跳至主要内容
临床试验/NCT01188954
NCT01188954撤回不适用

Randomized Clinical Trial of Doxycycline Versus Standard Care to Prevent Seroma Formation at Femoral Artery/Vein Cannulation Site After Cardiopulmonary By-Pass

Northwell Health1 个研究点 分布在 1 个国家开始时间: 2010年1月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
状态
撤回
试验地点
1
主要终点
evaluate the efficacy of doxycycline in the prevention of the complication of seroma post-cannulation

研究概览

简要总结

A seroma is a collection of fluid other than pus or blood which forms through the division of numerous lymphatic channels, which normally drain the interstitial space under the skin. These channels become disrupted during surgical procedure and lead to seroma formation. This collection of fluid causes pressure in the local area, patient discomfort, and provides unfortunately an excellent culture medium for bacteria. Seroma development has been previously described in femoral vessel groin cannulation dissections after surgery. Conventional therapy is limited to draining the fluid, sometimes more than once, until there is full resolution of the seroma. If fluid collection recurs at the surgical site, sclerosant therapy with agents such as doxycycline. Doxycycline has been found to be a cost effective agent used as a sclerosant, which belongs to tetracycline class of antibiotics. The investigators hypothesize that prophylactic use of doxycycline at the site of femoral cannulation will prevent or minimize the area of seroma formation as compared to standard care of patients. The aim is driven towards limiting patient discomfort and visits to the clinic and to improve clinical care.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
Single (Participant)

入排标准

年龄范围
18 Years 至 85 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Male and female candidates (>18 and <85 years of age) undergoing Cardiopulmonary By-Pass via Femoral/Groin access as part of their routine cardiothoracic scheduled procedure will be approached for their interest in participation in the study.

排除标准

  • A history of allergic reaction to doxycycline (Adoxa, Doryx, Oracea, Vibramycin) or any classes of tetracyclines- demeclocycline (Declomycin), or minocycline (Dynacin, Minocin, Solodyn, Vectrin).
  • Patients who are not undergoing Cardiopulmonary By-Pass through femoral access.
  • Active infection in the groin region.
  • Females who are pregnant or lactating and breast feeding.
  • Who do not wish to participate in the study.

研究组 & 干预措施

Doxycycline

Active Comparator

Doxycyline, family of tetracycline antibiotics, used to scleroses the lymphatic vessels that may have transected during dissection.

干预措施: doxycycline (Drug)

Normal Saline/Water

Placebo Comparator

The standard care is wetting and suctioning fluids followed with suturing of the groin.

干预措施: No intervention (Other)

结局指标

主要结局

evaluate the efficacy of doxycycline in the prevention of the complication of seroma post-cannulation

时间窗: 1 year

The primary aim of this study is to evaluate the efficacy of doxycycline in the prevention of the complication of seroma post-cannulation for cardiopulmonary bypass via femoral access, when compared to standard care.

次要结局

  • Identification of predictors of response and complication(1 year)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

John P Nabagiez, MD

M.D.

Northwell Health

研究点 (1)

Loading locations...

相似试验

已完成
不适用
Trial of Doxycycline to Reduce Sputum MMP-9 Activity in Adult Cystic Fibrosis (CF) PatientsCystic Fibrosis
NCT01112059University of Alabama at Birmingham40
进行中(未招募)
不适用
PEGYLATED LIPOSOMAL DOXORUBICIN (CAELYX), CISPLATINUMAND FLUOROURACIL AS CONTINUOUS INFUSION (CCF) PLUSTRASTUZUMAB (HERCEPTIN) IN THE PREOPERATIVE TREATMENT OFLOCALLY ADVANCED BREAST CANCER - NDlocally advanced breast cancerMedDRA version: 6.1Level: PTClassification code 10057654
EUCTR2006-006010-15-ITISTITUTO EUROPEO DI ONCOLOGIA
进行中(未招募)
不适用
PEGYLATED LIPOSOMAL DOXORUBICIN (CAELYX), CISPLATINUM AND FLUOROURACIL AS CONTINUOUS INFUSION (CCF) IN LOCALLYADVANCED BREAST CANCER - NDlocally advanced breast cancerMedDRA version: 9.1Level: LLTClassification code 10057654Term: Breast cancer female
EUCTR2006-004856-19-ITISTITUTO EUROPEO DI ONCOLOGIA
进行中(未招募)
1 期
RECHALLENGE WITH PEGYLATED LIPOSOMAL DOXORUBICIN ADDED TO TRABECTEDIN IN RECURRENT OVARIAN CANCER: A MULTICENTER, PROSPECTIVE TRIAL (REPRAB study – MITO 36)MedDRA version: 22.0Level: LLTClassification code 10026311Term: Malignant neoplasm of ovary and other uterine adnexaSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)MedDRA version: 20.0Level: PTClassification code 10061535Term: Ovarian neoplasmSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)MedDRA version: 20.0Level: PTClassification code 10061344Term: Peritoneal neoplasmSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)Ovarian cancer
EUCTR2017-004690-14-ITFONDAZIONE POLICLINICO UNIVERSITARIO AGOSTINO GEMELLI IRCCS UNIVERSITA' CATTOLICA DEL SACRO CUORE64
已完成
1 期
A Trial of Doxycycline in Renal DiseaseChronic Kidney DiseaseCardiorenal Syndrome
NCT02753426University of California, San Francisco11