Necrotic Tissue Removal, Wound Heal
Conditions
Brief summary
The purpose of this study is to evaluate the effectiveness of a honey-impregnated wound dressing at removing necrotic tissue in subjects with chronic foot or ankle wounds.
Interventions
DEVICEHoney Impregnated Dressing
The investigational product being examined contains 100% Manuka honey and is ideal for difficult to dress wounds. The dressing provides a moist wound environment to help promote autolytic debridement. The dressing is ideal for partial or full thickness wounds with moderate-to-heavy drainage.
Sponsors
Medline Industries
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Male or female at least 18 years of age * Subject has a qualified chronic foot or ankle wound, sized 1cm2 to 25 cm2 for ≥ 4 weeks in duration * Must have necrotic tissue at least 25% of wound area * The wound type matches one of the indicated wounds listed on the product labeling: * Leg ulcers * Pressure ulcers * Diabetic foot ulcers * First and second degree burns * Surgical wounds * Trauma wounds * Subject has adequate circulation as demonstrated by biphasic or triphasic Doppler waveform, consistent with adequate blood flow, within 3 months prior to study enrollment. If monophasic on exam, the non-invasive tests must display Ankle Brachial Index over 0.8 and no worse than mild disease on segmental pressures. * Subject is likely to be compliant with instructions for case, such as following institutional standard of care directions, offloading, and keeping the wound area protected from environmental contaminants * Type I/II diabetic subjects that meet the following criteria: * Random blood glucose is less than 450 mg/dL within 30 days of the screening visit
Exclusion criteria
* Subject has a known sensitivity or allergy to honey based products, bee venom, or other ingredients in product * The subject is breastfeeding, pregnant, or has intentions of becoming pregnant during the course of their study participation * Wound duration ≥ 52 weeks * The subject has a prognosis that indicated unlikely survival past the study period * The subject is currently receiving dialysis * Gangrene is present in the target wound * Patient's wound is infected * The subject's diagnosis indicates third degree burns * The subject has received any treatment prior to study enrollment that may, in the opinion of an Investigator, affect the outcome of the study * In the opinion of an Investigator, the subject is otherwise not suitable for study participation, such as the subject is likely to be non-compliant with study requirements
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Necrotic Tissue | From initial date of application to weekly visits assessed up to 4 weeks. | The percent change in necrotic tissue will serve as the primary endpoint. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Wound Closure | From initial date of application to weekly visits assessed up to 4 weeks. | Percent of patients with 100% wound closure in each group |
| Infections | From initial date of application to weekly visits assessed up to 4 weeks. | Number of infections in the wound sites will be recorded. |
| Odor | The odor score will be recorded at weekly visits over four weeks for each subject. | The odor score will be recorded using a scale of 1-4 with a score of 1 being pleasant odor to 4 being an unpleasant odor. |
| Pain Score | The pain score will be recorded at weekly visits over four weeks for each subject. | The pain score will be recorded with a visual analog scale from 0-10. 0 is interpreted as no pain and 10 is the worst imaginable pain. |
| Bates-Jensen Wound Assessment Tool Score | The BWAT score will be recorded at weekly visits over fours weeks for each subject. | The Bates-Jensen Wound Assessment tool score will be used to assess the wound's status. The Bates-Jensen Wound Assessment tool measures wound status. The wound size score ranges from 0 to 5. The wound depth score ranges from 0 to 5. The wound edge score ranges from 0 to 5. The wound undermining score ranges from 0 to 5. The necrotic tissue type score ranges from 1 to 5. The necrotic tissue amount ranges from 1 to 5. The exudate type score ranges from 1 to 5. The exudate amount score ranges from 1 to 5. The skin color surrounding wound score ranges from 1 to 5. The peripheral tissue edema score ranges from 1 to 5. The peripheral tissue induration score score ranges from 1 to 5. The granulation tissue score ranges from 1 to 5. The epithelialization score ranges from 1 to 5. The total score from these sub-scores added together is used as the total BWAT score. For all sub-score values, a value of 0 or 1 is a better outcome. The minimum total score is 9 and the maximum total score is 65. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Honey Impregnated Dressing Honey Impregnated Dressing
Honey Impregnated Dressing: The investigational product being examined contains 100% Manuka honey and is ideal for difficult to dress wounds. The dressing provides a moist wound environment to help promote autolytic debridement. The dressing is ideal for partial or full thickness wounds with moderate-to-heavy drainage. | 5 |
| Total | 5 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Protocol Violation | 3 |
Baseline characteristics
| Characteristic | Honey Impregnated Dressing |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 1 Participants |
| Age, Categorical Between 18 and 65 years | 4 Participants |
| Age, Continuous | 56.6 years STANDARD_DEVIATION 7.7 |
| Race/Ethnicity, Customized Black | 1 Participants |
| Race/Ethnicity, Customized White | 4 Participants |
| Region of Enrollment United States | 5 participants |
| Sex: Female, Male Female | 2 Participants |
| Sex: Female, Male Male | 3 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 8 |
| other Total, other adverse events | 2 / 8 |
| serious Total, serious adverse events | 0 / 8 |
Outcome results
Primary
Change in Necrotic Tissue
The percent change in necrotic tissue will serve as the primary endpoint.
Time frame: From initial date of application to weekly visits assessed up to 4 weeks.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Honey Impregnated Dressing | Change in Necrotic Tissue | 40 percent of necrotic tissue |
Secondary
Bates-Jensen Wound Assessment Tool Score
The Bates-Jensen Wound Assessment tool score will be used to assess the wound's status. The Bates-Jensen Wound Assessment tool measures wound status. The wound size score ranges from 0 to 5. The wound depth score ranges from 0 to 5. The wound edge score ranges from 0 to 5. The wound undermining score ranges from 0 to 5. The necrotic tissue type score ranges from 1 to 5. The necrotic tissue amount ranges from 1 to 5. The exudate type score ranges from 1 to 5. The exudate amount score ranges from 1 to 5. The skin color surrounding wound score ranges from 1 to 5. The peripheral tissue edema score ranges from 1 to 5. The peripheral tissue induration score score ranges from 1 to 5. The granulation tissue score ranges from 1 to 5. The epithelialization score ranges from 1 to 5. The total score from these sub-scores added together is used as the total BWAT score. For all sub-score values, a value of 0 or 1 is a better outcome. The minimum total score is 9 and the maximum total score is 65.
Time frame: The BWAT score will be recorded at weekly visits over fours weeks for each subject.
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Honey Impregnated Dressing | Bates-Jensen Wound Assessment Tool Score | BWAT Score Initial Visit | 35.4 score on a scale |
| Honey Impregnated Dressing | Bates-Jensen Wound Assessment Tool Score | BWAT Score Final Visit | 23.6 score on a scale |
Secondary
Infections
Number of infections in the wound sites will be recorded.
Time frame: From initial date of application to weekly visits assessed up to 4 weeks.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Honey Impregnated Dressing | Infections | 0 Participants |
Secondary
Odor
The odor score will be recorded using a scale of 1-4 with a score of 1 being pleasant odor to 4 being an unpleasant odor.
Time frame: The odor score will be recorded at weekly visits over four weeks for each subject.
Population: Study staff reported scores of 0 when no odor was detectable.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Honey Impregnated Dressing | Odor | Odor Score Final Visit | 1 score on a scale |
| Honey Impregnated Dressing | Odor | Odor Score Initial Visit | 1 score on a scale |
Secondary
Pain Score
The pain score will be recorded with a visual analog scale from 0-10. 0 is interpreted as no pain and 10 is the worst imaginable pain.
Time frame: The pain score will be recorded at weekly visits over four weeks for each subject.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Honey Impregnated Dressing | Pain Score | Pain Score Initial Visit | 0 score on a scale |
| Honey Impregnated Dressing | Pain Score | Pain Score Final Visit | 0 score on a scale |
Secondary
Wound Closure
Percent of patients with 100% wound closure in each group
Time frame: From initial date of application to weekly visits assessed up to 4 weeks.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Honey Impregnated Dressing | Wound Closure | 1 Participants |