Medihoney and Santyl for Burn Injuries

NCT02250183 | Terminated Results

• 1 other identifier: 13-021
• Study Type: interventional
• Target: 21
• Locations: 1 country
• Sites: 1

Brief 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. 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. 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. 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. 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

Keywords

Medihoney; Santyl; Burns

Outcome Measures

Primary Outcomes (1)

• Change in Wound Appearance

  Pictures of wounds and associated "seepage test" paper towels, without indication of date or arm of treatment, were rated by two independent physicians regarding healed or not yet healed. This information was then be used to calculate a "time to heal" variable (# of days) for each patient.

  Daily for 7 to 21 days, depending on time it takes burn injury to completely heal

Secondary Outcomes (1)

• Number of Participants With Presence vs. Absence of Bacteria in Burn Wound

  Day 7 of study

Other Outcomes (2)

• Patient Satisfaction Questionnaire Score at End of Study Participation

  7 to 21 days after enrollment, depending on time it takes for burn injury to completely heal or to discontinue study participation

• Cost of Treatment (MEDIHONEY vs. SANTYL) Supplies

  At the end of treatment, which can last from 7 to 21 days after enrollment

Study Arms (1)

Medihoney & Santyl

OTHER

Each patient will receive both interventions simultaneously, but on non-contiguous parts of the body that each consist of partial thickness burn injuries of similar depth. For example, if a patient presents with bilateral second-degree burns to the lower extremities, one leg will be treated with MEDIHONEY® GEL with Active leptospermum honey dressing, while the other leg will be treated with SANTYL® ointment dressing. MEDIHONEY® is the target treatment for this study, while SANTYL® is standard care.

Device: MEDIHONEY® GEL WITH ACTIVE LEPTOSPERMUM HONEY; Device: Santyl

Interventions

MEDIHONEY® GEL WITH ACTIVE LEPTOSPERMUM HONEY DEVICE

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.

Also known as: Medihoney

Medihoney & Santyl

Santyl DEVICE

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.

Medihoney & Santyl

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• New patient presenting with a partial thickness burn injury in at least two non-contiguous locations of the body.
• Enrollment will occur within 72 hours of sustaining a burn injury.

You may not qualify if:

• Cognitive or language barriers that preclude completion of study measures.
• Have burn injuries exceeding 40% total body surface area (TBSA).
• Have a diagnosis of immunodeficiency or kidney disease.
• Are receiving treatment (e.g., chemotherapy, dialysis) that can create concerns with immunodeficiency or affect healing.
• Are pregnant.

Sponsors & Collaborators

• Allegheny Singer Research Institute (also known as Allegheny Health Network Research Institute): lead
• Integra LifeSciences Corporation: collaborator
• West Virginia University: collaborator

Study Sites (1)

Western Pennsylvania Hospital Burn Center

Pittsburgh, Pennsylvania, 15224, United States

Location

Related Publications (8)

• Molan PC. The evidence and the rationale for the use of honey as a wound dressing. Wound Practice and Research, 19(4): 204-220, 2011.

  BACKGROUND

• Blair SE, Cokcetin NN, Harry EJ, Carter DA. The unusual antibacterial activity of medical-grade Leptospermum honey: antibacterial spectrum, resistance and transcriptome analysis. Eur J Clin Microbiol Infect Dis. 2009 Oct;28(10):1199-208. doi: 10.1007/s10096-009-0763-z. Epub 2009 Jun 10.

  PMID: 19513768 BACKGROUND

• George NM, Cutting KF. Antibacterial Honey (Medihoney): in-vitro Activity Against Clinical Isolates of MRSA, VRE, and Other Multiresistant Gram-negative Organisms Including Pseudomonas aeruginosa. Wounds. 2007 Sep;19(9):231-6.

  PMID: 25942744 BACKGROUND

• Cooper RA, Halas E, Molan PC. The efficacy of honey in inhibiting strains of Pseudomonas aeruginosa from infected burns. J Burn Care Rehabil. 2002 Nov-Dec;23(6):366-70. doi: 10.1097/00004630-200211000-00002.

  PMID: 12432313 BACKGROUND

• Cooper RA, Jenkins L, Henriques AF, Duggan RS, Burton NF. Absence of bacterial resistance to medical-grade manuka honey. Eur J Clin Microbiol Infect Dis. 2010 Oct;29(10):1237-41. doi: 10.1007/s10096-010-0992-1. Epub 2010 Jun 13.

  PMID: 20549529 BACKGROUND

• Gupta SS, Singh O, Bhagel PS, Moses S, Shukla S, Mathur RK. Honey dressing versus silver sulfadiazene dressing for wound healing in burn patients: a retrospective study. J Cutan Aesthet Surg. 2011 Sep;4(3):183-7. doi: 10.4103/0974-2077.91249.

  PMID: 22279383 BACKGROUND

• Baghel PS, Shukla S, Mathur RK, Randa R. A comparative study to evaluate the effect of honey dressing and silver sulfadiazene dressing on wound healing in burn patients. Indian J Plast Surg. 2009 Jul;42(2):176-81. doi: 10.4103/0970-0358.59276.

  PMID: 20368852 BACKGROUND

• Malik KI, Malik MA, Aslam A. Honey compared with silver sulphadiazine in the treatment of superficial partial-thickness burns. Int Wound J. 2010 Oct;7(5):413-7. doi: 10.1111/j.1742-481X.2010.00717.x.

  PMID: 20649832 BACKGROUND

MeSH Terms

Conditions

Burns

Condition Hierarchy (Ancestors)

Wounds and Injuries

Limitations and Caveats

Early termination resulting from strict inclusion criteria reduced sample size for analysis; Technical \& methodological problems in measurement (photos to gauge healing; treatment costs confounded by variation in gel use) led to uninterpretable data.

Results Point of Contact

• Title: Ariel M. Aballay, MD
• Organization: Allegheny Health Network-West Penn Hospital Burn Center

Ariel.Aballay@AHN.org

412-578-1836

Study Officials

• Ariel M Aballay, MD

  Western Pennsylvania Hospital Burn Center

  PRINCIPAL INVESTIGATOR

• Christina L Duncan, PhD

  West Virginia University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Psychology

Study Record Dates

• First Submitted: September 15, 2014
• First Posted: September 26, 2014
• Study Start: March 15, 2014
• Primary Completion: August 18, 2016
• Study Completion: August 18, 2016
• Last Updated: May 22, 2019
• Results First Posted: April 2, 2019

Record last verified: 2019-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)