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Manuka Honey for Wound Care

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ClinicalTrials.gov Identifier: NCT02259491
Recruitment Status : Terminated
First Posted : October 8, 2014
Last Update Posted : February 28, 2018
Sponsor:
Information provided by (Responsible Party):
Icahn School of Medicine at Mount Sinai

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.'


Condition or disease Intervention/treatment Phase
Wound Healing Drug: Manuka Honey Dressing Phase 4

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 10 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
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 Start Date : December 2013
Actual Primary Completion Date : January 12, 2017
Actual Study Completion Date : January 12, 2017

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Manuka Honey Dressing
Patient receive manuka honey dressings on skin graft and free flap donor sites
Drug: Manuka Honey Dressing
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.
Other Names:
  • Medihoney
  • Calcium algninate dressings
  • Dermasciences

No Intervention: Tegaderm and xeroform gauze
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



Primary Outcome Measures :
  1. Scar Scale [ Time Frame: up to 7 days ]
    Physician assessment of scar by Modified Vancouver Scar Scale


Secondary Outcome Measures :
  1. Pain scores [ Time Frame: up to 7 days ]
    Assessed by standardized and validated post-operative pain scores



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02259491


Locations
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United States, New York
Icahn School of Medicine at Mount Sinai
New York, New York, United States, 10029
Sponsors and Collaborators
Icahn School of Medicine at Mount Sinai
Investigators
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Principal Investigator: Joshua Rosenberg, MD Icahn School of Medicine at Mount Sinai

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Responsible Party: Icahn School of Medicine at Mount Sinai
ClinicalTrials.gov Identifier: NCT02259491     History of Changes
Other Study ID Numbers: GCO 13-1507
First Posted: October 8, 2014    Key Record Dates
Last Update Posted: February 28, 2018
Last Verified: February 2018

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Icahn School of Medicine at Mount Sinai:
Wound Healing
Honey
Skin Grafts
Free tissue transfer
Additional relevant MeSH terms:
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Wounds and Injuries