Efficacy and Safety of a Carbopol® 940 Hydrogel Functionalized With Plasma-Activated Water (PAW) in the Treatment of Chronic Wounds: A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Rate of Wound Area Reduction
研究概览
简要总结
The goal of this randomized controlled trial is to evaluate the efficacy and safety of a novel hydrogel made of Carbopol® 940 functionalized with Plasma-Activated Water (PAW) in patients with chronic wounds (diabetic foot ulcers, pressure injuries, dehiscent wounds, arterial and venous ulcers). The main questions it aims to answer are:
- Does PAW-hydrogel accelerate wound closure (reduction in surface area) compared to standard advanced wound care?
- Does PAW-hydrogel reduce bacterial load in the wound bed?
- Is PAW-hydrogel safe and well-tolerated (local adverse events, pain)?
Participants will be randomly assigned to one of two groups:
- Experimental group: Topical application of PAW-hydrogel (Carbopol® 940 neutralized to pH 5.5, loaded with reactive oxygen and nitrogen species from plasma activation) 2-3 times per week.
- Control group: Standard advanced wound care (cleaning, debridement, conventional dressings).
Wound area (planimetry), bacterial load (semi-quantitative cultures), pain (Visual Analog Scale), tissue quality (Bates-Jensen scale), and adverse events will be assessed over a 12-week follow-up period.
详细描述
This prospective, randomized, controlled, parallel-group trial will be conducted at the Wound Clinic and hospitalization services of the Centro Médico ISSEMYM Lic. Arturo Montiel Rojas (Metepec, State of Mexico, Mexico), in collaboration with the Instituto Nacional de Investigaciones Nucleares (ININ), which develops and characterizes the Plasma-Activated Water (PAW) and the functionalized hydrogel.
Adult patients (≥18 years) with chronic wounds of various etiologies - diabetic foot ulcers (Wagner grade 1-2), pressure injuries (grade I-III), dehiscent surgical wounds, venous ulcers, or arterial ulcers - that have failed to heal for more than 3 months and have a surface area between 2 cm² and 20 cm² will be screened. Eligible patients will be randomly allocated (1:1) to either the experimental group (PAW-hydrogel) or the active comparator group (standard advanced wound care). Randomization will be performed using a computer-generated sequence with opaque sealed envelopes.
The PAW-hydrogel intervention consists of a 1% w/v Carbopol® 940 hydrogel neutralized to pH 5.5 and functionalized with PAW generated by a dielectric barrier discharge (DBD) coaxial reactor. The hydrogel is produced under aseptic conditions at ININ, and each batch is tested for pH (5.5) and sterility before release. In the experimental arm, after standard wound cleaning with sterile saline, a uniform layer (3-5 mm thickness) of PAW-hydrogel is applied to cover the entire wound bed, followed by a sterile secondary occlusive dressing. The hydrogel is reapplied 2-3 times per week depending on exudate levels (more frequent for heavily exuding wounds). The control arm receives standard advanced wound care according to ISSEMYM protocols, which includes cleaning, mechanical debridement if needed, and application of conventional dressings (e.g., alginate, foam, or silver-based dressings as clinically indicated), without PAW-hydrogel.
The study is conducted in full compliance with the Declaration of Helsinki and Mexican health regulations (Ley General de Salud). The protocol, informed consent form, and all patient-facing materials have been approved by the Health Research and Research Ethics Committee of ISSEMYM (314/26). All participants provide written informed consent prior to any study procedure. Participants may withdraw at any time without affecting their medical care at ISSEMYM. Data confidentiality is ensured by coding patient identifiers.
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
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adults ≥ 18 years of age.
- •Diagnosis of chronic wound (diabetic foot ulcer Wagner grade 1-2, pressure injury grade I-III, dehiscent surgical wound, venous or arterial ulcer) with duration > 3 months.
- •Wound surface area between 2 cm² and 20 cm².
- •For diabetic patients: HbA1c < 9% (stable metabolic control).
- •Able and willing to provide written informed consent.
排除标准
- •Clinical or radiological evidence of osteomyelitis (Wagner grade > 3).
- •Severe arterial insufficiency (ankle-brachial index < 0.5).
- •Use of systemic corticosteroids or immunosuppressants.
- •Pregnancy or lactation.
- •Known autoimmune skin disease (e.g., pemphigus, epidermolysis bullosa).
- •Active malignancy or undergoing chemotherapy/radiotherapy.
- •Participation in another interventional clinical trial within 30 days prior to screening.
研究组 & 干预措施
PAW-Hydrogel
Participants randomized to this arm will receive topical application of the investigational product: a Carbopol® 940 hydrogel (1% w/v) neutralized to pH 5.5 and functionalized with Plasma-Activated Water (PAW) containing stabilized reactive oxygen and nitrogen species (RONS). At each wound care session (2-3 times per week), the wound bed is first cleaned with sterile saline. A uniform layer of PAW-hydrogel is then applied to cover the entire wound surface, followed by a sterile secondary occlusive dressing. The hydrogel remains in place until the next scheduled dressing change. Treatment continues for up to 12 weeks or until complete wound closure, whichever occurs first.
干预措施: PAW-Functionalized Carbopol® 940 Hydrogel (Device)
Standard Advanced Wound Care
Participants randomized to this arm will receive the institution's current standard advanced wound care protocol for chronic wounds, as routinely practiced at the Centro Médico ISSEMYM Wound Clinic. At each wound care session (2-3 times per week, consistent with the experimental arm), the wound bed is first cleaned with sterile saline, followed by mechanical debridement of devitalized tissue if clinically indicated by the treating clinician. Subsequently, a conventional advanced dressing is selected according to wound characteristics (exudate level, presence of infection, and tissue type) and applied to cover the wound bed, followed by a sterile secondary dressing. The dressing is changed at each scheduled visit. All participants also receive standard concomitant care as per institutional protocols.
干预措施: Standard Advanced Wound Care (Other)
结局指标
主要结局
Rate of Wound Area Reduction
时间窗: From baseline to week 12, measured weekly.
Change in wound surface area (mm²) per week, calculated from digital planimetry (ImageJ) of standardized photographs. Unit of measure: mm²/week.
Change in Bacterial Load
时间窗: Baseline, week 4, week 8, and week 12
Reduction in semi-quantitative colony forming units (CFU) from wound bed swabs or tissue cultures. Unit of measure: CFU/g or semi-quantitative score.
次要结局
- Time to Complete Wound Closure(Up to 12 weeks)
- Change in Pain Intensity(Baseline, each treatment visit (up to 3 times per week), and at week 12.)
- Change in Wound Tissue Quality(Baseline, week 2, week 4, week 8, and week 12.)
- Incidence of Treatment-Related Adverse Events(From first application up to week 12.)
- Number of Dressing Changes Required(From baseline to complete healing or up to 12 weeks.)
研究者
Benjamín Gonzalo Rodríguez Méndez
Principal Investigator
National Institute of Nuclear Research - Mexico