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

Study Overview
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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

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.

Official Title
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An Open Label, Multicentre, Randomized Phase IV Clinical Trial to Evaluate the Safety and Efficacy of MaxioCel Compared With Aquacel Extra for the Management of Exuding Chronic Wounds

Conditions
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Wound

Intervention / Treatment
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* Device: MaxioCel
* Device: AquaCel Extra


Participation Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: MaxioCel<br>Microfiber wound dressing | Device: MaxioCel<br>* Microfiber wound dressing<br>* Other names: Chitosan Wound Dressing;|
| Active Comparator: AquaCel Extra<br>Hydrofiber dressing | Device: AquaCel Extra<br>* Hydrofiber dressing<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Wound Area Measurement | Wound area (cm2) to be recorded at baseline and weekly visits to assess % change in wound area. | Week 1, Week 2, Week 3, Week 4 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain Management | Changes in pain using Numeric Rating Scale (0-10). 0 means no pain, 10 means severe pain/worst possible pain | Week 1, Week 2, Week 3, Week 4 | 
| Exudate Management | Change in Exudate levels will be evaluated. Exudate levels will be evaluated as per below categories: None, Scant, Small, Moderate, Large | Week 1, Week 2, Week 3, Week 4 | 
| Changes in Epithilizing / Granulating Tissues | measured by % change in Epithelizing and granulating tissues | Week 1, Week 2, Week 3, Week 4 | 
| Bates Janesen Wound Assessment Score | The status of wound as per 13 items mentioned in the Bates-Jensen Wound Assessment Tool will be evaluated. Higher the total score, the more severe the wound status.Minimum score - 13 ; Maximum score - 65 | Week 1, Week 2, Week 3, Week 4 | 
| Scar Management | Vancouver Scar Scale will be used at the final visit to evaluate the scar formation at wound site. Minimum score - 0; Maximum score - 13 | Week 4 | 
| Clinician opinion related to dressing | Dressing usability / use of dressing will be evaluated via questionnaire. The options for rating will be Excellent, Good, Fair, Poor. For few questions, options will be Yes or No | Week 4 | 
| Patient opinion related to dressing | Patients comfort levels with use of dressing will be evaluated via questionnaire. The options for rating will be Excellent, Good, Fair, Poor. For few questions, options will be Yes or No | Week 4 |