Manuka Honey for Wound Care
Primary Purpose
Wound Healing
Status
Terminated
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Manuka Honey Dressing
Sponsored by
About this trial
This is an interventional treatment trial for Wound Healing focused on measuring Wound Healing, Honey, Skin Grafts, Free tissue transfer
Eligibility Criteria
Inclusion Criteria:
- All patients over the age of 18 undergoing reconstructive surgery with FTT and/or STSG
Exclusion Criteria:
- 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
Sites / Locations
- Icahn School of Medicine at Mount Sinai
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Manuka Honey Dressing
Tegaderm and xeroform gauze
Arm Description
Patient receive manuka honey dressings on skin graft and free flap donor sites
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
Outcomes
Primary Outcome Measures
Scar Scale
Physician assessment of scar by Modified Vancouver Scar Scale
Secondary Outcome Measures
Pain scores
Assessed by standardized and validated post-operative pain scores
Full Information
NCT ID
NCT02259491
First Posted
October 1, 2014
Last Updated
January 7, 2020
Sponsor
Icahn School of Medicine at Mount Sinai
1. Study Identification
Unique Protocol Identification Number
NCT02259491
Brief Title
Manuka Honey for Wound Care
Official Title
Honey Dressings for Local Wound Care of Split Thickness Skin Graft and Free Tissue Transfer Donor Sites: A Prospective, Randomized, Controlled Trial.
Study Type
Interventional
2. Study Status
Record Verification Date
February 2018
Overall Recruitment Status
Terminated
Study Start Date
December 2013 (undefined)
Primary Completion Date
January 12, 2017 (Actual)
Study Completion Date
January 12, 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Icahn School of Medicine at Mount Sinai
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief 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. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Wound Healing
Keywords
Wound Healing, Honey, Skin Grafts, Free tissue transfer
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
10 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Manuka Honey Dressing
Arm Type
Experimental
Arm Description
Patient receive manuka honey dressings on skin graft and free flap donor sites
Arm Title
Tegaderm and xeroform gauze
Arm Type
No Intervention
Arm Description
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
Intervention Type
Other
Intervention Name(s)
Manuka Honey Dressing
Other Intervention Name(s)
Medihoney, Calcium algninate dressings, Dermasciences
Intervention Description
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.
Primary Outcome Measure Information:
Title
Scar Scale
Description
Physician assessment of scar by Modified Vancouver Scar Scale
Time Frame
up to 7 days
Secondary Outcome Measure Information:
Title
Pain scores
Description
Assessed by standardized and validated post-operative pain scores
Time Frame
up to 7 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
All patients over the age of 18 undergoing reconstructive surgery with FTT and/or STSG
Exclusion Criteria:
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Joshua Rosenberg, MD
Organizational Affiliation
Icahn School of Medicine at Mount Sinai
Official's Role
Principal Investigator
Facility Information:
Facility Name
Icahn School of Medicine at Mount Sinai
City
New York
State/Province
New York
ZIP/Postal Code
10029
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Manuka Honey for Wound Care
We'll reach out to this number within 24 hrs