Trial Outcomes & Findings for A Clinical Evaluation of a Honey Impregnated Dressing at Removing Necrotic Tissue From Chronic Wounds (NCT NCT03412929)

Results Overview

The percent change in necrotic tissue will serve as the primary endpoint.

Recruitment status

TERMINATED

Study phase

NA

Target enrollment

8 participants

Primary outcome timeframe

From initial date of application to weekly visits assessed up to 4 weeks.

Results posted on

2020-04-08

Participant Flow

Participant milestones

Participant milestones
Measure	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.
Overall Study STARTED	8
Overall Study COMPLETED	5
Overall Study NOT COMPLETED	3

Reasons for withdrawal

Reasons for withdrawal
Measure	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.
Overall Study Protocol Violation	3

Baseline Characteristics

A Clinical Evaluation of a Honey Impregnated Dressing at Removing Necrotic Tissue From Chronic Wounds

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Honey Impregnated Dressing n=5 Participants 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.
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	4 Participants n=5 Participants
Age, Categorical >=65 years	1 Participants n=5 Participants
Age, Continuous	56.6 years STANDARD_DEVIATION 7.7 • n=5 Participants
Sex: Female, Male Female	2 Participants n=5 Participants
Sex: Female, Male Male	3 Participants n=5 Participants
Race/Ethnicity, Customized White	4 Participants n=5 Participants
Race/Ethnicity, Customized Black	1 Participants n=5 Participants
Region of Enrollment United States	5 participants n=5 Participants

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Honey Impregnated Dressing n=5 Participants 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.
Change in Necrotic Tissue	40 percent of necrotic tissue Interval 10.0 to 70.0

SECONDARY outcome

Timeframe: From initial date of application to weekly visits assessed up to 4 weeks.

Percent of patients with 100% wound closure in each group

Outcome measures

Outcome measures
Measure	Honey Impregnated Dressing n=5 Participants 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.
Wound Closure	1 Participants

SECONDARY outcome

Timeframe: From initial date of application to weekly visits assessed up to 4 weeks.

Number of infections in the wound sites will be recorded.

Outcome measures

Outcome measures
Measure	Honey Impregnated Dressing n=5 Participants 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.
Infections	0 Participants

SECONDARY outcome

Timeframe: 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.

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.

Outcome measures

Outcome measures
Measure	Honey Impregnated Dressing n=5 Participants 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.
Odor Odor Score Initial Visit	1 score on a scale Interval 1.0 to 3.0
Odor Odor Score Final Visit	1 score on a scale Interval 0.0 to 1.0

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Honey Impregnated Dressing n=5 Participants 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.
Pain Score Pain Score Initial Visit	0 score on a scale Interval 0.0 to 1.0
Pain Score Pain Score Final Visit	0 score on a scale Interval 0.0 to 0.0

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Honey Impregnated Dressing n=5 Participants 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.
Bates-Jensen Wound Assessment Tool Score BWAT Score Initial Visit	35.4 score on a scale Interval 29.4 to 41.4
Bates-Jensen Wound Assessment Tool Score BWAT Score Final Visit	23.6 score on a scale Interval 14.5 to 32.7

Adverse Events

Honey Impregnated Dressing

Serious events: 0 serious events

Other events: 2 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Honey Impregnated Dressing n=8 participants at risk 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.
Vascular disorders Swelling	12.5% 1/8 • Number of events 1 • baseline to 4 weeks
Infections and infestations Abscess	12.5% 1/8 • Number of events 1 • baseline to 4 weeks

Additional Information

Stephanie Martynenko

Medline Industries, Inc

Phone: 2242163822

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place