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.
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
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
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.
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.
Royal Infirmary of Edinburgh
Edinburgh, Midlothian, United Kingdom
Number of days for wound to heal (defined as epithelial closure without discharge or scab formation)
Time frame: Day 21 (+/- 2 days)
Numerical change in Bates-Jensen wound assessment score between baseline and day 10 (+/- 2 days)
Time frame: 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)
Time frame: 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)
Time frame: Day 21 (+/- 2 days)
Wound infection rate
Time frame: Day 21 (+/- 2 days)
Participant satisfaction score
Time frame: Day 21 (+/- 2 days)
Participant treatment compliance (i.e. the total weight of gel used)
Time frame: Day 10 (+/- 2 days)
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