Health Condition 1: L088- Other specified local infections of the skin and subcutaneous tissue Health Condition 2: L581- Chronic radiodermatitis Health Condition 3: L99- Other disorders of skin and subcutaneous tissue in diseases classified elsewhere
Conditions
Interventions
Intervention1: Cocoheal Ag+: Cocoheal Ag+ is bio-cellulose based antimicrobial occlusive wound dressing with silver
Dose: One sterile dressing of appropriate wound size (approx. 5 5 cm or as per wou
Sponsors
Mr K Vivekanand
Biotechnology Industry Research Assistance Council
Coconut Development Board Kochi
Eligibility
Inclusion criteria
Inclusion criteria: Part A Healthy Subjects Male or Female participants 18to55 years General good health without any clinically significant disease Willingness to provide written informed consent and adhere to protocol requirements PART B and C Patients with Diabetic or Chronic wounds Male or Female patients aged 18to70 years Presence of infected high to moderately exuding wounds Wound types: Diabetic foot ulcers Venous ulcers Pressure ulcers Abrasions or other skin breaks TILI Score greater than or equal 5 Wound area between 4 and 100 Square Cm Ability to provide written informed consent PART D Patients with chemotherapy and Radiation induced Burns Male or Female patients aged 18to70 years Presence of superficial burns or radiation dermatitis confirmed to be caused by chemotherapy or radiation therapy Burn area between square Cm Willingness to provide written informed consent and adhere to the study protocol
Exclusion criteria
Exclusion criteria: Subjects who meet the following criteria will be excluded from the study PART A Pregnant or lactating women History of hypersensitivity or allergy to study drugs or any other component of the formulation Subjects who are not willing to given written informed consent Any finding of clinical observation that is interpreted by the physician investigator as a risk to the subjects participation in the study Use of any investigational drug currently or within 30 days prior to study entry PART B C and D Subject has allergy to silver or any wound care products used in the study Treatment with Cocoheal wound dressing or any silver containing dressing or topical drug during the last 4 weeks Subject has third degree burn profuse bleeding Malignancy Collagen vascular disease Sickle cell vasculopathy or pyoderma Gangrenosum origin of wound Subject has untreated Osteomyelitis Presence of dry wound Subject has uncontrolled hyperglycemia HbA1C more than 12 percentage Subject has end stage renal disease requiring dialysis Subject is undergoing active chemotherapy treatment that inhibits wound healing or has identified cancer Subject has any other condition that in the opinion of the investigator makes the subject in appropriate to take part in this study Subject is unwilling or unable to comply with protocol requirements Subject is pregnant or breast feeding
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| This trial compares Cocoheal Ag+ (occlusive wound dressing with siver) with UrgoClean Ag in acute and chronic wounds, the most widely accepted primary endpoint in such wound dressing trials is wound healing effectiveness often measured as time to complete wound closure or percentage reduction in wound area within a set period.Timepoint: 1.Acute wounds Day 3, Day 7, Day 14, Day 21, Day 28 from baseline (with respective visit windows) primary analysis at Day 14 2.Chronic wounds Week 1, Week 2, Week 4, Week 8, Week 12 from baseline (with respective visit windows); primary analysis at Week 4 | — |
Secondary
| Measure | Time frame |
|---|---|
| Proportion of wounds with complete closure (epithelialization). Time to wound closure (days). Percent reduction in wound area at each visit. Incidence of wound infection and use of systemic antibiotics. Pain at wound site (VAS/NRS). Wound exudate level and wound bed quality. Peri-wound skin condition / adverse skin reactions. Number of dressing changes and average wear time. Device-related adverse events and serious adverse events.Timepoint: Acute: Day 3, Day 7, Day 14, Day 21, Day 28 (or until closure) Chronic: Week 1, Week 2, Week 4, Week 8, Week 12 or until closure | — |
Countries
India
Contacts
Public ContactMr M Aravind
Ardor Biomed India Private Limited
Outcome results
None listed