The Efficacy of "MediHoney" to Facilitate Catheter Exit-Site Surgical Wound Healing

This study is enrolling participants by invitation only.
Sponsor:
Collaborator:
Dialysis Clinic, Inc.
Information provided by (Responsible Party):
Harold L. Moore, University of Missouri-Columbia
ClinicalTrials.gov Identifier:
NCT01230489
First received: October 27, 2010
Last updated: September 30, 2011
Last verified: September 2011
  Purpose

To evaluate the efficacy of honey as a post surgical exit site care process to promote healing and prevent infectious bacterial colonization of newly created exit sites. It has been shown in the medical literature that honey has properties that are conducive to healing and the prevention of infection. In one study it was demonstrated that in urethral injury in the rat treated with honey the injury healed with none of the usual formation of fibrous tissue seen in such healing processes, that there was no reduction in the luminal diameter usually seen, and that the cells lining the urethra were uncompromised in any way, i.e. totally normal and healthy. We feel that if an exit site can be healed quickly with good normal tissue being developed that the patient will have a much better chance to keep that exit healthy reducing time, cost, and disruption of lifestyle. Other positive aspects of honey are it has the low pH required for good healthy tissue healing, it works in the presence of wound fluids, and it has never been shown to produce a resistant bacterial strain.


Condition Intervention
Renal Failure
Biological: MediHoney

Study Type: Interventional
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

Further study details as provided by University of Missouri-Columbia:

Primary Outcome Measures:
  • 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.


Estimated Enrollment: 128
Study Start Date: January 2011
Estimated Study Completion Date: September 2015
Estimated Primary Completion Date: September 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.
Experimental: MediHoney
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.
Biological: MediHoney
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.
Other Names:
  • Honeycolloid Dressing
  • Leptospermum honey
  • Medihoney

Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   18 Years to 90 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients requiring dialysis due to loss of kidney function
  • Patients choosing Peritoneal Dialysis (PD) for treatment
  • All PD patients having an indwelling PD catheter placed

Exclusion Criteria:

  • Patients younger than 18 years of age
  • Prisoners
  • Patients with mental defect
  • Veteran Administration patients
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01230489

Locations
United States, Missouri
University of Missouri Department of Medicine; Dialysis Clinic, Inc.
Columbia, Missouri, United States, 65201
Sponsors and Collaborators
University of Missouri-Columbia
Dialysis Clinic, Inc.
Investigators
Principal Investigator: Harold L Moore, MA University of Missouri, School of Medicine, Department of Medicine
  More Information

No publications provided

Responsible Party: Harold L. Moore, Research Associate, University of Missouri-Columbia
ClinicalTrials.gov Identifier: NCT01230489     History of Changes
Other Study ID Numbers: 1771097
Study First Received: October 27, 2010
Last Updated: September 30, 2011
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Renal Insufficiency
Kidney Diseases
Urologic Diseases

ClinicalTrials.gov processed this record on April 17, 2014