Medihoney and Santyl for Burn Injuries
| Status: | Terminated |
|---|---|
| Conditions: | Other Indications, Hospital |
| Therapuetic Areas: | Other |
| Healthy: | No |
| Age Range: | Any |
| Updated: | 4/4/2019 |
| Start Date: | March 15, 2014 |
| End Date: | August 18, 2016 |
A Comparison of Medihoney® Gel With Active Leptospermum Honey and Santyl® in the Treatment of Partial Thickness Burns
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®.
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®).
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.
We found this trial at
1
site
Pittsburgh, Pennsylvania 15224
Principal Investigator: Ariel M Aballay, MD
Phone: 412-578-5281
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