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

Injuries and Wounds Clinical Trial

— ALOE  

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT02819817
• Other study ID #: AC16063
• Status: Withdrawn
• Phase: Phase 1/Phase 2
• First received: June 28, 2016
• Last updated: February 15, 2017
• Start date: April 2017
• Est. completion date: February 2019

Study information

• Verified date: February 2017
• Source: NHS Lothian
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: February 2019
• Est. primary completion date: February 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 16 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Emergencies
• Injuries and Wounds
• Wounds and Injuries

Intervention

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.

Locations

Country	Name	City	State
United Kingdom	Royal Infirmary of Edinburgh	Edinburgh	Midlothian

Sponsors (2)

Lead Sponsor	Collaborator
NHS Lothian	University of Edinburgh

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of days for wound to heal (defined as epithelial closure without discharge or scab formation)		Day 21 (+/- 2 days)
Secondary	Numerical change in Bates-Jensen wound assessment score between baseline and day 10 (+/- 2 days)		Baseline and day 10 (+/- 2 days)
Secondary	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)
Secondary	Characteristics (visibility of wound edges and leakage from wound) as reported by participant at day 21 (+/- 2 days)		Day 21 (+/- 2 days)
Secondary	Wound infection rate		Day 21 (+/- 2 days)
Secondary	Participant satisfaction score		Day 21 (+/- 2 days)
Secondary	Participant treatment compliance (i.e. the total weight of gel used)		Day 10 (+/- 2 days)