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

Not Applicable

Terminated

Conditions: Necrotic Tissue Removal
Wound Heal

Interventions: Device: Honey Impregnated Dressing

Registration Number: NCT03412929

Lead Sponsor: Medline Industries

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.

Detailed Description: Not available

Recruitment & Eligibility

Status: TERMINATED

Sex: All

Target Recruitment: 8

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

Study & Design

Study Type: INTERVENTIONAL

Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Honey Impregnated Dressing	Honey Impregnated Dressing	Honey Impregnated Dressing

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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.
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.
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.
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.