The Efficacy of "MediHoney" to Facilitate Catheter Exit-Site Surgical Wound Healing
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||The Efficacy of "MediHoney" to Facilitate Catheter Exit-Site Surgical Wound Healing and Prevention of Wound Bacterial Colonization: A Randomized, Open-label, Controlled, Clinical Trial|
- Time from catheter implantation to first exit site infection. [ Time Frame: Two years ] [ Designated as safety issue: No ]The outcome measure is the length of time from implantation until the patient has first exit site infection or two years which ever is shortest.
|Study Start Date:||January 2011|
|Estimated Study Completion Date:||September 2017|
|Estimated Primary Completion Date:||September 2017 (Final data collection date for primary outcome measure)|
No Intervention: Standard Care
This group will undergo the current standard of care for post operative exit sites at the involved institutions. This group will act as the control or the group to which the interventional group will be compared too.
This study group will have the dry 2 x 2 dressing replaced with a honey 2 x 2 dressing. Additionally all indentations in the exit site wound will be filled with honey ointment prior to the application of the dressing.
In this group a Medihoney 2 x 2 will be used in place of the standard dry 2 x 2 currently used as the wound dressing. Also all indentations of the wound will be filled with Medi-Honey ointment prior to the application of the dressing.
The exit site (ES) of any transcutaneous device, or foreign body, through the skin presents as the site most vulnerable in terms of device survival. With the large numbers of catheters in use in chronic dialysis today exit-site care for the prevention of infection is of critical importance in reducing morbidity and mortality. Pericatheter infection is the number one cause of catheter loss in peritoneal dialysis patients.
It appears that honey is a compound with a multi-factorial mode of action. It is thought that with most honeys, the antimicrobial action stems from its high osmolality and the fact that it produces continuous non-cytotoxic levels of hydrogen peroxide due to enzymatic break down of the sugar. Honey also has a low pH which is not conducive for most bacterial growth but is good for wound healing.
Observational reports have shown some success in healing infected wounds, ulcers, protection of plastic surgery transplants, burns, herpetic skin lesions, and atopic dermatitis. Honey has also been shown to have antimicrobial action against a broad spectrum of fungi and bacteria including antibiotic resistant bacteria. Another study reports that honey reduces inflammation, edema, and promotes angiogenesis.
In an animal study of urethral injury it was shown that contrary to controls, there was a total healing with restoration of normal urethral epithelium and connective tissue with complete absence of fibrosis and inflammation. There was also no narrowing of the lumen as seen in the other study groups.
A study of prophylactic exit-site care of hemodialysis catheters comparing honey and Mupirocin demonstrated that results with honey were comparable to that of Mupirocin. However, unlike Mupirocin, there has not been an emergence of honey-resistant bacterial strains which makes it an attractive alternative agent.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01230489
|United States, Missouri|
|University of Missouri Department of Medicine; Dialysis Clinic, Inc.|
|Columbia, Missouri, United States, 65201|
|Principal Investigator:||Harold L Moore, MA||University of Missouri, School of Medicine, Department of Medicine|