Manuka Honey for Wound Care

NCT ID: NCT02259491

Last Updated: 2020-01-10

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE4
• Total Enrollment: 10 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-12-31
• Study Completion Date: 2017-01-12

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.

Conditions

Wound Healing

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Manuka Honey Dressing

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

Group Type: EXPERIMENTAL

Manuka Honey Dressing

Intervention Type: 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.

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

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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.

Intervention Type: OTHER

Other Intervention Names

Medihoney; Calcium algninate dressings; Dermasciences

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Icahn School of Medicine at Mount Sinai

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Joshua Rosenberg, MD

Role: PRINCIPAL_INVESTIGATOR

Icahn School of Medicine at Mount Sinai

Locations

Icahn School of Medicine at Mount Sinai

New York, New York, United States

Countries

United States

Other Identifiers

GCO 13-1507

Identifier Type: -

Identifier Source: org_study_id