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临床试验/CTRI/2024/05/067053
CTRI/2024/05/067053尚未招募4 期

A clinical outcome of using vacuum assisted dressing and conventional saline dressings in management of chronic non healing ulcer - A randomised controlled trial

Aarupadai veedu medical college and hospital1 个研究点 分布在 1 个国家目标入组 66 人开始时间: 2024年5月20日最近更新:

试验速览

阶段
4 期
状态
尚未招募
发起方
入组人数
66
试验地点
1
主要终点
to study the outcome of healing in vacuum assisted dressing over saline dressing in non healing ulcer

研究概览

简要总结

After correction from the IRC&IEC, convenient sampling of patients attending op and ipd services during the study period mentioned, fulfilling the inclusion and exclusion criteria as listed will be recruited for the study, after obtaining informed written consent under the guidance of the guide and co-guide.

The nature, purpose and their roles in the study will be explained in detail, including the information that their non-participation in the study would not affect the quality of their treatment that they are to receive and that they are free to exit the study at any time. After assuring that their responses would remain confidential, an informed written consent for the same shall be obtained from all participants

Data will be collected using a pre-tested semi-structured proforma to collect sociodemographic details about the patients participating in the study.

Patients based on convenience sampling will be divided into group A& group B

Pre operatively in both the groups detailed history will be taken and routine investigations like HB, TC, DC, ESR, RBS, SEROLOGY, ECG, LFT, RFT, PUS C/S will be done.

Wound preparation will be done by removing the dressing from the wound and discarded. Aculture swab for microbiology culture will be taken before the wound irrigation with normal saline.

Surgical debridement will be done and adequate haemostas is will be achieved.

Sterile, open-cell foam dressing will be gently placed into the wound cavity. the site will be then sealed with an adhesive drape ensuring that the drapes covered the foam and the fenestrated tube inside. Drapes should be placed till three to five centimeters of surrounding healthy tissue.

Controlled pressure will be uniformly applied to all tissues on the inner surface of the wound using centralized vacuum pump. The pressure could be delivered either continuous or intermittent type, ranging from 50 to 125 mm hg. The foam dressing will get compressed in response to the negative pressure. The pressure will be applied continuously for the first 48 hours and then changed to continuos or intermittent therapy

Saline dressing daily will be done in control group

After 5 days the vac will be removed and the wound healing rate will be assesed; culture swab for microbiology will be taken

Data will be tabulated, analyased based on statistical tests

Results obtained and conclusions will be drawn

研究设计

研究类型
Interventional
分配方式
Randomized
盲法
None

入排标准

年龄范围
18.00 Year(s) 至 65.00 Year(s)(—)
性别
All

入选标准

  • Patients with non healing ulcer attending opd of AVMC above 18 years Patients with non healing ulcer who volunteer for trial Neuropathic ulcer patients Dehisced wound ulcers with exposed tendons or bone.

排除标准

  • Wounds with complete necrosis of tissue requiring amputation at time of admission to hospital Patients with bleeding disorders Patients with malignant ulcer Patients with untreated osteomyelitis/ unstable fracture within vicinity of the wound Abdominal wounds.

结局指标

主要结局

to study the outcome of healing in vacuum assisted dressing over saline dressing in non healing ulcer

时间窗: Base day of debridement ,weekly (saline), day 5 of npwt ; post ssg / amputation weekly , monthly

次要结局

  • to find out the difference in duration of hospital stay(to find out the rate of non healing ulcers going into amputation.)

研究者

发起方
Aarupadai veedu medical college and hospital
申办方类型
Private medical college
责任方
Principal Investigator
主要研究者

Dr PriyaDharshini

Aarupadai veedu medical college and hospital

研究点 (1)

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