Disorder of Skin Donor SitePhase 4NCT02400372
The Effect of Anti-bacterial Honey Dressing on the Healing of Split Thickness Skin Graft Donor Site
A Phase 4 study testing medihoney dressing in people with Disorder of Skin Donor Site, run by HaEmek Medical Center, Israel at 1 site in Israel.
Trial summary
The study, "Evaluation of the effect of antibacterial medical honey dressing for healing of implants donor area", is a Phase 4 Study, Prospective, A randomized trial, 3 arms (treatment groups) trial, Open-label, non-controlled, non-randomized, Aims To test the effectiveness of antibacterial medical honey dressing in… Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Disorder of Skin Donor Site
- What is being tested?
- medihoney dressing
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 135 participants
- Where
- 1 siteIsrael
- Study dates
- May 2015to Jan 2020
- Phase
- Phase 4
- Are there results?
- None posted in the registry
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 with a wound on the hip - the implant donor area
- Wound size up to 100 sm²
Who cannot join
- Known sensitivity of the patient to honey
- Pregnant women
- Patients under 18 years
Trial locations and contacts
1 site in 1 country.
About this study
The study, "Evaluation of the effect of antibacterial medical honey dressing for healing of implants donor area", is a Phase 4 Study, Prospective, A randomized trial, 3 arms (treatment groups) trial, Open-label, non-controlled, non-randomized, Aims To test the effectiveness of antibacterial medical honey dressing in the therapy of donor area of implants. In our Research Will participate in 135 new patients over the age of 18, with a wound in the donor area of hip implants, Hospitalized in the Plastic Surgery Unit of the "Haemek" Medical Center. Appropriate patients, who will agree to sign and sign a consent form, be assigned randomly to one of three treatment groups:
- The research group: Medihoney antibacterial wound dressing.
- The control group: Paraffin gauze with saline- The basic treatment in the donor site, accepted the literature.
- Comparison group: Polymem dressing - Common treatment in the donor site in the Plastic Surgery Unit of the "Haemek" Medical Center.
Participants in the three study groups will be performed, each visit, Medical monitoring and examination by a team of medical indices of Plastic Surgery Unit, as is customary. The treatment will be performed, twice a week until recovery and the complete closure of the wound.
Read the detailed description
Study protocol The aim of this study is to evaluate "The effect of anti-bacterial honey dressing on the healing of split thickness skin graft donor site".
Protocol Abstract. The use of skin grafts for wound closure is considered one of the common methods in the field of plastic surgery. Healing of the donor area is secondary, gradual and is a serious problem, Associated with a high percentage of wound infections, Delay in healing, Scars, Pain unpleasant odor and other problems. As of today, there is no ideal treatment to cure the donor area of implants, due to lack of high-quality comparative studies. The use of honey to treat wounds known for centuries in different cultures. Honey has anti-inflammatory and anti-bacterial effect, Debridement ability, and Pain relief. Honey has almost no side effects. Effectiveness of honey in wound healing has been tested in many clinical trials, but most of them and some methodological problems of low quality. Therefore, it is difficult to conclude that the existing information handling guidelines and recommending further clinical research.
The study, "Evaluation of the effect of antibacterial medical honey dressing for healing of implants donor area", is a Phase 4 Study, Prospective, A randomized trial, 3 arms (treatment groups) trial, Open-label, non-controlled, non-randomized, Aims To test the effectiveness of antibacterial medical honey dressing in the therapy of donor area of implants. In our Research Will participate in 135 new patients over the age of 18, with a wound in the donor area of hip implants, Hospitalized in the Plastic Surgery Unit of the "Haemek" Medical Center. Appropriate patients, who will agree to sign and sign a consent form, be assigned randomly to one of three treatment groups:
- The research group: Medihoney antibacterial wound dressing.
- The control group: Paraffin gauze with saline- The basic treatment in the donor site, accepted the literature.
- Comparison group: Polymem dressing - Common treatment in the donor site in the Plastic Surgery Unit of the "Haemek" Medical Center.
Participants in the three study groups will be performed, each visit, Medical monitoring and examination by a team of medical indices of Plastic Surgery Unit, as is customary. The treatment will be performed, twice a week until recovery and the complete closure of the wound.
Research Goals Primary goal Examining the effect of Medihoney antibacterial wound dressing honey on the duration of the donor site area healing, until full recovery and wound closure.
Secondary objectives
- To Evaluatee the effect of Medihoney antibacterial wound dressing on pain intensity donor site.
- . To Evaluatee the effect of Medihoney antibacterial wound dressing on the frequency of infections in donor site.
Tertiary goal
- To evaluate the effect of Medihoney antibacterial wound dressing on the unpleasant odor in the donor site.
- 2. To evaluate the effect of Medihoney antibacterial wound dressing on patient satisfaction from treatment in donor site.
Research Hypothesis Medihoney antibacterial wound dressing will find significantly statistical more effective in comparison with Paraffin gauze with saline dressing and compared with Polymem dressing, In terms of duration of a treatment, Intensity of pain and the prevalence of infection in the donor site.
Treatment regimen First group Immediately after harvesting the skin, the donor site will be covered with a thin layer of Medihoney Antibacterial Wound Gel and Xtrasorb Super Absorbent Dressing will used as secondary dressing. After 24 hours, the dressing will be replaced by Medihoney HCS dressing.
Medihoney HCS dressing will be replace twice a week.
- Conditions
- Disorder of Skin Donor Site
- Being tested
- medihoney dressing
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
medihoney dressingDevice
to evaluate the effect of medihoney dressing on the healing of split thickness skin graft donor site
| Study group | Role | What they receive |
|---|---|---|
| research group | Experimental | Medihoney Dressing Receives: Device: medihoney dressing |
| control group | No intervention | Paraffin gauze with saline Dressing |
| 3. Comparison group | No intervention | Polymem dressing |
What is being measured
The primary outcome is the main question the study is designed to answer.
Examining the effect of Medihoney antibacterial wound dressing honey on the duration of the donor site area healing, until full recovery and wound closure
The Outcome will be assessed by Medical examination and Laboratory Testing
Measured: 25 days
Secondary outcomes (4)
To Evaluatee the effect of Medihoney antibacterial wound dressing on the frequency of infections in donor site.
The Outcome will be assessed by Medical examination and Laboratory Testing
Measured: 25 days
To Evaluatee the effect of Medihoney antibacterial wound dressing on pain intensity donor site.
The Outcome will be assessed by Medical examination and Questionnaire
Measured: 25 days
To evaluate the effect of Medihoney antibacterial wound dressing on the unpleasant odor in the donor site.
The Outcome will be assessed by Medical examination and Questionnaire
Measured: 25 days
To evaluate the effect of Medihoney antibacterial wound dressing on patient satisfaction from treatment in donor site.
The Outcome will be assessed by Medical examination and Questionnaire
Measured: 25 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Mar 2015 (estimated)
- Study startMay 2015
- Primary completionJan 2020 (estimated)
- Study completionJan 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Disorder of Skin Donor SiteStudies of the same condition, open and under way.
- 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 4
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 135 participants (estimated)
Sponsor and investigators
- Lead sponsor
- HaEmek Medical Center, Israel
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Aziz Shufani, MD, Principal investigator, HaEmek Medical Center, Afula
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02400372
- Sponsor's protocol ID
- 0079-14
- Status last verified
- Aug 2019
- First submitted
- 10 Feb 2015
- Last updated
- 16 Aug 2019
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Anti-bacterial Honey Dressing on the Healing of Split Thickness Skin Graft Donor Site
- ClinicalTrials.gov ID
- NCT02400372
- Acronym / sponsor ID
- 0079-14
- Conditions
- Disorder of Skin Donor Site
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 135 participants (estimated)
- Lead sponsor
- HaEmek Medical Center, IsraelUniversity, hospital or other
- Study start
- May 2015
- Primary completion
- Jan 2020 (estimated)
- Study completion
- Jan 2020 (estimated)
- First posted
- 27 Mar 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The study, "Evaluation of the effect of antibacterial medical honey dressing for healing of implants donor area", is a Phase 4 Study, Prospective, A randomized trial, 3 arms (treatment groups) trial, Open-label, non-controlled, non-randomized, Aims To test the effectiveness of antibacterial medical honey dressing in the therapy of donor area of implants. In our Research Will participate in 135 new patients over the age of 18, with a wound in the donor area of hip implants, Hospitalized in the Plastic Surgery Unit of the "Haemek" Medical Center. Appropriate patients, who will agree to sign and sign a consent form, be assigned randomly to one of three treatment groups:
- The research group: Medihoney antibacterial wound dressing.
- The control group: Paraffin gauze with saline- The basic treatment in the donor site, accepted the literature.
- Comparison group: Polymem dressing - Common treatment in the donor site in the Plastic Surgery Unit of the "Haemek" Medical Center.
Participants in the three study groups will be performed, each visit, Medical monitoring and examination by a team of medical indices of Plastic Surgery Unit, as is customary. The treatment will be performed, twice a week until recovery and the complete closure of the wound.
Detailed description
Study protocol The aim of this study is to evaluate "The effect of anti-bacterial honey dressing on the healing of split thickness skin graft donor site".
Protocol Abstract. The use of skin grafts for wound closure is considered one of the common methods in the field of plastic surgery. Healing of the donor area is secondary, gradual and is a serious problem, Associated with a high percentage of wound infections, Delay in healing, Scars, Pain unpleasant odor and other problems. As of today, there is no ideal treatment to cure the donor area of implants, due to lack of high-quality comparative studies. The use of honey to treat wounds known for centuries in different cultures. Honey has anti-inflammatory and anti-bacterial effect, Debridement ability, and Pain relief. Honey has almost no side effects. Effectiveness of honey in wound healing has been tested in many clinical trials, but most of them and some methodological problems of low quality. Therefore, it is difficult to conclude that the existing information handling guidelines and recommending further clinical research.
The study, "Evaluation of the effect of antibacterial medical honey dressing for healing of implants donor area", is a Phase 4 Study, Prospective, A randomized trial, 3 arms (treatment groups) trial, Open-label, non-controlled, non-randomized, Aims To test the effectiveness of antibacterial medical honey dressing in the therapy of donor area of implants. In our Research Will participate in 135 new patients over the age of 18, with a wound in the donor area of hip implants, Hospitalized in the Plastic Surgery Unit of the "Haemek" Medical Center. Appropriate patients, who will agree to sign and sign a consent form, be assigned randomly to one of three treatment groups:
- The research group: Medihoney antibacterial wound dressing.
- The control group: Paraffin gauze with saline- The basic treatment in the donor site, accepted the literature.
- Comparison group: Polymem dressing - Common treatment in the donor site in the Plastic Surgery Unit of the "Haemek" Medical Center.
Participants in the three study groups will be performed, each visit, Medical monitoring and examination by a team of medical indices of Plastic Surgery Unit, as is customary. The treatment will be performed, twice a week until recovery and the complete closure of the wound.
Research Goals Primary goal Examining the effect of Medihoney antibacterial wound dressing honey on the duration of the donor site area healing, until full recovery and wound closure.
Secondary objectives
- To Evaluatee the effect of Medihoney antibacterial wound dressing on pain intensity donor site.
- . To Evaluatee the effect of Medihoney antibacterial wound dressing on the frequency of infections in donor site.
Tertiary goal
- To evaluate the effect of Medihoney antibacterial wound dressing on the unpleasant odor in the donor site.
- 2. To evaluate the effect of Medihoney antibacterial wound dressing on patient satisfaction from treatment in donor site.
Research Hypothesis Medihoney antibacterial wound dressing will find significantly statistical more effective in comparison with Paraffin gauze with saline dressing and compared with Polymem dressing, In terms of duration of a treatment, Intensity of pain and the prevalence of infection in the donor site.
Treatment regimen First group Immediately after harvesting the skin, the donor site will be covered with a thin layer of Medihoney Antibacterial Wound Gel and Xtrasorb Super Absorbent Dressing will used as secondary dressing. After 24 hours, the dressing will be replaced by Medihoney HCS dressing.
Medihoney HCS dressing will be replace twice a week.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| research group | Experimental | Device: medihoney dressingMedihoney Dressing |
| control group | No intervention | –Paraffin gauze with saline Dressing |
| 3. Comparison group | No intervention | –Polymem dressing |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Patients with a wound on the hip - the implant donor area
- Wound size up to 100 sm²
Key exclusion criteria (3 listed)
- Known sensitivity of the patient to honey
- Pregnant women
- Patients under 18 years
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 |
|---|---|---|
| medihoney dressingto evaluate the effect of medihoney dressing on the healing of split thickness skin graft donor site | Device | research group |
Primary outcome
Examining the effect of Medihoney antibacterial wound dressing honey on the duration of the donor site area healing, until full recovery and wound closure
Time frame: 25 days
The Outcome will be assessed by Medical examination and Laboratory Testing
4 secondary outcomes
To Evaluatee the effect of Medihoney antibacterial wound dressing on the frequency of infections in donor site.
Time frame: 25 days
To Evaluatee the effect of Medihoney antibacterial wound dressing on pain intensity donor site.
Time frame: 25 days
To evaluate the effect of Medihoney antibacterial wound dressing on the unpleasant odor in the donor site.
Time frame: 25 days
To evaluate the effect of Medihoney antibacterial wound dressing on patient satisfaction from treatment in donor site.
Time frame: 25 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Aug 2019.
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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.
Aziz Shufani, MD principal investigator
HaEmek Medical Center, Afula
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing medihoney dressing in people with Disorder of Skin Donor Site, run by HaEmek Medical Center, Israel at 1 site in Israel.
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 2 inclusion and 3 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: status not confirmed, as of the sponsor's last update on 16 Aug 2019. 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 Israel. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact gilat Ron avraham (972-52-8495336, gilat_av@clalit.org.il), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Examining the effect of Medihoney antibacterial wound dressing honey on the duration of the donor site area healing, until full recovery and wound closure (time frame: 25 days). 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 16 Aug 2019.