To Evaluate the Efficacy and Safety of MaxioCel Versus Aquacel Extra for the Management of Chronic Wounds
- Conditions
- Wound
- Registration Number
- NCT05312762
- Lead Sponsor
- Axio Biosolutions Pvt. Ltd.
- 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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 118
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method Changes in Epithilizing / Granulating Tissues Week 1, Week 2, Week 3, Week 4 measured by % change in Epithelizing and granulating tissues
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
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
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, LargeBates 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
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
Trial Locations
- Locations (5)
Saveetha Medical College Hospital
🇮🇳Chennai, Tamil Nadu, India
Hycare Super Speciality Hospital
🇮🇳Chennai, Tamilnadu, India
Vijaya hospitals
🇮🇳Chennai, India
Kamineni Hospitals Pvt Ltd
🇮🇳Hyderabad, India
Yalamanchi hospital and research center vijayawada
🇮🇳Vijayawada, India
Saveetha Medical College Hospital🇮🇳Chennai, Tamil Nadu, IndiaGowthamContact