Manuka Honey for Wound Care

Wound Healing Clinical Trial

Official title:

Honey Dressings for Local Wound Care of Split Thickness Skin Graft and Free Tissue Transfer Donor Sites: A Prospective, Randomized, Controlled Trial.

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02259491
• Other study ID #: GCO 13-1507
• Status: Terminated
• Phase: Phase 4
• Start date: December 2013
• Est. completion date: January 12, 2017

Study information

• Verified date: February 2018
• Source: Icahn School of Medicine at Mount Sinai
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.'

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 10
• Est. completion date: January 12, 2017
• Est. primary completion date: January 12, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Wound Healing
• Wounds and Injuries

Intervention

Other:
• 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.

Locations

Country	Name	City	State
United States	Icahn School of Medicine at Mount Sinai	New York	New York

Sponsors (1)

Lead Sponsor	Collaborator
Icahn School of Medicine at Mount Sinai

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Scar Scale	Physician assessment of scar by Modified Vancouver Scar Scale	up to 7 days
Secondary	Pain scores	Assessed by standardized and validated post-operative pain scores	up to 7 days