Renal FailureNCT01230489
The Efficacy of "MediHoney" to Facilitate Catheter Exit-Site Surgical Wound Healing
A study testing MediHoney in people with Renal Failure, run by University of Missouri-Columbia at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Renal Failure
- What is being tested?
- MediHoney
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 13 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2011to 28 Nov 2016
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Patients younger than 18 years of age
- Prisoners
- Patients with mental defect
- Veteran Administration patients
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Missouri Department of Medicine; Dialysis Clinic, Inc.
Columbia, Missouri, 65201
About this study
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
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.
Read the 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.
- Conditions
- Renal Failure
- Being tested
- MediHoney
- Medical subject headings
- Renal Insufficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MediHoneyBiological
Also called Honeycolloid Dressing, Leptospermum honey
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Biological: MediHoney |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Two years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Oct 2010 (estimated)
- Study startJan 2011
- Primary completion28 Nov 2016
- Study completion28 Nov 2016
Why it stopped: Breakdown of communication between departments involved
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Renal FailureStudies of the same condition, open and under way.
- More trials run by University of Missouri-ColumbiaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 13 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Missouri-Columbia
- Sponsor type
- University, hospital or other
- Collaborators
- Dialysis Clinic, Inc.
- Responsible party
- Sponsor
- Investigators
- Harold L Moore, MA, Principal investigator, University of Missouri, School of Medicine, Department of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01230489
- Sponsor's protocol ID
- 1171097
- Status last verified
- Mar 2018
- First submitted
- 27 Oct 2010
- Last updated
- 17 Aug 2018
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01230489
- Acronym / sponsor ID
- 1171097
- Conditions
- Renal Failure
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Breakdown of communication between departments involved
- Enrolment
- 13 participants (actual)
- Lead sponsor
- University of Missouri-ColumbiaUniversity, hospital or other
- Collaborators
- Dialysis Clinic, Inc.
- Study start
- Jan 2011 (actual)
- Primary completion
- 28 Nov 2016 (actual)
- Study completion
- 28 Nov 2016 (actual)
- First posted
- 29 Oct 2010 (estimated)
- Results
- Posted 17 Aug 2018
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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 | Biological: MediHoneyThis 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. |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (4 listed)
- Patients younger than 18 years of age
- Prisoners
- Patients with mental defect
- Veteran Administration patients
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MediHoneyAlso: Honeycolloid Dressing, Leptospermum honeyIn 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. | Biological | MediHoney |
Primary outcome
Time From Catheter Implantation to First Exit Site Infection.
Time frame: 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.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Aug 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Harold L Moore, MA principal investigator
University of Missouri, School of Medicine, Department of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing MediHoney in people with Renal Failure, run by University of Missouri-Columbia at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 17 Aug 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 17 Aug 2018). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time From Catheter Implantation to First Exit Site Infection. (time frame: Two years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Aug 2018.