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临床试验/CTRI/2025/03/082647
CTRI/2025/03/082647尚未招募2 期

comparative study of antimicrobial efficacy of panchavalkal kwatha and povidone iodine for surgical site preparation on the human skin flora

Faculty of Ayurveda Institute of Medical Sciences BHU1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2025年4月1日最近更新:

试验速览

阶段
2 期
状态
尚未招募
发起方
入组人数
60
试验地点
1
主要终点
Erythema

研究概览

简要总结

The skin flora of patients is one of the most important factors in pathogenesis of surgical site infection. There are two type of skin flora-

Resident flora-Represents the organisms that always present on the whole skin surface including those in the deeper parts of the skin such as the ducts of sebaceous and sweat gland follicles. Flora consist predominantly Staph. epidermis, micrococci,diphtheroids

Transient flora- Wider rang of organisms come in contact with the superficial aspect of skin from the environment, another person or from the persons own alimentary tract. Eg.Staphylococcus.aureus , E.coli ,Klebsiella

Microorganisms are found all over the skin surface but species vary with anatomical sites-

Dry Body sites mainly includes forearm,hands,leg and feet. Eg- coagulase negative staphy.epidermis and staphy.horminis.

Moist sites includes skin folds, beneath breast,elbow crease,in between the groin. These are mainly cornybacterium

Sebaceous sites includes head, neck, trunk area where oily substance sebum allows cutibacterium to thrive, some deodex mites and fungus Malasezzia also congregate in the oily.

area of faces

Microbes that exist on the skin are primarily gram positive.

Staphylococcus epidermis is found in 85%- 100% of normal skin.

Staphylococcus aureus is carried by 5%-25% of normal individuals.

Propionibacterium is normal flora in 45%-100%

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
20.00 Year(s) 至 50.00 Year(s)(—)
性别
All

入选标准

  • Patients prepared for elective abdominal surgeries in Department of Prasuti Tantra SSH BHU and Department of Shalya Tantra SSH BHU.

排除标准

  • Patients having skin infection on lower abdominal area Patients having a active untreated STDs Patients having any severe systemic diseases where healing may be compromised Patients having severe anemia Povidone iodine sensitive patients Patient with irregular follow ups.

结局指标

主要结局

Erythema

时间窗: 2 Followup 2 week | FU1 on 3rd day | FU 2 on stitch removal

pruritis

时间窗: 2 Followup 2 week | FU1 on 3rd day | FU 2 on stitch removal

scaliness

时间窗: 2 Followup 2 week | FU1 on 3rd day | FU 2 on stitch removal

pain

时间窗: 2 Followup 2 week | FU1 on 3rd day | FU 2 on stitch removal

oedema

时间窗: 2 Followup 2 week | FU1 on 3rd day | FU 2 on stitch removal

Minimum Inhibition Concentration

时间窗: 2 Followup 2 week | FU1 on 3rd day | FU 2 on stitch removal

Microorganisms growth/Microbial load

时间窗: 2 Followup 2 week | FU1 on 3rd day | FU 2 on stitch removal

Surgical Outcomes

时间窗: 2 Followup 2 week | FU1 on 3rd day | FU 2 on stitch removal

Based on Subjective and Objective criteria and

时间窗: 2 Followup 2 week | FU1 on 3rd day | FU 2 on stitch removal

Laboratory investigations

时间窗: 2 Followup 2 week | FU1 on 3rd day | FU 2 on stitch removal

Skin tolerability

时间窗: 2 Followup 2 week | FU1 on 3rd day | FU 2 on stitch removal

次要结局

  • Decreased microbial load(2followup 2 week)

研究者

发起方
Faculty of Ayurveda Institute of Medical Sciences BHU
申办方类型
Government funding agency
责任方
Principal Investigator
主要研究者

Dr Kumari Sarita

Banaras Hindu University

研究点 (1)

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