Widely used NPWT has been shown to promote wound healing by applying sub-atmospheric pressure, reducing oedema, and enhancing granulation tissue formation thus enhancing wound healing. However, its efficacy can vary based on wound characteristics and patient factors. High Purity Type-I Collagen (HPTC) based advanced skin substitute has emerged as a potential alternative for wound management, accelerating wound healing through extracellular matrix support. This study aims to compare the efficacy of NPWT combined with HPTC versus NPWT alone in the treatment of full-thickness wounds.
Full-thickness wounds, extending through the dermis and affecting underlying tissues, present significant clinical challenges due to their complexity and prolonged healing times. Traditional treatments include surgical debridement, dressings, and advanced therapies like Negative Pressure Wound Therapy (NPWT). Widely used NPWT has been shown to promote wound healing by applying sub-atmospheric pressure, reducing oedema, and enhancing granulation tissue formation thus enhancing wound healing. However, its efficacy can vary based on wound characteristics and patient factors. High Purity Type-I Collagen (HPTC) based advanced skin substitute has emerged as a potential alternative for wound management, accelerating wound healing through extracellular matrix support. Studies suggest that HPTC promote cellular proliferation and angiogenesis, essential for tissue regeneration. Given the distinct mechanisms of action of NPWT and HPTC, a comparative evaluation is warranted to determine their relative efficacy in treating full-thickness wounds. This study aims to compare the efficacy of NPWT combined with HPTC versus NPWT alone in the treatment of full-thickness wounds.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
104
In this wound care is covering with High Purity Type-I Collagen based Skin Substitute followed by a layer of non-adherent and porous dressing. After 5-7 days, wound examined and procedure is repeated as needed
In this wound care is by application of Negative Pressure Wound Therapy using a standard polyurethane foam. The NPWT will be removed after 5-7 days, wound examined and procedure is repeated as needed
Adichunchanagiri Institute of Medical Sciences
Mandya, Karnataka, India
Percentage Change in Wound Area
Percentage change in wound area from week 1 through week 7 measured manually with digital photography
Time frame: 7 weeks
Histopathological Analysis on Day 5 of Study
Histopathological 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. Histopathology assessed at day 0 and day 5, day 5 reported. Subsequently histopathology of biopsy will be done to look for: vascular infiltration (0-3 scale) - higher score means better, neo-epithelialization (0-3 scale) - higher score means better, fibroblast activity (0-3 scale) - higher score means better, inflammatory response (0-3 scale) - lower score means better and collagen deposition (0-3 scale) - higher score means better
Time frame: 5 days
Histopathological Analysis on Day 5 of Study - Capillary Density
Histopathological 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. Histopathology assessed at day 0 and day 5, day 5 reported. Subsequently histopathology of biopsy will be done to look for capillary density (vessels per mm²) - higher count means better,
Time frame: 5 days
Time to Achieve Complete Wound Closure
The time to achieve complete wound closure of the target ulcer by the end of 7 weeks
Time frame: 7 weeks
Percentage of Participants to Obtain Complete Wound Closure
The percentage of participants that obtain complete wound closure over the 7 weeks (6 weeks treatment period plus 1 week follow up)
Time frame: 7 weeks
Percentage of Participants Achieving ≥50% Wound Healing
Measurement of percentage of participants achieving ≥50% wound healing (epithelialization) assessed at follow up
Time frame: 7 weeks
Mean Number of Application
Mean number of rapplications of the NPWT+HPTC \& NPWT alone used to obtain wound closure
Time frame: 6 weeks
Number of Adverse Events
Number of adverse events related to the intervention (e.g., infection, allergic reactions, NPWT seal issues)
Time frame: 6 weeks
Pain Score on Visual Analog Scale
Pain measured by a Visual Analog Scale with score range from 0 to 10, wherein 0="no pain" to 10="severe pain"
Time frame: 7 weeks
Healed Wound Appearance Assessment Using Vancouver Scar Scale
The resultant new skin is assessed and documented at each visit using the Vancouver Scar Scale, up to 7 weeks, week 7 visit reported, assessing vascularity, pigmentation, pliability and height/thickness with total score ranging from 0 to 13 (lesser the score better the scar)
Time frame: 7 weeks
Quality of Life Assessment
The EuroQol 5-Dimension 5-Level (EQ-5D-5L) instrument is a standardized patient-reported outcome measure assessing overall health-related quality of life. It evaluates five dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Scoring and Ranges: 1. EQ-5D-5L Index Score - Derived from the five dimensions with five levels each (1 = no problems; 5 = extreme problems). The index score range varies by population value set; for most countries the possible scoring range is approximately -0.594 to 1.000. Higher scores indicate better health status (1.000 = full health). 2. EQ Visual Analogue Scale (EQ-VAS) - A self-rated health scale from 0 to 100, where, 0 = the worst health you can imagine, 100 = the best health you can imagine. Higher values reflect better outcomes. Interpretation: Higher scores on both the EQ-5D-5L Index and EQ-VAS represent improved quality of life and a better treatment outcome.
Time frame: 7 weeks
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