MedTrace Logo

Clinical Observation of V-P Shunt and Application of "Three-step Disinfection" to Reduce Post-operative Infection Rate

NCT04785248 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 600

Last updated 2021-06-30

No results posted yet for this study

Summary

A randomized, single blind, parallel controlled, multicenter clinical study was performed in which patients who had undergone a cerebrospinal fluid to peritoneal shunt that met the criteria were divided into two groups (test and control) in a 1:1 ratio, with the test group applied disinfection by the "three-step sterilization method" and completed the procedure, and the control group underwent the same surgical procedure according to the routine aseptic disinfection procedure, relevant literatures were reviewed and the previous ones in our hospital were summarized, it is intended to conduct a one-year clinical observation of the two groups, to compare the perioperative and long-term infection incidence of the two groups and evaluate them comprehensively, to evaluate whether the "three-step sterilization method" disinfected patients have reduced perioperative and long term infection risk after surgery compared with previous surgery with routine disinfection procedure, and to evaluate their effectiveness.

Conditions

  • Hydrocephalus
  • Ventriculoperitoneal Shunt

Interventions

PROCEDURE

Three-step disinfection

Three step disinfection method can be divide in three part. The first step of disinfection: scalp dandruff removal + disinfection The second step of disinfection: whole head Use 2% iodine tincture to smear the whole head skin, the assistant helps to lift the head to expose the surgical field, from both eyebrows to the occipital hairline, from both sides to the neck, after the iodine tincture dry out, use 75% alcohol to deionize. Then placing more than 4 layers of operation towel under the head. The third step of disinfection: neck chest abdomen disinfection.

Sponsors & Collaborators

  • Baiyun Liu

    lead OTHER

Principal Investigators

  • Baiyun Liu, Ph.D · Beijing Tiantan Hospital affiliate to Capital Medical University

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-06-30
Primary Completion
2023-04-01
Completion
2024-04-01

Countries

  • China

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04785248 on ClinicalTrials.gov