NCT01081522已完成不适用
A Preliminary, Non-comparative Study to Evaluate a Bioresorbable Wound Scaffold in Acute Wounds
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 12
- 试验地点
- 3
研究概览
简要总结
As this is a proof-of-concept study, the primary objective is to provide preliminary data on the safety and efficacy of Bioresorbable Wound Scaffold in the management of acute wounds left to heal by secondary intent.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
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
- •Subjects over 18 years, willing and able to provide written informed consent.
- •Subjects who have an excised pilonidal sinus wound left to heal by secondary intent.
- •Subjects who are willing to commit to having two biopsies being taken during the study.
排除标准
- •Subjects with a history of skin sensitivity to any of the components of the study product
- •Subjects whose wound is infected
- •Subjects who have participated in a previous clinical study within the past 3 months
- •Subjects' with a known history of poor compliance with medical treatments
- •Subjects who are pregnant (where pregnancy is a possibility, a pregnancy testing kit will be provided)
- •Necrotic/sloughy wounds unless surgically debrided prior to enrolment
- •Medical or emotional risk associated with the potential biopsy that outweighs the risk of not taking a biopsy as determined by the investigator
- •Subjects exhibiting any other medical condition which, according to the Investigator, justifies the subject's exclusion from the study
- •Subjects with impaired renal function
研究者
研究点 (3)
Loading locations...
相似试验
已完成
2 期
A prospective *proof of concept study* to evaluate the potential efficacy of ustekinumab in patients with moderate to severe hidradenitis suppurativa (acne ectopica)acne ectopicaacne inversa10040798hidradenitis suppurativaNL-OMON37989niversitair Medisch Centrum Groningen20
已完成
2 期
Belimumab Treatment of Emphysema Patients With Anti-GRP78 AutoantibodiesEmphysemaChronic Obstructive Pulmonary DiseaseNCT03244059University of Alabama at Birmingham17
已完成
不适用
Neurostimulation Device for Treatment of Migraine HeadacheMigraine HeadacheNCT01630044Scion NeuroStim3
进行中（未招募）
1 期
Study of efficacy and safety of secukinumab 300 mg in adult patients with biopsy-proven forms of lichen planusichen planusMedDRA version: 20.0Level: PTClassification code 10024429Term: Lichen planusSystem Organ Class: 10040785 - Skin and subcutaneous tissue disordersEUCTR2019-003588-24-DEovartis Pharma AG108
进行中（未招募）
1 期
Study of efficacy and safety of secukinumab 300 mg in adult patients with biopsy-proven forms of lichen planusichen planusMedDRA version: 20.0Level: PTClassification code 10024429Term: Lichen planusSystem Organ Class: 10040785 - Skin and subcutaneous tissue disordersEUCTR2019-003588-24-FRovartis Pharma AG108