DEVELOPMENT AND EVALUATION OF AN OXYGEN DELIVERY SYSTEM FOR ENHANCED WOUND HEALING IN HOSPITAL WARD SETTINGS
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 100
- 试验地点
- 1
研究概览
简要总结
Chronic and hypoxic wounds are associated with delayed healing, increased risk of infection, and significant healthcare burden. Adequate oxygenation plays a critical role in collagen synthesis, angiogenesis, and bacterial defense, all of which are essential for effective wound repair.
This study is a prospective randomized controlled trial designed to evaluate the efficacy and safety of a continuous topical oxygen delivery sleeve as an adjunct to standard wound care. A total of 100 eligible participants will be randomized into intervention and comparator groups to receive either continuous topical oxygen therapy with standard dressing or standard wound care alone.
Wound healing will be assessed using percentage reduction in wound area measured through digital planimetry over a 12-week follow-up period. Secondary outcomes include early wound healing response, time to complete epithelialization, and feasibility of device use in routine ward settings and potential use in low resource ward setting.
The device is designed to utilize oxygen from existing hospital ward supply systems, enabling potential applicability in resource-constrained and low socioeconomic healthcare settings where access to advanced wound care technologies may be limited.
The findings of this study aim to generate clinical evidence supporting accessible, physiologically targeted, and scalable approaches to wound management.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- None
入排标准
- 年龄范围
- 18.00 Year(s) 至 90.00 Year(s)（—）
- 性别
- All
入选标准
- •Adults aged 18 years and above.
- •Patients with hypoxic wounds of any duration.
- •Swab negative acute surgical wounds.
- •Wound size between 1 cm2 and 20 cm2 after appropriate debridement.
- •Adequate limb perfusion deemed clinically acceptable by the investigator.
- •Wounds suitable for topical therapy without immediate need for surgical closure.
- •Ability and willingness to provide written informed consent.
- •Willingness to comply with study procedures and attend scheduled follow-ups.
排除标准
- •Critical limb ischemia or patients requiring urgent vascular intervention.
- •Malignant wounds.
- •Untreated osteomyelitis or severe soft tissue infection requiring immediate surgical management.
- •Wounds with exposed major blood vessels, nerves, or organs where topical therapy may be unsafe.
- •Severe uncontrolled systemic illness likely to impair wound healing e.g., advanced renal failure, severe hepatic disease, uncontrolled sepsis.
- •Known hypersensitivity to materials used in study dressings.
- •Pregnant or lactating women.
- •Patients currently enrolled in another interventional clinical trial or who have participated in one within the previous 3 months.
- •Any condition which, in the opinion of the investigator, makes the participant unsuitable for inclusion.
研究者
Dwaarakesh M S
Department of general surgery, Saveetha medical college hospital and research centre