Comparative Study of Negative-Pressure Wound Therapy Integrated With Silver Nanoparticle Spray Versus Negative-Pressure Wound Therapy in Post-Revascularization Diabetic Foot Wound Management
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- time to complete wound healingduring
研究概览
简要总结
This was a prospective, parallel-group, randomized controlled trial conducted at the Vascular Surgery Department of Kafrelsheikh University Hospital, Egypt. The study was approved by the Institutional Review Board and conducted in accordance with the Declaration of Helsinki. Written informed consent was obtained from all participants.
Patients were eligible if they were ≥18 years of age, had diabetes mellitus with critical limb ischemia (CLI) classified as Rutherford category 6 or Fontaine stage IV, and presented with infected or ischemic foot wounds (Wagner grades 2-4) after successful revascularization confirmed by clinical and imaging evaluation. Exclusion criteria included osteomyelitis, active purulent discharge requiring further debridement, known allergy to silver or NPWT components, and inability to attend follow-up.
A total of 100 patients were randomized into two equal groups using a computer-generated list with sealed opaque envelopes. Twelve patients were excluded post-randomization, resulting in 88 patients (44 per group) for final analysis.
Group A received NPWT integrated with silver nanoparticle spray applied for 15 minutes before NPWT application using foam pre-soaked with the same spray. Group B received standard NPWT after saline irrigation. NPWT settings were -125 mmHg, continuous, with dressing changes every 72 hours.
Primary outcome: time to complete epithelialization. Secondary outcomes: wound size reduction, CRP change, infection rate, pain (VAS), hospital stay, reintervention.
Patients were followed weekly for 1 month and then biweekly for 6 months. CRP, WBC, wound measurements, and VAS were assessed at each visit.
SPSS v26 was used for analysis. Shapiro-Wilk test for normality. Independent t-tests and Mann-Whitney U tests for continuous data. Chi-square or Fisher's exact test for categorical variables. Significance at p < 0.05.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 40 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient with critical limb ischemia(CLI) Rutherford stage 6 or Fontaine stage
- •Wounds classified as Wagner classification grade 2 to 4.Successful revascularization was confirmed by imaging and clinical assessment.
排除标准
- •Patients with active infection(pus discharge and still need debridement), osteomyelitis.
- •2. patients who are allergic to silver or any components used in NPWT.
- •patients who are unable to follow up with us. patient
研究组 & 干预措施
two groups A and B groups
A total of 100 patients were randomized into two equal groups using a computer-generated list with sealed opaque envelopes. Twelve patients were excluded post-randomization, resulting in 88 patients (44 per group) for final analysis.
Group A received NPWT integrated with silver nanoparticle spray applied for 15 minutes before NPWT application using foam pre-soaked with the same spray. Group B received standard NPWT after saline irrigation. NPWT settings were -125 mmHg, continuous, with dressing changes every 72 hours.
干预措施: Silver Nanoparticles Irrigant (Drug)
结局指标
主要结局
time to complete wound healingduring
时间窗: during 1 year follow up period
次要结局
未报告次要终点
研究者
Mohab Mohamed Abdelfattah Saeed
Lecturer
Kafrelsheikh University