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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
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| MaxioCel | Experimental | Microfiber wound dressing |
|
| AquaCel Extra | Active Comparator | Hydrofiber dressing |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| MaxioCel | Device | Microfiber wound dressing |
|
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| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Shailee Mehta, MSc. | Contact | +919879009940 | clinicalstudy@axiobio.com |
| Name | Affiliation | Role |
|---|---|---|
| Shailee Mehta, MSc | Axio Biosolutions Pvt. Ltd. | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hycare Super Speciality Hospital | Recruiting | Chennai | Tamil Nadu | 600106 | India |
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| ID | Term |
|---|---|
| D014947 | Wounds and Injuries |
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| AquaCel Extra | Device | Hydrofiber dressing |
|
| 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 |
| Saveetha Medical College Hospital | Recruiting | Chennai | Tamil Nadu | 602105 | India |
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| Vijaya hospitals | Recruiting | Chennai | India |
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| Kamineni Hospitals Pvt Ltd | Recruiting | Hyderabad | India |
|
| Yalamanchi hospital and research center vijayawada | Recruiting | Vijayawada | India |
|