Recruitment was too slow due to strict inclusion criteria.

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®.

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®).

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.

Total enrolled = 21. Only one pediatric participant was enrolled in this study. As an outlier, this participant was removed from all analyses. Another participant had missing data for all baseline measurement. Thus, total analyzed at baseline = 19.

Adverse event data were collected from the time of enrollment until the time of study completion, i.e., when wounds were healed, or study discontinuation due to participant withdrawing from research or experiencing an adverse event. Given expected healing time for these depth of burn wounds, adverse event data were gathered for up to 4 weeks after enrollment across all participants.

Data were collected via physician examination during weekly follow-up clinic or hospital visits at days 7, 14, or 21 or during an unscheduled follow-up clinic visit (for outpatients) prompted by patient concerns (e.g., calling clinic to express concern about wound appearance). Adverse events were recorded in a log and reported to the IRB, per institutional standards.

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.