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
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|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||10 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Single (Outcomes Assessor)|
|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|
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.
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
- Scar Scale [ Time Frame: up to 7 days ]Physician assessment of scar by Modified Vancouver Scar Scale
- Pain scores [ Time Frame: up to 7 days ]Assessed by standardized and validated post-operative pain scores
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
|United States, New York|
|Icahn School of Medicine at Mount Sinai|
|New York, New York, United States, 10029|
|Principal Investigator:||Joshua Rosenberg, MD||Icahn School of Medicine at Mount Sinai|