Burns
Conditions
Keywords
Medihoney, Santyl, Burns
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. 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®.
Detailed 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®).
Interventions
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® 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
Study design
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Wound Appearance | Daily for 7 to 21 days, depending on time it takes burn injury to completely heal | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Presence vs. Absence of Bacteria in Burn Wound | Day 7 of study | 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. |
Other
| Measure | Time frame | Description |
|---|---|---|
| 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 | 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. |
| Cost of Treatment (MEDIHONEY vs. SANTYL) Supplies | At the end of treatment, which can last from 7 to 21 days after enrollment | 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. |
Countries
United States
Participant flow
Recruitment details
Participants were recruited largely from an outpatient burn care clinic in a hospital in the Northeastern U.S.. Some participants also were recruited during their hospitalization in the hospital's inpatient burn care center. The first participant was enrolled on 03/15/2014; the final participant was enrolled on 08/11/2016.
Participants by arm
| Arm | Count |
|---|---|
| Medihoney & Santyl Each patient received both interventions simultaneously, but on non-contiguous parts of the body (e.g., arm vs. leg), each with partial thickness burns of similar depth. One intervention was MEDIHONEY® GEL WITH ACTIVE LEPTOSPERMUM HONEY, a moist dressing made of Active Leptospermum Honey (+15) in combination with natural gelling agents. 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. The other intervention was SANTYL®, an FDA-approved sterile enzymatic debriding ointment which contains 250 collagenase units per gram of white petrolatum USP. SANTYL® Ointment is indicated for debriding chronic dermal ulcers and severely burned areas. | 19 |
| Total | 19 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Adverse Event | 5 |
| Overall Study | Lost to Follow-up | 1 |
| Overall Study | Withdrawal by Subject | 2 |
Baseline characteristics
| Characteristic | Medihoney & Santyl |
|---|---|
| Age, Continuous | 42.00 years STANDARD_DEVIATION 14.24 |
| Cause of Burn Injury Contact | 4 Participants |
| Cause of Burn Injury Scald | 5 Participants |
| Cause of Burn Injury Thermal | 10 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 10 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 9 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 3 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 16 Participants |
| Region of Enrollment United States | 19 participants |
| Sex: Female, Male Female | 7 Participants |
| Sex: Female, Male Male | 12 Participants |
| Total Body Surface Area Burned | 4.75 Total body surface area percentage STANDARD_DEVIATION 4.57 |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 21 | 0 / 21 |
| other Total, other adverse events | 0 / 21 | 1 / 21 |
| serious Total, serious adverse events | 0 / 21 | 0 / 21 |
Outcome results
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.
Time frame: Daily for 7 to 21 days, depending on time it takes burn injury to completely heal
Population: Each participant received both arms of treatment to control for individual healing factors (thus, this is a single group study). Initial analyses yielded inconclusive agreement on healing time due to low quality of pictures (e.g., lighting, focus) and physician reported difficulty in using still photos in isolation to judge wound healing.
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.
Time frame: Day 7 of study
Population: Each participant received both arms of treatment to control for individual healing factors (thus, this is a single group study \& McNemar test is used). Seven participants had missing wound culture data for one or both treatment conditions.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Medihoney & Santyl | Number of Participants With Presence vs. Absence of Bacteria in Burn Wound | Negative Wound Culture | 1 participants |
| Medihoney & Santyl | Number of Participants With Presence vs. Absence of Bacteria in Burn Wound | Positive Wound Culture | 12 participants |
| SANTYL | Number of Participants With Presence vs. Absence of Bacteria in Burn Wound | Negative Wound Culture | 1 participants |
| SANTYL | Number of Participants With Presence vs. Absence of Bacteria in Burn Wound | Positive Wound Culture | 12 participants |
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.
Time frame: At the end of treatment, which can last from 7 to 21 days after enrollment
Population: We did not analyze these data because we determined later that the values were confounded by multiple uncontrolled factors - i.e., size of the burn, unstandardized patient variation in amount of cream used (as treatment was performed at home). Normalizing values to burn size would not be sufficient to make valid comparison.
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.
Time frame: 7 to 21 days after enrollment, depending on time it takes for burn injury to completely heal or to discontinue study participation
Population: Each participant received both treatment arms (single group study). To reduce bias in results, participants not lost to follow-up were asked to complete this survey, regardless of whether they completed the study or discontinued participation due to withdrawal, need for treatment change, or adverse event. Six participants were missing this measure.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Medihoney & Santyl | Patient Satisfaction Questionnaire Score at End of Study Participation | MEDIHONEY | 30.86 score on a scale | Standard Deviation 2.07 |
| Medihoney & Santyl | Patient Satisfaction Questionnaire Score at End of Study Participation | SANTYL | 28.00 score on a scale | Standard Deviation 3.16 |