Comparison of Mean Duration of Wound Healing Between Vacuum-Assisted Closure (VAC) and Conventional Dressings for the Treatment of Wounds in Patients
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Duration of Wound Healing
研究概览
简要总结
This randomized controlled trial will compare vacuum-assisted closure (VAC) therapy with conventional wound dressings for the treatment of open contaminated and dirty wounds. The study will be conducted in the Department of General Surgery, Jinnah Postgraduate Medical Centre (JPMC), Karachi. Eligible patients aged 15 to 60 years with open contaminated or dirty wounds measuring 5-10 cm and classified as American Society of Anesthesiologists (ASA) grade I or II will be randomly allocated to either VAC therapy or conventional dressings. The primary outcome will be mean duration of wound healing, measured in days from initiation of the assigned treatment until complete wound healing according to predefined clinical criteria. The study will compare the duration of wound healing between the two treatment groups.
详细描述
This randomized controlled trial is designed to compare the mean duration of wound healing between vacuum-assisted closure (VAC) therapy and conventional wound dressings in patients with open contaminated or dirty wounds.
The study will be conducted in the Department of General Surgery, Jinnah Postgraduate Medical Centre (JPMC), Karachi. Patients aged 15-60 years of either sex with open contaminated or dirty wounds measuring 5-10 cm and classified as ASA grade I or II will be considered for inclusion. Written informed consent will be obtained from all participants before enrollment.
A total of 60 participants will be enrolled and randomly allocated in a 1:1 ratio to two parallel treatment groups. Group A will receive VAC therapy, while Group B will receive conventional wound dressings.
All wounds will be thoroughly irrigated with normal saline, and surgical debridement will be performed when clinically indicated. In Group A, the wound will be covered with polyurethane foam, followed by application of an airtight dressing connected to a negative-pressure system. Intermittent negative pressure of 125 mmHg will be applied using cycles of 45 minutes ON and 15 minutes OFF. VAC dressings will be changed every 48-72 hours.
In Group B, saline-soaked conventional dressings will be applied and changed every 24 hours. Participants in both groups will be assessed for wound healing and wound-related complications during the treatment period.
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
- None
入排标准
- 年龄范围
- 15 Years 至 60 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients having open contaminated and dirty wounds of size 5 - 10cm as per operational definition.
- •Patients between ages 15 to 60 years.
- •Both gender
- •ASA grade I & II
- •Willing to provide written informed consent.
排除标准
- •Patients with wounds having dry eschar, malignancy in wound, untreated osteomyelitis, exposed blood vessels and organs, long term anticoagulant therapy, bleeding disorders and fistula to organ / body cavities. Dermatological disorders like acute dermatitis, fungal infections of perianal region.
- •All the patients presented with exposed bone, tendons or nerve will be excluded from study
- •Pregnant women.
- •Patients on medications, such as corticosteroids, immunosuppressive agents or chemotherapy. All above will be assessed on history and documented medical history.
研究组 & 干预措施
VAC Therapy
Participants will receive vacuum-assisted closure (VAC) therapy for wound management.
干预措施: Vacuum-Assisted Closure (VAC) Therapy Description: (Device)
Conventional Dressing
Participants will receive conventional saline-soaked wound dressings.
干预措施: Conventional Wound Dressing (Other)
结局指标
主要结局
Duration of Wound Healing
时间窗: From initiation of treatment until complete wound healing, up to 2 weeks.
Duration of wound healing, measured in days from initiation of the assigned treatment until complete wound healing according to the predefined clinical criteria. The mean duration in days will be compared between the VAC therapy and conventional dressing groups.
次要结局
- Wound Infection(From initiation of treatment until completion of the 2-week follow-up period.)
- Length of Hospital Stay(During the index hospital admission.)
- Need for Additional Surgical Intervention(From initiation of treatment until completion of the 2-week follow-up period.)
研究者
Syeda Zareen Raza
Asisstant professor
Jinnah Postgraduate Medical Centre