Treatment of Full-Thickness Wounds: NPWT Combined With Type-I Collagen Based Advanced Skin Substi… (NCT06873867) | Clinical Trial Compass
CompletedNot Applicable
Treatment of Full-Thickness Wounds: NPWT Combined With Type-I Collagen Based Advanced Skin Substitute Versus NPWT Alone
India104 participantsStarted 2025-03-15
Plain-language summary
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.
Who can participate
Age range18 Years – 80 Years
SexALL
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Inclusion criteria
✓. Subjects must be at least 18 years of age or older.
✓. Presence of a full-thickness wound of at least 4 cm² and no more than 100 cm².
✓. 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
✕. The subject must agree to attend the twice-weekly/weekly study visits required by the protocol.
✕. The subject must be willing and able to participate in the informed consent process.
✕. A subject known to have a life expectancy of \<6 months
✕. Wounds with active infection / osteomyelitis requiring systemic antibiotics.
✕. Presence of malignancy in the wound bed.
✕. Patients with uncontrolled diabetes (HbA1c \> 9%).
What they're measuring
1
Percentage Change in Wound Area
Timeframe: 7 weeks
Trial details
NCT IDNCT06873867
SponsorAdichunchanagiri Institute of Medical Sciences, B G Nagara