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临床试验/NCT02102685
NCT02102685已完成3 期

Vacuum Assisted Closure in Deep Neck Abscess

Instituto Mexicano del Seguro Social2 个研究点 分布在 1 个国家目标入组 28 人开始时间: 2010年9月最近更新:
适应症

试验速览

阶段
3 期
状态
已完成
入组人数
28
试验地点
2
主要终点
Granulation tissue percentage

研究概览

简要总结

The presence of deep abscess in the neck is potentially severe, it can also lead to death in short term. The surgical treatment is indicated when there is commitment of the airway, critical condition, septicemia, complications, descendent infections, diabetes mellitus with no improving during the first 48 hours of parenteral antibiotic treatment and subsequent healing of the wounds until it heals by second intention. In this study investigators propose the use of vacuum Assisted Closure (VAC) that has been used satisfactorily to reduce edema, promote granulation, and ameliorate the tissue to afterwards reconstruct the defect, increase vascularity and diminish the bacterial load.

详细描述

Objective

To evaluate the therapeutic efficacy of the combination of vacuum-assisted in comparison with traditional therapy in wound healing in deep neck abscess.

Material and Methods Type of Study: Clinical Trial (Randomized) controlled This project was performed in patients from the Service of Otolaryngology, IMSS, diagnosed with deep neck abscess.

Procedure There were two groups: Group A, 14 patients treated with VAC therapy, group B, patients treated with conventional therapy Group A: within the first three days the VAC therapy will be placed , proceeding as follows : organize the material , bandage removal , cleaning of the wound with irrigation solution , cut the sponge and placement on the wound , use of polyvinyl alcohol and / or silver foam, insertion of the tube seal and connection to the containing recipient. Wound cleaning will performed with irrigating solution and replacement of the sponges every 72 hours according to evolution, photographs will be taken to assess the percentage of viable tissue and granulation. A Sample to culture will be taken prior to placement of VAC therapy , during the use of it and at the time of removal of the system. When the wound presents clinical signs of improvement (elimination of purulent discharge and granulation tissue ) VAC therapy will be withdrawn , and follow by delayed primary closure.

Patients will be assign to group B: 14 patients on admission, after surgical drainage, a culture will be taken, photographs every three days (during hospital stay ) and secretion culture; daily cleaning stipulated by the service will be perform. The control of the patients will be made until wound closure (presence of epithelialization tissue) .

Statistical Analysis Nominal variables will be analyzed using percentage frequencies, X2 test or Fisher exact test. Numeric variables using Student's t test for independent samples and ANOVA with post hoc Scheffe test. U Mann Whitney and Kruskal Wallis tests will be used as long as data do not conform to normal distribution. All values of p <0.05 will be considered statistically significant. The analysis will be perform with statistical program SPSS v. 18 for Windows program.

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

入选标准

  • Male or female patients of 18 years or older
  • Diagnosis of Deep Neck Abscess users of the Mexican Institute of Social Security
  • Incision from the anterior edge of the SCM muscle to unilateral or bilateral paratracheal line
  • Spread of infection to a space larger than 7 cm
  • Patients with systemic diseases

排除标准

  • Patients with extensive necrosis of tissue that does not allow the suture of the wound
  • Patients who for some reason do not conclude the study
  • Patients with complications that require taking off the VAC Therapy
  • Patients who miss their follow

结局指标

主要结局

Granulation tissue percentage

时间窗: every 3 days up to 3 months

the percentage of granulation tissue will be evaluated by a software called image Image J

次要结局

  • complications(every 3 days up to 3 months)
  • microorganisms(every 7 days up to 3 months)

研究者

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

CLOTILDE FUENTES OROZCO

PhD

Instituto Mexicano del Seguro Social

研究点 (2)

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