Medihoney and Santyl for Burn Injuries

Burns Clinical Trial

— MSBI  

Official title:

A Comparison of Medihoney® Gel With Active Leptospermum Honey and Santyl® in the Treatment of Partial Thickness Burns

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02250183
• Other study ID #: 13-021
• Status: Terminated
• Phase: N/A
• Start date: March 15, 2014
• Est. completion date: August 18, 2016

Study information

• Verified date: May 2019
• Source: Allegheny Singer Research Institute
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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®.

Description:

Researchers have examined the usefulness of honey as a treatment for a variety of wounds. Molan outlines some of the benefits of honey in the treatment of wounds, such as its effective antibacterial activity, debriding action, anti-inflammatory component, and antioxidant activity. In addition, the acidity of honey may improve wound healing by decreasing the pH of the wound and providing more oxygen, which ultimately helps to regenerate tissue .

Many studies have demonstrated the effectiveness of honey's antibacterial properties. For example, the antibacterial activity of honey has been shown to protect against multi-resistant strains of bacteria including multi-resistant staphylococcus aureus (MRSA) and Pseudomonas aeruginosa. In fact, research suggests that honey may be an effective antibacterial agent for bacteria that were resistant to up to 13 different antibiotics. Related specifically to burn injuries, results from another study indicated that honey may be an effective antibacterial agent and treatment option for burn injuries infected with or at risk for infection with Pseudomonas aeruginosa. Furthermore, unlike other antibiotics used in clinical care, the possibility of developing honey-resistant wound pathogens is rare, even when using high concentrations of honey, according to one study. Results from these studies provide strong evidence for the usefulness of honey's antibacterial activity in the treatment of wounds, including burn injuries.

In addition to its antibacterial properties, honey has been found to promote wound healing in patients with burn injuries. For example, one study compared the effectiveness of a honey dressing to silver sulfadiazene (SSD) on wound healing in 78 child and adult burn patients with first and second degree burns. According to the results from this study, patients treated with honey dressings had a significantly lower average duration of healing (in days) compared to patients treated with SSD. In addition, approximately half of the wounds treated with honey dressings became sterile within seven days while none of the wounds became sterile during this span of time for the patients who were treated with SSD. The authors of this study also reported that 30 of the 37 patients (81%) treated with honey achieved complete recovery (i.e., complete healing two months post-burn injury without scarring or contractures) compared to 15 out of 41 patients (37%) treated with SSD. Another study by Baghel and colleagues using a similar sample found comparable results. In this second study, patients who were treated with honey dressings were found to heal significantly faster, have sterile wounds in less time, and have better overall recoveries (i.e., fewer hypertrophic scars and contractures) when compared to those patients who were treated with SSD.

Another study compared honey and SSD on burn wound healing (i.e., improvement in burn wound size and re-epithelialization) in patients with superficial partial thickness burns. Patients included in this study had similar burns (e.g., second degree burns of similar depth) on comparable burned surface areas (e.g., right hand and left hand). In addition, patients in this study received both treatment options; that is, a patient's right hand was treated with honey while his/her left hand was treated with SSD. Results from this study indicated that the average healing time was significantly shorter for the body surfaces treated with honey. Interestingly, the wounds treated with honey were found to heal approximately two days faster than the wounds treated with SSD. Additionally, cultures of the wounds found that only six patients tested positive for Pseudomonas aeruginosa in the sites that were treated with honey compared to 27 patients in the sites treated with SSD. Two additional patients tested positive for Escherichia coli infection in the wound sites that were treated with SSD. The authors of this study concluded that honey was a more effective treatment for superficial partial thickness burns than SSD.

Taken together, these studies provide preliminary evidence that honey may be an effective treatment option for partial thickness burns, with benefits such as faster wound healing and wound sterilization. In addition, MEDIHONEY® is cleared by the FDA to maintain a moist environment conducive to wound healing. However, studies have yet to explore the generalizability of these findings to samples of patients with burn injuries in the United States, as all the previously cited studies were conducted outside of the United States. In addition, studies thus far have examined the effectiveness of honey as a wound treatment and have failed to evaluate patient care satisfaction with honey as a treatment option and the treatment costs associated with the use of honey in clinical care. These two outcomes can provide valuable insight into the appropriateness and feasibility of using honey in everyday clinical care. Overall, information obtained from this study will yield knowledge on the potential benefits of this product for burn wound treatment compared to standard care (i.e., SANTYL®).

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 21
• Est. completion date: August 18, 2016
• Est. primary completion date: August 18, 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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.

Related Conditions & MeSH terms

• Burns

Intervention

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.
• 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.

Locations

Country	Name	City	State
United States	Western Pennsylvania Hospital Burn Center	Pittsburgh	Pennsylvania

Sponsors (3)

Lead Sponsor	Collaborator
Allegheny Singer Research Institute	Integra LifeSciences Corporation, West Virginia University

Country where clinical trial is conducted

United States, 

References & Publications (8)

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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.

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Patient Satisfaction Questionnaire Score at End of Study Participation	Patients rated their experience separately for MEDIHONEY & SANTYL treatment. Responses were 6-point Likert type ratings across 6 items measuring pain, burn appearance, ease of use, and willingness to recommend that treatment to other patients. Potential score range was 6-36, with higher scores representing greater satisfaction.The mean difference in participant satisfaction for the MEDIHONEY® GEL and SANTYL® ointment treatments was assessed via a within-subject, two-tailed t-test.	7 to 21 days after enrollment, depending on time it takes for burn injury to completely heal or to discontinue study participation
Other	Cost of Treatment (MEDIHONEY vs. SANTYL) Supplies	The total treatment costs for MEDIHONEY® GEL and SANTYL® ointment will be summed across participants. The total number of SANTYL® tubes and MEDIHONEY® GEL patches used will be totaled for each participant, multiplied by cost, and then compared within subjects with a paired samples, t-test.	At the end of treatment, which can last from 7 to 21 days after enrollment
Primary	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	Number of Participants With Presence vs. Absence of Bacteria in Burn Wound	Wound swab culture results will be compared between treatment modalities via a McNemar test, with treatment modality (MEDIHONEY® GEL versus SANTYL® ointment) and outcome (Positive versus Negative wound culture results for presence of Pseudomonas aeruginosa and/or other bacteria) as the independent and dependent variables, respectively. Each participant has two wound cultures, one for MEDIHONEY® GEL and one for SANTYL® ointment.	Day 7 of study