To Evaluate the Efficacy and Safety of MaxioCel Versus Aquacel Extra for the Management of Chronic Wounds

Axio Biosolutions

Status: Enrolling

Conditions: Wound

Treatments: Device: AquaCel Extra; Device: MaxioCel

Study type: Interventional

Funder types: Other

Identifiers

NCT05312762

ABSPL/01/2021

Details and patient eligibility

About

The objective of this study is to evaluate the efficacy and safety of MaxioCel vs Aquacel Extra in the management of exuding ulcers/wounds over a period of 4 weeks

Full description

The current study intends to compare the efficacy of the chitosan wound dressing (MaxioCel) with another marketed dressing (Aquacel Extra). MaxioCel is made up of chitosan and Aquacel Extra with carboxymethyl cellulose. Both are polymeric dressings.

Enrollment: 118 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Male or female 18 years old or above (till 80 years)
• Patients who are willing to sign the written informed consent
• Clinically diagnosed with an unhealed or non-healing diabetic foot ulcer / venous ulcer / arterial ulcer / other ulcers / wounds, etc.
• Wound duration between 1 to 24 months
• A target wound area between 1 cm2 and 50 cm2
• Exuding wounds / ulcers

Exclusion criteria

• Known allergy/hypersensitivity to the dressing
• Pregnant women
• Underlying or diagnosed with serious diseases or deemed unsuitable for this clinical study by the study's clinician
• Dry wounds
• Being treated with a high dose of steroids or immunosuppressant therapy or systemic antibiotics
• Presenting a progressive neoplastic lesion treated with radiotherapy or chemotherapy
• Patients who had Deep Vein Thrombosis in the previous 3 months
• Ulcers with clinical signs of infection or erysipelas of the lower limb or biofilm
• Subjects included in clinical study at present or during the past 30 days
• Clinical suspicion of osteomyelitis

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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118 participants in 2 patient groups

MaxioCel

Experimental group

Description:

Microfiber wound dressing

Treatment:

Device: MaxioCel

AquaCel Extra

Active Comparator group

Description:

Hydrofiber dressing

Treatment:

Device: AquaCel Extra