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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02819817
Recruitment Status : Withdrawn (MHRA CTA rejected due to no UK MHRA MA certificate or equivalent product info)
First Posted : June 30, 2016
Last Update Posted : February 17, 2017
Sponsor:
Collaborator:
University of Edinburgh
Information provided by (Responsible Party):
NHS Lothian

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.

Condition or disease Intervention/treatment Phase
Injuries and Wounds Drug: Aloe Vera Gel Other: Ultrasound gel Phase 1 Phase 2

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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
Estimated Study Start Date : April 2017
Estimated Primary Completion Date : February 2019
Estimated Study Completion Date : February 2019

Resource links provided by the National Library of Medicine

Drug Information available for: Aloe vera

Arm Intervention/treatment
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 Name: 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 Name: Sterile (AQUASONIC 100) ultrasound transmission gel

No Intervention: Standard care
Standard care



Primary Outcome Measures :
  1. Number of days for wound to heal (defined as epithelial closure without discharge or scab formation) [ Time Frame: Day 21 (+/- 2 days) ]

Secondary Outcome Measures :
  1. Numerical change in Bates-Jensen wound assessment score between baseline and day 10 (+/- 2 days) [ Time Frame: Baseline and day 10 (+/- 2 days) ]
  2. Size (width and height in mm) of wound at baseline, day 10 (+/- 2 days), and day 21 (+/- 2 days) [ Time Frame: Baseline, day 10 (+/- 2 days) and day 21 (+/- 2 days) ]
  3. Characteristics (visibility of wound edges and leakage from wound) as reported by participant at day 21 (+/- 2 days) [ Time Frame: Day 21 (+/- 2 days) ]
  4. Wound infection rate [ Time Frame: Day 21 (+/- 2 days) ]
  5. Participant satisfaction score [ Time Frame: Day 21 (+/- 2 days) ]
  6. Participant treatment compliance (i.e. the total weight of gel used) [ Time Frame: Day 10 (+/- 2 days) ]


Information from the National Library of Medicine

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Ages Eligible for Study:   16 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02819817


Locations
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United Kingdom
Royal Infirmary of Edinburgh
Edinburgh, Midlothian, United Kingdom, EH16 4SA
Sponsors and Collaborators
NHS Lothian
University of Edinburgh
Investigators
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Principal Investigator: Matthew J Reed, MA FRCEM MD NHS Lothian

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Responsible Party: NHS Lothian
ClinicalTrials.gov Identifier: NCT02819817    
Other Study ID Numbers: AC16063
First Posted: June 30, 2016    Key Record Dates
Last Update Posted: February 17, 2017
Last Verified: February 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by NHS Lothian:
Aloe Vera, wound, healing
Additional relevant MeSH terms:
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Emergencies
Wounds and Injuries
Disease Attributes
Pathologic Processes