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

NCT01230489 | Terminated Results

• 1 other identifier: 1171097
• Study Type: interventional
• Target: 13
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Renal Failure

Outcome Measures

Primary Outcomes (1)

• Time From Catheter Implantation to First Exit Site Infection.

  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.

  Two years

Study Arms (2)

Standard Care

NO INTERVENTION

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.

MediHoney

EXPERIMENTAL

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

Interventions

MediHoney BIOLOGICAL

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.

Also known as: Honeycolloid Dressing, Leptospermum honey

MediHoney

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Patients younger than 18 years of age
• Prisoners
• Patients with mental defect
• Veteran Administration patients

Sponsors & Collaborators

• University of Missouri-Columbia: lead
• Dialysis Clinic, Inc.: collaborator

Study Sites (1)

University of Missouri Department of Medicine; Dialysis Clinic, Inc.

Columbia, Missouri, 65201, United States

Location

MeSH Terms

Conditions

Renal Insufficiency

Condition Hierarchy (Ancestors)

Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases

Results Point of Contact

• Title: Harold Moore
• Organization: University of Missouri-Columbia

mooreh@health.missouri.edu

5738824433

Study Officials

• Harold L Moore, MA

  University of Missouri, School of Medicine, Department of Medicine

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 27, 2010
• First Posted: October 29, 2010
• Study Start: January 1, 2011
• Primary Completion: November 28, 2016
• Study Completion: November 28, 2016
• Last Updated: August 17, 2018
• Results First Posted: August 17, 2018

Record last verified: 2018-03

Locations

US (1)