NCT01290978已完成4 期
Prospective, Randomized Comparison of Two Presurgical Skin Antiseptic Preparations and Resultant Surgical Incise Drape Adhesion to Skin
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 22
- 试验地点
- 1
- 主要终点
- Drape Adhesion
研究概览
简要总结
The purpose of this study is to find out if presurgical antiseptic preparations affect how well surgical drapes adhere to skin.
详细描述
Adhesive incise drapes are often used to provide a physical sterile barrier between the surrounding skin and the open wound at the beginning of a surgery. This study sought to determine the effect of presurgical skin antiseptic preparation on the adhesion of various incise drapes to the skin.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Subject is willing to sign the Research Consent form
- •Healthy male or female subjects ages between 18 - 65
- •Subject has agreed to be and appears to be compliant with requirements of the study
- •Subject has a back (the product application site) of sufficient size, free of blemishes to comfortably fit 18 strips of 1/2" x 3" drape samples
- •Subject is willing to have the back clipped or shaved if it has excessive hair
排除标准
- •Sensitivity/allergy to adhesive products (e.g. medical tapes)
- •Sensitivity to the antimicrobial agent iodine, povidone iodine (PVPI), isopropyl alcohol (IPA), or chlorhexidine gluconate (CHG)
- •Allergy to seafood
- •History of psoriasis dermatitis, or any skin condition that might be exacerbated by the action of removing adhesive materials
- •Active dermatitis (rash), sunburn, blemishes, broken skin, cuts, and/or infection on the subject's back
- •History of diabetes
- •Subject is currently pregnant or thinks she may be pregnant or is nursing
- •Subject is receiving steroid-based anti-inflammatory or immunosuppressant drug therapy
- •Subject is taking antihistamine medication
- •Subject has been using moisturizers or other skin contact materials on the test sites for 24 hours prior to the start of the study
- •Subject has a back problem that prohibits him or her from lying face downward for approximately 2 hours
研究组 & 干预措施
ChloraPrep
Active Comparator
Applied ChloraPrep on the application site per manufacturer's instruction
干预措施: ChloraPrep (Drug)
DuraPrep
Active Comparator
Apply DuraPrep to the application site per manufacturer's instruction
干预措施: DuraPrep (Drug)
结局指标
主要结局
Drape Adhesion
时间窗: 30 minutes
The peel force to remove the sample
次要结局
- Skin Assessment on Ioban, ActiGard, Steri-Drape 2 Application Sites Respectively(30 minutes)
研究者
研究点 (1)
Loading locations...
相似试验
已完成
不适用
Comparison of the Effect of Preoperative and Postoperative ESP and PVB on Postoperative Pain in VATSAnesthesiaNerve BlockPain, PostoperativeThoracic Surgery, Video AssistedNCT06488014Ankara University80
Unknown
4 期
Periarticular Injection Versus Popliteal BlockFoot SurgeryAnkle SurgeryNCT04575688Campbell Clinic100
招募中
不适用
Comparison of the efficacy of the preoperative use of dienogest and gonadotropin releasing hormone agonist for endometriosis: A randomized controlled trialendometriosisJPRN-UMIN000006469Obstetrics and Gynecology60
尚未招募
不适用
Pilot Study- Comparing two surgical preparations Chlorhexidine 2% and Chlorhexidine 2% with Benzyol peroxide 5% for reduction of Propionobacterium acnes in the shoulder region.Post-operative shoulder infectionSkin - Other skin conditionsACTRN12615001295538Wellington Hospital Orthopaedic Department50
已完成
3 期
A Comparison of Prasugrel at PCI or Time of Diagnosis of Non-ST Elevation Myocardial InfarctionAcute Coronary SyndromesNCT01015287Eli Lilly and Company4,033