Comparative Study of Negative-Pressure Wound Therapy Integrated With Silver Nanoparticle Spray Versus Negative-Pressure Wound Therapy in Post-Revascularization Diabetic Foot Wound Management

Обзор

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.

Вмешательства

• Препарат After successful revacularization, We will categorize patients into two groups : groups A (The patient's wound will be cleaned and irrigated with silver nanoparticle spray, then we will cover the woun
  After successful revacularization, We will categorize patients into two groups : groups A (The patient's wound will be cleaned and irrigated with silver nanoparticle spray, then we will cover the wound with silver nanoparticle spray for 15 minutes (time needed for its absorption) before applying NPWT with foam soaked in silver nanoparticle spray) and group B (The patient's wounds will be cleaned and irrigated with a normal saline solution for 15 minutes before applying NPWT.). Standard NPWT set
• Препарат Silver Nanoparticles Irrigant
  After successful revacularization, We will categorize patients into two groups : groups A (The patient's wound will be cleaned and irrigated with silver nanoparticle spray, then we will cover the wound with silver nanoparticle spray for 15 minutes (time needed for its absorption) before applying NPWT with foam soaked in silver nanoparticle spray) and group B (The patient's wounds will be cleaned and irrigated with a normal saline solution for 15 minutes before applying NPWT.). Standard NPWT set

Первичные конечные точки

• time to complete wound healingduring [Срок оценки: during 1 year follow up period]

Критерии участия

Критерии включения

• Patient with critical limb ischemia(CLI) Rutherford stage 6 or Fontaine stage 4. Wounds classified as Wagner classification grade 2 to 4.Successful revascularization was confirmed by imaging and clinical assessment.

Критерии исключения

\- 1. Patients with active infection(pus discharge and still need debridement), osteomyelitis.

2\. patients who are allergic to silver or any components used in NPWT. 3. patients who are unable to follow up with us. patient

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения

Когортное

Центры проведения

Египет · 1 центр

• Kafr El Shaykh University — Kafr ash Shaykh

Идентификаторы

NCT: NCT07147790 · KFSIRB200-252 · medical_research@kfs.edu.eg

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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