MedPath

Manuka Honey for Wound Care

Phase 4
Terminated
Conditions
Wound Healing
Interventions
Other: Manuka Honey Dressing
Registration Number
NCT02259491
Lead Sponsor
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.'

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.

Recruitment & Eligibility

Status
TERMINATED
Sex
All
Target Recruitment
10
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

Study & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Arm && Interventions
GroupInterventionDescription
Manuka Honey DressingManuka Honey DressingPatient receive manuka honey dressings on skin graft and free flap donor sites
Primary Outcome Measures
NameTimeMethod
Scar Scaleup to 7 days

Physician assessment of scar by Modified Vancouver Scar Scale

Secondary Outcome Measures
NameTimeMethod
Pain scoresup to 7 days

Assessed by standardized and validated post-operative pain scores

Trial Locations

Locations (1)

Icahn School of Medicine at Mount Sinai

🇺🇸

New York, New York, United States

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