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

NCT02819817 | Withdrawn Phase 1

• 1 other identifier: AC16063
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Injuries and Wounds

Keywords

Aloe Vera, wound, healing

Outcome Measures

Primary Outcomes (1)

• Number of days for wound to heal (defined as epithelial closure without discharge or scab formation)

  Day 21 (+/- 2 days)

Secondary Outcomes (6)

• Numerical change in Bates-Jensen wound assessment score between baseline and day 10 (+/- 2 days)

  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)

  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)

  Day 21 (+/- 2 days)

• Wound infection rate

  Day 21 (+/- 2 days)

• Participant satisfaction score

  Day 21 (+/- 2 days)

Study Arms (3)

Aloe Vera Gel

EXPERIMENTAL

Experimental gel placed in identical opaque tube as placebo gel.

Drug: Aloe Vera Gel

Ultrasound Gel

PLACEBO COMPARATOR

Placebo placed in identical opaque tube as experimental gel.

Other: Ultrasound gel

Standard care

NO INTERVENTION

Standard care

Interventions

Aloe Vera Gel 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.

Also known as: Aloe Vera Gel (LIFEPLAN)

Aloe Vera Gel

Ultrasound gel 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.

Also known as: Sterile (AQUASONIC 100) ultrasound transmission gel

Ultrasound Gel

Eligibility Criteria

• Age: 16 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may not qualify if:

• Known allergy to either Aloe Vera or ultrasound gel
• Patients under 16 year of age
• No telephone number for follow-up
• Patient lacking capacity
• Patient currently using antibiotics
• Patient having a puncture or bite wound
• Patient having underlying tendon or bone involvement or wound overlying a joint
• Patients with burn wounds
• Wounds more than 24 hours old
• Patient unable/unwilling to attend follow-up
• Patients unable to self administer treatment.
• 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
• Self reported pregnancy
• Patients with a known allergy to the study dressing
• Patients currently recruited in another clinical trial

Sponsors & Collaborators

• NHS Lothian: lead
• University of Edinburgh: collaborator

Study Sites (1)

Royal Infirmary of Edinburgh

Edinburgh, Midlothian, EH16 4SA, United Kingdom

Location

MeSH Terms

Conditions

Wounds and Injuries

Interventions

Aloe vera gel

Study Officials

• Matthew J Reed, MA FRCEM MD

  NHS Lothian

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 28, 2016
• First Posted: June 30, 2016
• Study Start: April 1, 2017
• Primary Completion: February 1, 2019
• Study Completion: February 1, 2019
• Last Updated: February 17, 2017

Record last verified: 2017-02

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)