跳至主要内容
临床试验/NCT00323453
NCT00323453已完成不适用

Rate of Surgical Wound Infection After Open Appendectomy Using the Alexis Wound Retractor

Santa Barbara Cottage Hospital2 个研究点 分布在 1 个国家目标入组 109 人开始时间: 2006年3月最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
109
试验地点
2
主要终点
Post-operative Wound Infection, After Open Appendectomy

研究概览

简要总结

The purpose of this study is to determine whether the incidence of surgical site wound infection will be reduced in open appendectomy patients through the use of the Alexis® wound retractor.

详细描述

Aim: This is a randomized comparison of open appendectomy using metal retractors and open appendectomy using the Alexis® wound retractor in patients with simple and complicated appendicitis. The study is designed in order to minimize bias by standardizing the two procedures and blinding patients and nurses during the preoperative and postoperative period.

After obtaining informed consent, or informed assent of minors, subjects will be randomized to either of two groups: one groups will undergo a standard open appendectomy using traditional metal retractors. The second group will undergo an open appendectomy with the use of the Alexis® wound retractor.

Pre-operative antibiotic Zosyn will be given prior to skin incision. Skin prep will be betadine, duraprep or gel prep. After entering the peritoneal cavity, the Alexis® retractor will be introduced and used to maintain retraction for the duration of surgery.

In simple appendicitis, the patient will receive one dose of antibiotics six hours after surgery. The patient will not receive oral antibiotics at discharge. In complicated appendicitis, the patient will be given Zosyn until afebrile for 24 hours and a normal white blood cell count. The patient will be discharged on oral antibiotics.

Follow up will occur between the 14th and 21st post operative day. At the test of cure visit, the wound will be checked for erythema, drainage, or opening. It will be assessed whether the subject received any further medical attention or received medications since discharge.

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
Triple (Participant, Investigator, Outcomes Assessor)

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

  • Clinical diagnosis of appendicitis
  • Open appendectomy
  • Ability to attend follow-up visit

排除标准

  • 未提供

研究组 & 干预措施

Experimental Arm

Experimental

The experimental arm will undergo open appendectomy utilizing the Alexis® retractor (wound protection device utilized intraoperatively), followed by standardized wound closure.

干预措施: Open appendectomy using Alexis Wound Retractor followed by standardized wound closure (Device)

Control Arm

Placebo Comparator

Open appendectomy and standardized wound closure

干预措施: Open appendectomy with standardized wound closure (Procedure)

结局指标

主要结局

Post-operative Wound Infection, After Open Appendectomy

时间窗: 21 post operative days

Wound infections will be documents in both the traditional retraction arm and the wound protections device arm. The severity of appendicitis between the two groups will be matched.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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