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临床试验/CTRI/2024/02/063156
CTRI/2024/02/063156尚未招募2 期

Effectiveness of Silk fibroin powder dressing in Superficial surgical site infections(SSI) in post laparotomy wounds when compared to Saline dressings in wound healing.

Jawaharlal Institute of Postgraduate Medical Education Research JIPMER1 个研究点 分布在 1 个国家目标入组 142 人开始时间: 2024年2月27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
142
试验地点
1
主要终点
wound healing time measured by dr. kamal

研究概览

简要总结

EFFECTIVENESS OF SILK FIBROIN DRESSING IN POST LAPAROTOMY PATIENTS SUPERFICIAL SURGICAL SITE INFECTIONS COMPARED TO SALINE

DRESSING IN WOUND HEALING.

PRIMARY PURPOSE : To compare the effectiveness of silk fibroin dressing and normal saline

dressing in wound healing time measured by kamal’s adaptive wound healing score.

BRIEF STUDY HYPOTHESIS :

SSI is defined as the infection that occurs within 30 days of operative procedure

or within a year of implant placement if implant is placed and the infection is

thought to be secondary to surgery. Negative pressure dressing is a new

technique in treating ssi.

Likewise silk fibroin is also emerging methods of treating SSI, proven in some

studies as an effective method to reduce wound healing time and complications

that arise due to SSI. Silk-based biomaterials stand out for its versatility and

natural biocompatibility. They are available as many formats i.e., mats,

sheets,foam,gel, powder. Silk biomaterials have been applied, e.g., in bone,

cartilage, muscular tissue.

Control of the biodegradation rate of the silk hydrogel and its high bioactivity

makes this biomaterial a choice for soft tissue engineering in comparison to other

hydrogel-based formulations, such as polydimethylsiloxane (PDMS) and

agarose(8), that show a negligible degradation due to the lack, in mammalian

tissues, of enzymes able to decompose such materials .

A randomized clinical trial proved that applying silk fibroin decreases both wound

healing time and adverse effects compared to other commercial dressings.

i.e.,100 % healed by 14 days,and 88.6 % with controlled wound dressing

improved in 19 days.

In this study I would like to test efficacy of silk fibroin in regeneration of soft tissue

and wound healing in SSI developed in laparotomy patients

研究设计

研究类型
Interventional
分配方式
Randomized
盲法
Outcome Assessor Blinded

入排标准

年龄范围
18.00 Year(s) 至 75.00 Year(s)(—)
性别
All

入选标准

  • Consenting post midline laparotomy patients with age more than 18 yrs having superficial SSI with wound dehiscence.

排除标准

  • 1.supericial ssi with wound dehiscence of more than 2 weeks duration.
  • 2.surgeries involving implants eg: mesh in incisional hernias.
  • 3.patients receiving chemotherapy ,radiotherapy, immunotherapy ,or completed therapy with in last one month.
  • 4.Hemodynamically un stable patients.
  • 5.patients in sepsis.
  • 6.patients with re-laparotomies.
  • 7.patients who are allergic to silk products 8.patients who are included in other trials.

结局指标

主要结局

wound healing time measured by dr. kamal

时间窗: wound healing time measured by dr. kamal | adaptive wound healing score

adaptive wound healing score

时间窗: wound healing time measured by dr. kamal | adaptive wound healing score

次要结局

  • 1.amount of wound exudate by weighing soaked(gauze pieces using digital scale.)

研究者

发起方
Jawaharlal Institute of Postgraduate Medical Education Research JIPMER
申办方类型
Research institution and hospital
责任方
Principal Investigator
主要研究者

Chandavaram Bhanu Prakash

JAWAHARLAL INSTITUTE OF POSTGRADUATE MEDICAL EDUCATION AND RESEARCH

研究点 (1)

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