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

Medline Industries

Status

Terminated

Conditions

Wound Heal

Necrotic Tissue Removal

Treatments

Device: Honey Impregnated Dressing

Study type

Interventional

Funder types

Industry

Identifiers

NCT03412929

R16-017

Details and patient eligibility

About

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.

Enrollment

8 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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