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临床试验/CTRI/2025/07/091415
CTRI/2025/07/091415尚未招募不适用

Exploring the effectiveness of Vacuum-Assisted Closure (VAC) therapy in dermatology: A single-arm prospective interventional study.

Dr E Sushnitha Johnson1 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2025年8月15日最近更新:

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
20
试验地点
1
主要终点
To assess the efficacy of Vacuum-Assisted Closure (VAC) therapy in the management of chronic ulcers.

研究概览

简要总结

After screening, all patients with chronic ulcer will be chosen.

Before starting treatment, detailed history, clinical examination of patients will be done.

The patient will be informed about the treatment given and need for hospital stay during the procedure.

Informed written consent will be taken from each patient.

Data will be collected by a single examiner and recorded in case proforma.

Pus culture was taken from the wound prior to the start of dressing.

The wound is first debrided and irrigated with normal saline, ensuring adequate hemostasis, and the peri-wound skin is dried.

A sterile foam dressing is applied to evenly distribute negative pressure across the entire wound bed.

A Ryle’s tube is placed within the foam and connected to a vacuum pump via suction tube.

The wound is then sealed with an adhesive drape, covering the foam, tubing, and extending 3–5 cm beyond the wound margins to ensure a watertight and airtight seal.

This is followed by gamjee dressing and crepe bandage application.

The dressing is typically changed on the third day.

The negative pressure is maintained at 75 to 125mmHg.

Depending on the wound depth and size, number of vac dressing is decided to a maximum of 4 weeks.

Later the patient was followed up with betadine dressing.

After 4 weeks, digital photographs will be taken and compared with the baseline.

The efficacy of VAC therapy will be assessed by improvement in wound area, circumference, length, width, microbial clearance and presence of granulation tissue.

This measurement will be made by imitoMeasureTMapp, granulation tissue presence will be assessed using visual photographs and microbial clearance by culture reports.

Patient’s assessment of improvement will be recorded by visual analogue scale.

The safety of VAC therapy will be assessed by the side effects associated with the therapy.

研究设计

研究类型
Interventional
分配方式
Na
盲法
None

入排标准

年龄范围
10.00 Year(s) 至 80.00 Year(s)(—)
性别
All

入选标准

  • All chronic ulcers including diabetic foot ulcers, venous ulcers, pyoderma gangrenosum ulcer, livedoid vasculopathy ulcer, vasculitis ulcer, infectious ulcer, traumatic ulcer, trophic ulcers.
  • Ulcers resistant to moist wound dressing, PRP, PRF dressing.

排除标准

  • Malignant ulcer.
  • Presence of necrotic tissue.
  • Pregnant or lactating women.
  • Actively bleeding ulcer.
  • Ulcers with underlying osteomyelitis.
  • Patients with bleeding/ coagulation disorder.

结局指标

主要结局

To assess the efficacy of Vacuum-Assisted Closure (VAC) therapy in the management of chronic ulcers.

时间窗: one year

次要结局

  • To assess the safety of Vacuum-Assisted Closure (VAC) therapy in the management of chronic ulcers.(one year)

研究者

发起方
Dr E Sushnitha Johnson
申办方类型
Other [self]
责任方
Principal Investigator
主要研究者

Dr Sushnitha Johnson

Jawaharlal Nehru Medical College, Belgaum

研究点 (1)

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