Health Condition 1: T149- Unspecified injury
Conditions
Interventions
Intervention1: High Purity Type-I Collagen based Skin Substitute with Negative Pressure Wound Therapy: In this study arm, wound is covered with High Purity Type-I Collagen (HPTC) based Skin Substitute
Sponsors
Adichunchangiri University
Eligibility
Inclusion criteria
Inclusion criteria: Presence of a full-thickness wound of at least 4 cm and no more than 100 cm . Wound duration of at least 4 weeks but not exceeding 6 months of standard of care prior to the initial screening visit. Adequate vascular supply to the affected area
Exclusion criteria
Exclusion criteria: Wounds with active infection or osteomyelitis requiring systemic antibiotics or Presence of malignancy in the wound bed or patients with uncontrolled diabetes (HbA1c more than 9%) are all excluded
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Percentage reduction in wound area Description: Percentage wound area reduction from week 1 through week 4 measured manually with digital photographyTimepoint: Percentage reduction in wound area Description: Percentage wound area reduction from week 1 through week 4 measured manually with digital photography | — |
Secondary
| Measure | Time frame |
|---|---|
| Infiltration of vascularity in the ulcer bed Description: Infiltration of vascularity in the ulcer bed on day 5 of application. Vascularity assessment will be done using biopsy on Day 0 of application to be compared with Day 5 after application of Type-I Collagen-based Skin Substitute or Human Amnion/Chorion Membrane. Subsequently histopathology of biopsy will be done to look for: (a) increase in number of blood vessels - as percentage change (b) increase in size of blood vessel - as percentage changeTimepoint: Time Frame: 4 weeks;Time to achieve complete wound closure Description: The time to achieve complete wound closure of the target ulcer by the end of 4 weeksTimepoint: Time Frame: 4 weeks;Proportion of subjects to obtain complete closure Description: The proportion of subjects that obtain complete closure over the 4 week treatment periodTimepoint: Time Frame: 4 weeks;Mean time taken for complete epithelialization Description: measurement of mean time taken by the full thickness wound to complete epithelializationTimepoint: Time Frame: 5 weeks;Mean number of repeated application Description: Mean number of repeated applications of the Advanced Skin Substitute & Human Amnion/Chorion Membrane used to obtain wound closureTimepoint: Time Frame: 4 weeks;Incidence of adverse events Description: Incidence of adverse events related to the intervention (e.g., infection, allergic reactions)Timepoint: Time Frame: 4 weeks;Change in Pain Description: Change in pain measured by a Visual Analog Scale with score range from 0 to 10, wherein 0=no pain to 10=severe painTimepoint: Time Frame: 5 weeks;Healed Wound appearance assessment using Manchester Scar Scale Description: The resultant new skin is assessed and documented at each visit using the Manchester Scar Scale assessing colour, finish, contour, distortion & texture with values given from 1 to 4 wherein 1 denotes excellent and 4 means poorTimepoint: Time Frame: 5 weeks | — |
Countries
India
Contacts
Public ContactDr Naveen Narayan
Adichunchanagiri Institute of Medical Sciences
Outcome results
None listed