Wound HealingPhase 4NCT02259491
Manuka Honey for Wound Care
A Phase 4 study testing Manuka Honey Dressing in people with Wound Healing, run by Icahn School of Medicine at Mount Sinai at 1 site in United States.
Trial summary
Since antiquity, honey has been recognized for its healing properties. Literature about the use of medicinal honey for wound care dates back centuries with recent data suggesting its use in patients suffering from burns or pressure ulcers. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Wound Healing
- What is being tested?
- Manuka Honey Dressing
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2013to 12 Jan 2017
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- All patients over the age of 18 undergoing reconstructive surgery with FTT and/or STSG
Who cannot join
- All patients under the age of 18
- Any patients with documented honey allergy
- Patients with documented collagen vascular diseases
- Patients with documented coagulopathy
- Patients with history of prior skin grafting
Trial locations and contacts
1 site in 1 country.
United States1 site
Icahn School of Medicine at Mount Sinai
New York, New York, 10029
About this study
Official title: Honey Dressings for Local Wound Care of Split Thickness Skin Graft and Free Tissue Transfer Donor Sites: A Prospective, Randomized, Controlled Trial.
Since antiquity, honey has been recognized for its healing properties. Literature about the use of medicinal honey for wound care dates back centuries with recent data suggesting its use in patients suffering from burns or pressure ulcers. Research has shown Manuka honey (Leptospermum scoparium) to have significant immune benefits and the ability to influence all phases of wound healing: inflammation, proliferation and remodeling. In addition, numerous clinical studies have identified positive benefits for wound healing. However, there is a lack of prospective, randomized controlled data on the use of honey as a medicinal agent in local wound care and scar healing.
In order to better understand Manuka Honey's ability to aid in healing, the investigators are conducting a randomized, controlled, single-blinded study of patients undergoing reconstructive surgery. This project uses split thickness skin graft and free tissue transfer donor sites as standard wound models to compare the effects of Manuka Honey versus standard wound care therapies. Through the use of standard wound model and objective measurement tools, the investigators hope to better elucidate any benefits of this novel wound care 'technology.'
Read the detailed description
Free tissue transfer (FTT) and split-thickness skin grafting (STSG) are important aspects of head and neck reconstruction. The radial forearm skin flap and fibula osteocutaneous flap are commonly used in head and neck reconstruction. After harvest, closure of these donor sites often requires split thickness skin grafting. The grafting is usually done from the thigh. The grafted free flap donor site along with the STSG donor site is often the source of significant post-operative pain and complications including delayed wound healing, graft loss and infection. There is no consensus in the literature on the best care for these donor sites with surgeons employing a wide variety of surgical dressings for local wound care. There is literature dating back centuries on the use of medicinal honey for wound care, with recent data suggesting its use in patients suffering from burns or pressure ulcers. However, there is a lack of prospective, randomized controlled data on the use of honey as a medicinal agent in local wound care.
- Conditions
- Wound Healing
- Being tested
- Manuka Honey Dressing
- Keywords
- Wound Healing, Honey, Skin Grafts, Free tissue transfer
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Manuka Honey DressingOther
Also called Medihoney, Calcium algninate dressings, Dermasciences
After surgical resection and reconstruction the skin graft donor site (thigh) and the free flap donor site will be dressed with Medihoney surgical dressings. More specifically, a dressing of appropriate size will be applied to the anterior thigh and covered with tegaderm. For the STSG recipient site a Medihoney dressing will cover the skin graft, followed by dry gauze, kerlex and a cast.
| Study group | Role | What they receive |
|---|---|---|
| Manuka Honey Dressing | Experimental | Patient receive manuka honey dressings on skin graft and free flap donor sites Receives: Other: Manuka Honey Dressing |
| Tegaderm and xeroform gauze | No intervention | Patient receive standard wound care on skin graft and free flap donor sites which includes a tegaderm over the STSG site and xeroform gauze covered with dry gauze, kerlex and a cast for the STSG recipient site |
What is being measured
The primary outcome is the main question the study is designed to answer.
Scar Scale
Physician assessment of scar by Modified Vancouver Scar Scale
Measured: up to 7 days
Secondary outcomes (1)
Pain scores
Assessed by standardized and validated post-operative pain scores
Measured: up to 7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Oct 2014 (estimated)
- Study startDec 2013
- Primary completion12 Jan 2017
- Study completion12 Jan 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Wound HealingStudies of the same condition, open and under way.
- More trials run by Icahn School of Medicine at Mount SinaiThe 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Icahn School of Medicine at Mount Sinai
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Joshua Rosenberg, MD, Principal investigator, Icahn School of Medicine at Mount Sinai
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02259491
- Sponsor's protocol ID
- GCO 13-1507
- Status last verified
- Feb 2018
- First submitted
- 1 Oct 2014
- Last updated
- 10 Jan 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Honey Dressings for Local Wound Care of Split Thickness Skin Graft and Free Tissue Transfer Donor Sites: A Prospective, Randomized, Controlled Trial.
- ClinicalTrials.gov ID
- NCT02259491
- Acronym / sponsor ID
- GCO 13-1507
- Conditions
- Wound Healing
- Keywords
- Wound Healing, Honey, Skin Grafts, Free tissue transfer
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Terminated
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Icahn School of Medicine at Mount SinaiUniversity, hospital or other
- Study start
- Dec 2013
- Primary completion
- 12 Jan 2017 (actual)
- Study completion
- 12 Jan 2017 (actual)
- First posted
- 8 Oct 2014 (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.
Since antiquity, honey has been recognized for its healing properties. Literature about the use of medicinal honey for wound care dates back centuries with recent data suggesting its use in patients suffering from burns or pressure ulcers. Research has shown Manuka honey (Leptospermum scoparium) to have significant immune benefits and the ability to influence all phases of wound healing: inflammation, proliferation and remodeling. In addition, numerous clinical studies have identified positive benefits for wound healing. However, there is a lack of prospective, randomized controlled data on the use of honey as a medicinal agent in local wound care and scar healing.
In order to better understand Manuka Honey's ability to aid in healing, the investigators are conducting a randomized, controlled, single-blinded study of patients undergoing reconstructive surgery. This project uses split thickness skin graft and free tissue transfer donor sites as standard wound models to compare the effects of Manuka Honey versus standard wound care therapies. Through the use of standard wound model and objective measurement tools, the investigators hope to better elucidate any benefits of this novel wound care 'technology.'
Detailed description
Free tissue transfer (FTT) and split-thickness skin grafting (STSG) are important aspects of head and neck reconstruction. The radial forearm skin flap and fibula osteocutaneous flap are commonly used in head and neck reconstruction. After harvest, closure of these donor sites often requires split thickness skin grafting. The grafting is usually done from the thigh. The grafted free flap donor site along with the STSG donor site is often the source of significant post-operative pain and complications including delayed wound healing, graft loss and infection. There is no consensus in the literature on the best care for these donor sites with surgeons employing a wide variety of surgical dressings for local wound care. There is literature dating back centuries on the use of medicinal honey for wound care, with recent data suggesting its use in patients suffering from burns or pressure ulcers. However, there is a lack of prospective, randomized controlled data on the use of honey as a medicinal agent in local wound care.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Manuka Honey Dressing | Experimental | Other: Manuka Honey DressingPatient receive manuka honey dressings on skin graft and free flap donor sites |
| Tegaderm and xeroform gauze | No intervention | –Patient receive standard wound care on skin graft and free flap donor sites which includes a tegaderm over the STSG site and xeroform gauze covered with dry gauze, kerlex and a cast for the STSG recipient site |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- All patients over the age of 18 undergoing reconstructive surgery with FTT and/or STSG
Key exclusion criteria (5 listed)
- All patients under the age of 18
- Any patients with documented honey allergy
- Patients with documented collagen vascular diseases
- Patients with documented coagulopathy
- Patients with history of prior skin grafting
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 |
|---|---|---|
| Manuka Honey DressingAlso: Medihoney, Calcium algninate dressings, DermasciencesAfter surgical resection and reconstruction the skin graft donor site (thigh) and the free flap donor site will be dressed with Medihoney surgical dressings. More specifically, a dressing of appropriate size will be applied to the anterior thigh and covered with tegaderm. For the STSG recipient site a Medihoney dressing will cover the skin graft, followed by dry gauze, kerlex and a cast. | Other | Manuka Honey Dressing |
Primary outcome
Scar Scale
Time frame: up to 7 days
Physician assessment of scar by Modified Vancouver Scar Scale
1 secondary outcome
Pain scores
Time frame: up to 7 days
Results and safety
The study was stopped early. Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jan 2020.
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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.
Joshua Rosenberg, MD principal investigator
Icahn School of Medicine at Mount Sinai
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 Manuka Honey Dressing in people with Wound Healing, run by Icahn School of Medicine at Mount Sinai 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 1 inclusion and 5 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 10 Jan 2020. 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.
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?
The study was stopped early. Results are not available in the source record.
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?
Scar Scale (time frame: up to 7 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 10 Jan 2020.