Trial Outcomes & Findings for Medihoney and Santyl for Burn Injuries (NCT NCT02250183)

Last Updated: 2019-05-22

Results Overview

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.

Recruitment status

TERMINATED

Study phase

Target enrollment

21 participants

Primary outcome timeframe

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

Results posted on

2019-05-22

Participant Flow

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.

Participant milestones

Participant milestones
Measure	Medihoney & Santyl Each patient received both interventions simultaneously, but on non-contiguous parts of the body (e.g., bilateral lower extremities), 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 other intervention was SANTYL®, an FDA-approved sterile enzymatic debriding ointment which contains 250 collagenase units per gram of white petrolatum USP.
Overall Study STARTED	21
Overall Study COMPLETED	13
Overall Study NOT COMPLETED	8

Reasons for withdrawal

Reasons for withdrawal
Measure	Medihoney & Santyl Each patient received both interventions simultaneously, but on non-contiguous parts of the body (e.g., bilateral lower extremities), 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 other intervention was SANTYL®, an FDA-approved sterile enzymatic debriding ointment which contains 250 collagenase units per gram of white petrolatum USP.
Overall Study Withdrawal by Subject	2
Overall Study Adverse Event	5
Overall Study Lost to Follow-up	1

Baseline Characteristics

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.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Medihoney & Santyl n=19 Participants 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.
Age, Continuous	42.00 years STANDARD_DEVIATION 14.24 • n=5 Participants • 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.
Sex: Female, Male Female	7 Participants n=5 Participants • 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.
Sex: Female, Male Male	12 Participants n=5 Participants • 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.
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=5 Participants • 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.
Ethnicity (NIH/OMB) Not Hispanic or Latino	10 Participants n=5 Participants • 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.
Ethnicity (NIH/OMB) Unknown or Not Reported	9 Participants n=5 Participants • 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.
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants • 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.
Race (NIH/OMB) Asian	0 Participants n=5 Participants • 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.
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants • 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.
Race (NIH/OMB) Black or African American	3 Participants n=5 Participants • 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.
Race (NIH/OMB) White	16 Participants n=5 Participants • 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.
Race (NIH/OMB) More than one race	0 Participants n=5 Participants • 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.
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants • 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.
Region of Enrollment United States	19 participants n=5 Participants • 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.
Cause of Burn Injury Thermal	10 Participants n=5 Participants • 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.
Cause of Burn Injury Scald	5 Participants n=5 Participants • 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.
Cause of Burn Injury Contact	4 Participants n=5 Participants • 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.
Total Body Surface Area Burned	4.75 Total body surface area percentage STANDARD_DEVIATION 4.57 • n=5 Participants • 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.

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 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.

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.

Outcome measures

Outcome measures
Measure	Medihoney & Santyl n=13 Participants Each patient received both interventions (MEDIHONEY® GEL \& SANTYL® Ointment) simultaneously, but on non-contiguous parts of the body that each consisted of partial thickness burn injuries of similar depth. For example, if a patient presented with bilateral second-degree burns to the lower extremities, one leg was treated with MEDIHONEY® GEL with Active leptospermum honey dressing, while the other leg was treated with SANTYL® ointment dressing.	SANTYL n=13 Participants Each patient received both interventions (MEDIHONEY® GEL \& SANTYL® Ointment) simultaneously, but on non-contiguous parts of the body that each consisted of partial thickness burn injuries of similar depth. For example, if a patient presented with bilateral second-degree burns to the lower extremities, one leg was treated with MEDIHONEY® GEL with Active leptospermum honey dressing, while the other leg was treated with SANTYL® ointment dressing. This arm will be SANTYL ® Ointment.
Number of Participants With Presence vs. Absence of Bacteria in Burn Wound Negative Wound Culture	1 participants	1 participants
Number of Participants With Presence vs. Absence of Bacteria in Burn Wound Positive Wound Culture	12 participants	12 participants

OTHER_PRE_SPECIFIED outcome

Timeframe: 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.

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.

Outcome measures

Outcome measures
Measure	Medihoney & Santyl n=14 Participants Each patient received both interventions (MEDIHONEY® GEL \& SANTYL® Ointment) simultaneously, but on non-contiguous parts of the body that each consisted of partial thickness burn injuries of similar depth. For example, if a patient presented with bilateral second-degree burns to the lower extremities, one leg was treated with MEDIHONEY® GEL with Active leptospermum honey dressing, while the other leg was treated with SANTYL® ointment dressing.	SANTYL Each patient received both interventions (MEDIHONEY® GEL \& SANTYL® Ointment) simultaneously, but on non-contiguous parts of the body that each consisted of partial thickness burn injuries of similar depth. For example, if a patient presented with bilateral second-degree burns to the lower extremities, one leg was treated with MEDIHONEY® GEL with Active leptospermum honey dressing, while the other leg was treated with SANTYL® ointment dressing. This arm will be SANTYL ® Ointment.
Patient Satisfaction Questionnaire Score at End of Study Participation MEDIHONEY	30.86 score on a scale Standard Deviation 2.07	—
Patient Satisfaction Questionnaire Score at End of Study Participation SANTYL	28.00 score on a scale Standard Deviation 3.16	—

OTHER_PRE_SPECIFIED outcome

Timeframe: 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.

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.

Outcome measures

Outcome data not reported

Adverse Events

Medihoney

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Santyl

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Medihoney n=21 participants at risk MEDIHONEY® was the target treatment for this arm. However, each patient received both interventions (MEDIHONEY® GEL \& SANTYL® Ointment) simultaneously, but on non-contiguous parts of the body that each consisted of partial thickness burn injuries of similar depth, to control for individual healing factors when comparing the treatments. For example, if a patient presented with bilateral second-degree burns to the lower extremities, one leg was treated with MEDIHONEY® GEL with Active leptospermum honey dressing, while the other leg was treated with SANTYL® ointment dressing.	Santyl n=21 participants at risk SANTYL® was the target treatment for this arm However, each patient received both interventions (MEDIHONEY® GEL \& SANTYL® Ointment) simultaneously, but on non-contiguous parts of the body that each consisted of partial thickness burn injuries of similar depth, to control for individual healing factors when comparing the treatments. For example, if a patient presented with bilateral second-degree burns to the lower extremities, one leg was treated with MEDIHONEY® GEL with Active leptospermum honey dressing, while the other leg was treated with SANTYL® ointment dressing.
Skin and subcutaneous tissue disorders Infection of the burn wound precipitating change in treatment to include prescribed antibiotics	0.00% 0/21 • 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.	4.8% 1/21 • Number of events 1 • 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.

Additional Information

Ariel M. Aballay, MD

Allegheny Health Network-West Penn Hospital Burn Center

Phone: 412-578-1836

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place