Comparison of RO with standard dressings for treatment of ulcers
Research type
Research Study
Full title
A pilot study to compare 'Surgihoney' (RO) with conventional dressings in the treatment of bilateral venous leg ulcers
IRAS ID
191289
Contact name
Alok Tiwari
Contact email
Sponsor organisation
University Hospitals Birmingham NHS Foundation Tru
Duration of Study in the UK
1 years, 0 months, 0 days
Research summary
Leg ulcers can be very difficult to treat and in some patients difficult to heal with the standard of care treatments provided. These treatments include dressings that contain antibacterial (bacteria-killing) agents such as silver, or iodine, and can be ineffective since bacteria can become resistant to the killing effects of the dressing agents.
‘Surgihoney (Reactive oxygen)’ (SHRO) is a newly licensed medical device based on natural organic honey. Honey is a well-known wound care product and has both antibacterial, and wound healing properties. Laboratory investigations performed here at the hospital have shown that SHRO is antibacterial against a wide range of important bacteria, and additionally, clinical improvements have been reported from a large number of patients treated with the product. However to date no properly controlled studies have been performed.
The product is CE licensed for use on diabetic leg and foot ulcers. The purpose of the study is to see if the favourable outcomes with SHRO that we see in patients treated on an ad hoc basis still occurs when a small number of patients with bilateral venous leg ulcers (where one patient has ulcers present on both legs) are treated with SHRO on one leg and standard antibacterial dressing (Aquacel Ag) on the other leg in a controlled setting.
The study would be performed at the Queen Elizabeth Hospital, Birmingham, and patients with long-term ulcers present (for greater than 6 weeks) on both legs that have showed no signs of improvement (despite >6 weeks of standard treatment) would be invited to take part. This will involve one ulcer being treated with SHRO, and the other with the standard antimicrobial dressing (that would be part of normal care) with dressing changes twice weekly. The ulcers would then be monitored over 6 weeks to see if there are any differences in ulcer healing.REC name
West Midlands - Black Country Research Ethics Committee
REC reference
16/WM/0320
Date of REC Opinion
20 Sep 2016
REC opinion
Further Information Favourable Opinion