TerminatedNCT03412929Updated Apr 8, 2020Results posted

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

An interventional study of Honey Impregnated Dressing in Wound Heal and Necrotic Tissue Removal, sponsored by Medline Industries. Terminated at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2020-04-08.

Sponsored by Medline Industries · Not applicable, Interventional, and Treatment

Why this study was terminated

Slow enrollment

Phase: Not applicable
Study type: Interventional
Enrollment: 8
Allocation: Not applicable
Ages: 18 Years and older
Sex: All

Study 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.

Conditions studied

Wound Heal
Necrotic Tissue Removal

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Who can participate

Ages eligible: 18 Years and older
Sexes eligible: All
Accepts 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

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

Study design

Phase: Not applicable
Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrollment: 8 participants (actual)

Study arms

Experimental
Honey Impregnated Dressing
Honey Impregnated Dressing
Device: Honey Impregnated Dressing

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.

What researchers measure

Primary outcomes

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.

Secondary outcomes

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.
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.
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.
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.
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.

Results

Posted Mar 20, 2020

Participant flow

Participant flow — Overall Study
Milestone	Honey Impregnated Dressing
Started	8
Completed	5
Not completed	3
Withdrew: Protocol violation	3

Outcome measures

PrimaryChange 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.
Reported as:: Mean · percent of necrotic tissue

Change in Necrotic Tissue
percent of necrotic tissue	Honey Impregnated Dressing
Change in Necrotic Tissue	40 (10 to 70)

SecondaryWound 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.
Reported as:: Count of participants · Participants

Wound Closure
Participants	Honey Impregnated Dressing
Wound Closure	1

SecondaryInfections

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.
Reported as:: Count of participants · Participants

Infections
Participants	Honey Impregnated Dressing
Infections	0

SecondaryOdor

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.
Reported as:: Median · score on a scale

Odor
score on a scale	Honey Impregnated Dressing
Odor Score Initial Visit	1 (1 to 3)
Odor Score Final Visit	1 (0 to 1)

SecondaryPain 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.
Reported as:: Median · score on a scale

Pain Score
score on a scale	Honey Impregnated Dressing
Pain Score Initial Visit	0 (0 to 1)
Pain Score Final Visit	0 (0 to 0)

SecondaryBates-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.
Reported as:: Mean · score on a scale

Bates-Jensen Wound Assessment Tool Score
score on a scale	Honey Impregnated Dressing
BWAT Score Initial Visit	35.4 (29.4 to 41.4)
BWAT Score Final Visit	23.6 (14.5 to 32.7)

Adverse events

Collected over baseline to 4 weeks. Non-serious events are listed at a 0% frequency threshold.

Adverse event summary by group
Group	Deaths	Serious	Other
Honey Impregnated Dressing	0/8 (0%)	0/8 (0%)	2/8 (25%)

Most frequent other events

Most frequent other events
Event	Honey Impregnated Dressing
SwellingVascular disorders	1/8
AbscessInfections and infestations	1/8

Baseline characteristics

Age, Categorical
Age, Categorical(Participants)	Honey Impregnated Dressing
<=18 years	0
Between 18 and 65 years	4
>=65 years	1

Age, Continuous
Age, Continuous(years)	Honey Impregnated Dressing
Mean	56.6 ± 7.7

Sex: Female, Male
Sex: Female, Male(Participants)	Honey Impregnated Dressing
Female	2
Male	3

Race/Ethnicity, Customized
Race/Ethnicity, Customized(Participants)	Honey Impregnated Dressing
White	4
Black	1

Region of Enrollment
Region of Enrollment(participants)	Honey Impregnated Dressing
United States	5

Study locations

1 site

Northern Illinois Foot & Ankle Specialists
Lake In The Hills, Illinois 60156, United States

References and documents

Study documents

Protocol and statistical analysis plan · Oct 17, 2018

Documents are hosted by the registry — open the source record to download them.

Individual participant data

Plan to share: No

Registry details

Key details

Study ID: NCT03412929
Lead sponsor: Medline Industries
Responsible party: Sponsor
First posted: Jan 29, 2018
Start date: Jan 10, 2018
Primary completion: Jan 10, 2019
Completion: May 28, 2019
Results posted: Mar 20, 2020
Last update: Apr 8, 2020

Oversight

Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: Yes

View the source record on ClinicalTrials.gov ↗

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