跳至主要内容
临床试验/NCT03842956
NCT03842956已完成不适用

"Wound Closure (Allgower) Versus Secondary Open Wound Healing of the Pin Sites After Removal of the External Fixator: Study Protocol for a Prospective, Randomized Controlled Mono-center Trial"

Luzerner Kantonsspital1 个研究点 分布在 1 个国家目标入组 241 人开始时间: 2019年1月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
241
试验地点
1
主要终点
Post surgical pin side wound infections according to center of disease control (CDC)

研究概览

简要总结

In this prospective randomized controlled single-center trial, based on a non-inferiority design, the outcome of the treatment of patients are analyzed, whereas in half of the cases the wounds are left open and the other ones are primary wound closed after local debridement after Fixator-Extern is removed. Although this topic embodies a daily business, there is no standard to be found in literature regarding the treatment of pin sites with closure by either primary or secondary intent.

详细描述

In the orthopedic department of the Kantonsspital Lucerne (LUKS) after removal of the external fixator, the pin sites at the tibia and the back of the foot are routinely treated with primary wound closure. An international survey carried out by the LUKS shows that in comparison to our standard treatment the majority of surgeons left the pin sites open during the healing process. In order to find a standardized method to treat pin sites we conduct a randomized controlled trial, in which half of the pin site wounds are left open and the other half are treated by primary wound closure after local debridement (Treatment of the first pin-side will be randomized, then alternated treatment of the consecutive pin-sides). All patients of the study participants are treated within a fixed pre- and postoperative protocol, which includes antibiotic prophylaxis with a single shot of Cefazolin 2g intravenously 30 minutes prior to surgery. The postoperative pin care includes daily inspection of the pin sites, cleaning the secondary healing wound with Ringerfundin © and disinfection with Betadine ©. Primary wound closures are dressed with dry gaze bandage. The following out-patient treatment is provided either by a Spitex support, the family doctor or by the patient himself, depending on the patients compliance. Regular follow-up consultations at 2, 6, 12, 24 and 52 weeks after surgery ensure an adequate surveillance of the healing process, whereas the examining doctor at the second and last consultation was kept in dark what therapy was chosen for pin sites of the patient. To objectify the clinical progress the pin sites are photo documented at the consultations at week 2 and 52.

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
Single (Investigator)

盲法说明

Blinded in the 6- and 52-weeks examination. So the doctor doesn't know which pin-side is treated by primary woundclosure (Allgower) or by secondary wound healing

入排标准

性别
All
接受健康志愿者

入选标准

  • Completed 18th year of age
  • Supply by external fixator
  • Signed informed consent for study participation

排除标准

  • Patients with immunodeficiency (HIV / hepatitis infection, leukemia, steroid therapy, autoimmune therapy)
  • Patients who can not perform a follow-up treatment for structural reasons (tourists, not home canton) or other reasons
  • Lack of knowledge of German
  • Lack of consent to study participation
  • invalid patients

结局指标

主要结局

Post surgical pin side wound infections according to center of disease control (CDC)

时间窗: up to 12 weeks after surgery

次要结局

  • subjective perception of the wounds(up to 52 weeks after surgery)
  • Surgical wound revision of the pin sides, carried out antibiotic therapy in a wound infection(up to 52 weeks after surgery)
  • Time to wound healing of the pin sides(up to 6 weeks after surgery)
  • Vancouver scar scale(up to 52 weeks after surgery)

研究者

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

Reto Babst

Head of Traumatology

Luzerner Kantonsspital

研究点 (1)

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