A Comparative Analysis in Treatment of Full-Thickness Wounds: NPWT Combined With Type-I Collagen Based Advanced Skin Substitute Versus NPWT Alone
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 104
- 试验地点
- 2
- 主要终点
- Percentage Change in Wound Area
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
- •If the subject has two or more ulcers, they must be separated by at least 2 cm. The largest ulcer satisfying the inclusion and
排除标准
- •will be designated as the target ulcer.
- •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.
- •Exclusion Criteria:
- •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%).
- •Use of immunosuppressive therapy or systemic corticosteroids.
- •Use of other advanced wound care products within the past 30 days
- •Known allergy to fish products or components of HPTC.
- •Pregnant or breastfeeding women.
- •Presence of osteomyelitis or exposed bone, probes to bone or joint capsule on investigator's exam or radiographic evidence.
- •A subject receiving immunosuppressants (including systemic corticosteroids at doses greater than 10 mg of Prednisone per day or equivalent) or cytotoxic chemotherapy.
- •A subject with autoimmune or connective tissue disorders.
- •A subject who participated in a clinical trial involving treatment with an investigational product within the previous 30 days.
结局指标
主要结局
Percentage Change in Wound Area
时间窗: 7 weeks
Percentage change in wound area from week 1 through week 7 measured manually with digital photography
次要结局
- Time to Achieve Complete Wound Closure(7 weeks)
- Mean Number of Application(6 weeks)
- Number of Adverse Events(6 weeks)
- Pain Score on Visual Analog Scale(7 weeks)
- Healed Wound Appearance Assessment Using Vancouver Scar Scale(7 weeks)
- Quality of Life Assessment(7 weeks)
- Histopathological Analysis on Day 5 of Study(5 days)
- Histopathological Analysis on Day 5 of Study - Capillary Density(5 days)
- Percentage of Participants to Obtain Complete Wound Closure(7 weeks)
- Percentage of Participants Achieving ≥50% Wound Healing(7 weeks)
研究者
Dr Naveen Narayan MS, MCh (Plastic Surgery)
Professor & HoD, Department of Plastic Reconstructive & Aesthetic Surgery
Adichunchanagiri Institute of Medical Sciences, B G Nagara