Renal Failure
Conditions
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.
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.
Interventions
BIOLOGICALMediHoney
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.
Sponsors
Dialysis Clinic, Inc.
University of Missouri-Columbia
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 90 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Time From Catheter Implantation to First Exit Site Infection. | Two years | 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. |
Countries
United States
Participant flow
Recruitment details
13 participants were recruited from surgical clinics.
Pre-assignment details
Data is unavailable as no analysis has occurred. The study was terminated to due loss of communication between the surgical and research departments.
Participants by arm
| Arm | Count |
|---|---|
| Surgical Catheter Dressings Participants randomized to either standard of care dressings or Medihoney dressings to catheter exit sites. The numbers allocated to each arm is unknown. Data is unavailable as no analysis has occurred. The study was terminated to due loss of communication between the surgical and research departments. | 13 |
| Total | 13 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Adverse Event | 2 |
| Overall Study | Death | 2 |
| Overall Study | Treatment modality changed | 1 |
Baseline characteristics
| Characteristic | Surgical Catheter Dressings | — |
|---|---|---|
| Age, Customized Age 18 - 90 years | 13 Participants | — |
| Race and Ethnicity Not Collected | — | — Participants |
| Region of Enrollment United States | 13 Participants | — |
| Sex/Gender, Customized Unknown | 13 Participants | — |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 2 / 13 |
| other Total, other adverse events | 0 / 13 |
| serious Total, serious adverse events | 2 / 13 |
Outcome results
Primary
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.
Time frame: Two years
Population: Data is unavailable as no analysis has occurred. The study was terminated to due loss of communication between the surgical and research departments.