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

NCT ID: NCT02819817

Last Updated: 2017-02-17

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: PHASE1/PHASE2
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-04-30
• Study Completion Date: 2019-02-28

Brief 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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Aloe Vera Gel

Experimental gel placed in identical opaque tube as placebo gel.

Group Type: EXPERIMENTAL

Aloe Vera Gel

Intervention Type: DRUG

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.

Ultrasound Gel

Placebo placed in identical opaque tube as experimental gel.

Group Type: PLACEBO_COMPARATOR

Ultrasound gel

Intervention Type: OTHER

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.

Standard care

Standard care

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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.

Intervention Type: DRUG

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.

Intervention Type: OTHER

Other Intervention Names

Aloe Vera Gel (LIFEPLAN); Sterile (AQUASONIC 100) ultrasound transmission gel

Eligibility Criteria

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

• Minimum Eligible Age: 16 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Edinburgh

OTHER

Sponsor Role: collaborator

NHS Lothian

OTHER_GOV

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Matthew J Reed, MA FRCEM MD

Role: PRINCIPAL_INVESTIGATOR

NHS Lothian

Locations

Royal Infirmary of Edinburgh

Edinburgh, Midlothian, United Kingdom

Countries

United Kingdom

Other Identifiers

AC16063

Identifier Type: -

Identifier Source: org_study_id