Manuka Honey for Wound Care

NCT02259491 | Terminated Phase 4

• 1 other identifier: GCO 13-1507
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

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.'

Conditions

Wound Healing

Keywords

Wound Healing; Honey; Skin Grafts; Free tissue transfer

Outcome Measures

Primary Outcomes (1)

• Scar Scale

  Physician assessment of scar by Modified Vancouver Scar Scale

  up to 7 days

Secondary Outcomes (1)

• Pain scores

  up to 7 days

Study Arms (2)

Manuka Honey Dressing

EXPERIMENTAL

Patient receive manuka honey dressings on skin graft and free flap donor sites

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

Interventions

Manuka Honey Dressing OTHER

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.

Also known as: Medihoney, Calcium algninate dressings, Dermasciences

Manuka Honey Dressing

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• All patients over the age of 18 undergoing reconstructive surgery with FTT and/or STSG

You may not qualify if:

• 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

Sponsors & Collaborators

• Icahn School of Medicine at Mount Sinai: lead

Study Sites (1)

Icahn School of Medicine at Mount Sinai

New York, New York, 10029, United States

Location

Study Officials

• Joshua Rosenberg, MD

  Icahn School of Medicine at Mount Sinai

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 1, 2014
• First Posted: October 8, 2014
• Study Start: December 1, 2013
• Primary Completion: January 12, 2017
• Study Completion: January 12, 2017
• Last Updated: January 10, 2020

Record last verified: 2018-02

Locations

US (1)