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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

118 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-04-27

Study Completion Date

2023-12-31

Brief Summary

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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

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Detailed Description

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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.

Conditions

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Wound

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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MaxioCel

Microfiber wound dressing

Group Type EXPERIMENTAL

MaxioCel

Intervention Type DEVICE

Microfiber wound dressing

AquaCel Extra

Hydrofiber dressing

Group Type ACTIVE_COMPARATOR

AquaCel Extra

Intervention Type DEVICE

Hydrofiber dressing

Interventions

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AquaCel Extra

Hydrofiber dressing

Intervention Type DEVICE

MaxioCel

Microfiber wound dressing

Intervention Type DEVICE

Other Intervention Names

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Chitosan Wound Dressing

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No