Effectiveness of Silk fibroin powder dressing in Superficial surgical site infections(SSI) in post laparotomy wounds when compared to Saline dressings in wound healing.
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
Chandavaram Bhanu Prakash
JAWAHARLAL INSTITUTE OF POSTGRADUATE MEDICAL EDUCATION AND RESEARCH
