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

Axio Biosolutions Pvt. Ltd.118 enrolled

Overview

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

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

118

Conditions

Wound

Interventions

MaxioCelDEVICE

Microfiber wound dressing

AquaCel ExtraDEVICE

Hydrofiber dressing

Eligibility

Sex: ALLMin age: 18 YearsMax age: 80 Years

Medical Language ↔ Plain English

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

Locations (5)

Hycare Super Speciality Hospital

Chennai, Tamil Nadu, India

RECRUITING

Saveetha Medical College Hospital

Chennai, Tamil Nadu, India

RECRUITING

Vijaya hospitals

Chennai, India

RECRUITING