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

NHS Lothian

Status and phase: Withdrawn; Phase 2; Phase 1

Conditions: Injuries and Wounds

Treatments: Drug: Aloe Vera Gel; Other: Ultrasound gel

Study type: Interventional

Funder types: Other

Identifiers

NCT02819817

AC16063

Details and patient eligibility

About

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.

Full 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.

Sex: All

Ages: 16+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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0 participants in 3 patient groups, including a placebo group

Aloe Vera Gel

Experimental group

Description:

Experimental gel placed in identical opaque tube as placebo gel.

Treatment:

Drug: Aloe Vera Gel

Ultrasound Gel

Placebo Comparator group

Description:

Placebo placed in identical opaque tube as experimental gel.

Treatment:

Other: Ultrasound gel

Standard care

No Intervention group

Description:

Standard care