Wound
Conditions
Brief summary
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
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.
Interventions
DEVICEMaxioCel
Microfiber wound dressing
DEVICEAquaCel Extra
Hydrofiber dressing
Sponsors
Axio Biosolutions Pvt. Ltd.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Wound Area Measurement | Week 1, Week 2, Week 3, Week 4 | Wound area (cm2) to be recorded at baseline and weekly visits to assess % change in wound area. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Exudate Management | Week 1, Week 2, Week 3, Week 4 | Change in Exudate levels will be evaluated. Exudate levels will be evaluated as per below categories: None, Scant, Small, Moderate, Large |
| Changes in Epithilizing / Granulating Tissues | Week 1, Week 2, Week 3, Week 4 | measured by % change in Epithelizing and granulating tissues |
| Bates Janesen Wound Assessment Score | Week 1, Week 2, Week 3, Week 4 | 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 |
| Pain Management | Week 1, Week 2, Week 3, Week 4 | Changes in pain using Numeric Rating Scale (0-10). 0 means no pain, 10 means severe pain/worst possible pain |
| Clinician opinion related to dressing | Week 4 | 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 |
| Patient opinion related to dressing | Week 4 | 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 |
| Scar Management | Week 4 | Vancouver Scar Scale will be used at the final visit to evaluate the scar formation at wound site. Minimum score - 0; Maximum score - 13 |
Countries
India
Contacts
Primary ContactShailee Mehta, MSc.
Outcome results
None listed