NCT01547325撤回不适用
Double-Blind, Single-Site, Pilot Study of NanoDOX Hydrogel Versus Placebo Hydrogel for Dehisced Surgical Wounds.
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 试验地点
- 1
- 主要终点
- The rate of 100% wound closure during the 8-week study
研究概览
简要总结
The purpose of this study is to determine the effects of NanoDOX Hydrogel versus Placebo Hydrogel on Dehisced Surgical Wounds.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Be 18 years of age or older
- •Women of childbearing potential must have a negative urine pregnancy test at screening and at baseline, and:
- •Agree to use a double-barrier method of contraception during their participation in this study;
- •condoms (with spermicide) and hormonal contraceptives OR
- •condoms (with spermicide) and intrauterine device OR
- •intrauterine device and hormonal contraceptives OR
- •Abstains from sexual intercourse during their participation in this study OR
- •Is with a same-sex partner and does not participate in bisexual activities where there is a risk of becoming pregnant
- •Have a full-thickness dehisced surgical wound that is between 1.2cm2 and 4 cm2 at initial screening
- •Be able to apply study drug to their wound, or have a reliable and capable caregiver do it
- •Subjects will have adequate blood flow to the wound as defined by transcutaneous oxygen tension (TcpO2) of >30mmHg recorded over intact epidermis at the dehisced surgical wound margin
- •Non-infected (Quantitative bacterial count of < 1.0 x 105 cfu)
排除标准
- •Less than 18 years of age
- •Pregnant or lactating woman or a female of childbearing potential who is not practicing acceptable form of birth control
- •Allergic to tetracycline, minocycline, demeclocycline, or any other known tetracycline derivative
- •Tested positive for a doxycycline-resistant infection
- •Have undergone treatment with system corticosteroid or immunosuppressive therapy in the past 2 months
- •Currently undergoing dialysis for renal failure
- •Have participated in another clinical research trial within the last 30 days
- •Subject has wounds resulting from any cause other than surgical intervention (diabetes, electrical burn, arterial insufficiency, chemical or radiation insult)
- •Active or previous (within 60 days prior to the study screening visit) chemotherapy
- •Active or previous (within 60 days prior to the study screening visit) radiation to the affected wound area to be treated by investigational drug or placebo
- •Physical or mental disability or geographical concerns (residence not within reasonable travel distance) that would hamper compliance with required study visits
- •The Investigator believes that the subject will be unwilling or unable to comply with study protocol requirements standard-of-care self-care requirements, and all study-related follow up visit requirements
- •History of sickle cell anemia
- •History of infection with Human Immunodeficiency Virus
- •History of other immunodeficiency disorders
- •Severe anemia - Hgb < 10 g/dL (males) or < 9 g/dL (females)
- •Severe malnutrition (Albumin < 3.0 gm/dl; > 10% weight loss in preceding 6 weeks)
- •Subjects that the Investigators deems unstable and/or require intensive monitoring
研究组 & 干预措施
NanoDOX Hydrogel
Experimental
干预措施: NanoDOX 1% doxycycline monohydrate Hydrogel (Drug)
Placebo Hydrogel
Placebo Comparator
干预措施: placebo hydrogel (Drug)
结局指标
主要结局
The rate of 100% wound closure during the 8-week study
时间窗: subjects will be followed during their participation in the study for an average of 8 weeks
次要结局
- Safety endpoint(subjects will be followed during their participatoni in the study for an average of 8 weeks)
研究者
研究点 (1)
Loading locations...
相似试验
撤回
2 期
Open Label Trial of NanoDOX Hydrogel in Orthopedic Trauma Wounds With and Without Vacuum Assisted Closure TherapyOrthopedic Trauma WoundsNCT01518491NanoSHIFT LLC
已完成
3 期
A Study of Duloxetine (LY248686) in Japanese Children and Adolescents With Depressive DisorderDepressive DisorderNCT03315793Shionogi149
已完成
3 期
A Study in the Treatment of Children and Adolescents With Major Depressive DisorderMajor Depressive DisorderNCT00849901Eli Lilly and Company337
已完成
3 期
A Study in the Treatment of Children and Adolescents With Major Depressive DisorderMajor Depressive DisorderNCT00849693Eli Lilly and Company463
进行中（未招募）
1 期
A study to determine the safety and efficacy of duloxetine in the treatment of children and adolescents with depression.MedDRA version: 20.0Level: LLTClassification code 10025454Term: Major depressive disorder, recurrent episodeSystem Organ Class: 100000004873Major Depressive DisorderEUCTR2017-001598-18-Outside-EU/EEAEli Lilly and Company Limited463