 1, 2019

Study Registration Dates

• First Submitted: June 28, 2016
• First Submitted That Met QC Criteria: June 28, 2016
• First Posted (Estimate): June 30, 2016

Study Record Updates

• Last Update Posted (Actual): February 17, 2017
• Last Update Submitted That Met QC Criteria: February 15, 2017
• Last Verified: February 1, 2017

More Information

Terms related to this study

• Keywords: Aloe Vera, wound, healing
• Additional Relevant MeSH Terms: Pathologic Processes; Disease Attributes; Emergencies; Wounds and Injuries
• Other Study ID Numbers: AC16063

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No