Medihoney and Santyl for Burn Injuries

Summary

This study is designed to assess the efficacy of MEDIHONEY® Gel with Active leptospermum honey dressing relative to SANTYL® ointment dressing on time to heal, bacterial growth in the wound, patient satisfaction, and treatment costs in patients with partial thickness burns. The study has four hypotheses:

1. It is hypothesized that MEDIHONEY® Gel with Active leptospermum honey will result in significantly faster wound healing (i.e., fewer days) when compared to SANTYL®.
2. It is hypothesized that MEDIHONEY® Gel with Active leptospermum honey sites will yield significantly fewer positive cultures for Pseudomonas aeruginosa and other bacteria when compared to SANTYL® sites.
3. It is hypothesized that patients will provide significantly higher patient care satisfaction ratings regarding their MEDIHONEY® Gel with Active leptospermum honey sites when compared to ratings with regard to their SANTYL® sites.
4. It is hypothesized that treatment costs, across participants, will be significantly lower for MEDIHONEY® Gel with Active leptospermum honey than for SANTYL®.

Conditions

• Burns

Interventions

DEVICE

MEDIHONEY® GEL WITH ACTIVE LEPTOSPERMUM HONEY

MEDIHONEY® GEL WITH ACTIVE LEPTOSPERMUM HONEY dressing is manufactured by the company Derma Sciences, Inc. and is a moist dressing made of Active Leptospermum Honey (+15) in combination with natural gelling agents. The gelling agents act to maintain the physical integrity and viscosity of the dressing, even in the presence of body heat and fluids. As a percentage of the overall dressing, MEDIHONEY® GEL dressings contains 80% honey. The dressing has a low pH and can help to lower the overall pH of wounds. The dressing also possesses a high osmotic potential, which assists in debridement.

DEVICE

Santyl

SANTYL® Ointment is an FDA-approved sterile enzymatic debriding ointment which contains 250 collagenase units per gram of white petrolatum USP. The enzyme SANTYL® is derived from the fermentation by Clostridium histolyticum. It possesses the unique ability to digest collagen in necrotic tissue. SANTYL® Ointment is indicated for debriding chronic dermal ulcers and severely burned areas.

Sponsors & Collaborators

• Integra LifeSciences Corporation

  collaborator INDUSTRY

• West Virginia University

  collaborator OTHER

• Allegheny Singer Research Institute (also known as Allegheny Health Network Research Institute)

  lead OTHER

Principal Investigators

• Ariel M Aballay, MD · Western Pennsylvania Hospital Burn Center

• Christina L Duncan, PhD · West Virginia University

Study Design

Allocation

NA

Purpose

TREATMENT

Masking

NONE

Model

SINGLE_GROUP

Eligibility

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2014-03-15

Primary Completion

2016-08-18

Completion

2016-08-18

Countries

• United States

Study Locations