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

June 29, 2021 updated by: Baiyun Liu

A Prospective Clinical Observation of Ventriculo-Peritoneal Shunt in Patients With Normal or Low Hydrocephalus and A Multi-Center Randomized Controlled Study on Application of "Three-step Disinfection" in Reducing the Incidence of Post-operative Infection

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

Data Collection:

Preoperative symptoms and signs, medical records, imaging data, preoperative functional scores (Glasgow score, ADL score, jnphgsr score) were collected.

Data Security Monitoring:

  1. Follow-up after surgery according to the study scheme, and comprehensive collection of safety data, for key patient researchers should focus on, in order to comprehensively and early detection of all kinds of adverse events.
  2. All adverse events are well documented, properly handled and tracked until they are properly resolved or stable, and serious and unexpected events are reported to the ethics committee, competent authorities, applicants and pharmaceutical supervisory and administrative departments in a timely manner as required;
  3. Major investigators regularly conduct cumulative reviews of all adverse events and, if necessary, hold researcher meetings to assess the risks and benefits of the study;

Data Preservation:

The experimental data is stored in Access database and stored locally after entering electronic data. This clinical trial uses the subject's Research Medical Record as the original data source. Researchers need to record the subject's data in the Case Report Form according to the Research Medical Record. The sponsors will verify the integrity, accuracy and authenticity of the data in Case Report Form.After completing the enrollment, complete Case Report Form is required and the first Case Report Form copy is withdrawn by the sponsor.At the end of the study, the original data, informed consent and remaining Case Report Form data will be kept at the various research centers as required.The retention period was 10 years after the end of the clinical trial.

Statistical analysis was performed by double-sided test, with P < 0.05 being statistically significant except for those specified in particular; measurements were described by means, medians, standard deviations, maximum and minimum values; counts or ranks were expressed by frequency and frequency.

Statistical Processing:

Homogeneity between groups was compared by t test, chi-square test or rank sum test.

Efficacy evaluation: Continuous corrected chi-2 test was used to compare the intracranial infection rates within 365 days after surgery. The unilateral 95% confidence interval of difference between the two groups was calculated. If the lower limit of the confidence interval was greater than -10%, the superiority was established, that is, the experimental group was superior to the control group.

Sample Size and Research Plan:

Statistical analysis uses Statistical Product and Service Solutions(SPSS) 26.0 software, the analysis process is all programmed.

The trial was designed for superiority and inferiority according to "Chow, S.C., Shao, J., and Wang, H. 2008. Sample Size Calculations in Clinical Research, Second Edition. Chapman & Hall/CRC. Boca Raton,Florida. "The main efficacy indicators were the intracranial infection rate in one year after operation. The estimated infection rate was 2.8% in the experimental group and 9.5% [18] in the control group. The other relevant parameters were set as follows: Class I error alpha=0.05 (unilateral), test efficiency 1-beta=0.8, and the number of cases in the experimental group and the control group was designed as 1:1.Comparing sample size calculation formulas based on two sample rates:

To calculate the sample size, 156 cases in the experimental group and 156 cases in the control group were obtained. Considering the dropout rate of no more than 15%, 180 cases in the experimental group and 180 cases in the control group were planned to be enrolled. The total number of cases in the two groups was 360.This study requires at least 360 patients to have sufficient test intensity to avoid false negative. In the design of the study, 600 patients were initially recruited, of whom 200 were from our center and 400 were from other centers.

Study Type

Interventional

Enrollment (Anticipated)

600

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
    • Beijing
      • Beijing, Beijing, China
        • Recruiting
        • Beijing TianTan Hospital affliated to Capital Medical University
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. Age ≥ 18, regardless of gender.
  2. Patients with hydrocephalus of high, normal and low pressure caused by various reasons need V-P shunt and meet the operation indications.
  3. Before the start of the trial, a written informed consent signed by the subject himself or his legal representative must be obtained.

Exclusion Criteria:

  1. Patients who had participated in clinical trials of other drugs or medical devices within 6 months.
  2. Patients with abnormal coagulation mechanisms or who had received treatment with thrombolytic agents, anticoagulants, or inhibitors of platelet coagulation within 2 weeks, and patients with hemophilia.
  3. Patients with severe diseases of other systems, such as severe diseases of the hematological, respiratory, digestive, and urinary systems, were combined.
  4. Patients with co-existing infectious diseases.
  5. Pregnant, lactating female patient.
  6. Physicians judged other situations in which they could not participate in the trial.
  7. The subjects themselves or their legal surrogates refused to participate in the clinical trial.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: Controlled group
the routine preoperative disinfection method
Experimental: Three-step disinfection
new developed method of preoperative disinfection
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Rate of postoperation Intracranial infection
Time Frame: 10 days post-operation to 12 month post-operation
post-operation intracranial infection(diagnosed by lumbar puncture)
10 days post-operation to 12 month post-operation
Rate of postoperation Intra-abdominal infection
Time Frame: 10 days post-operation to 12 month post-operation
Post-operation abdominal-cavity infection(diagnosed by WBC counting and clinical feature)
10 days post-operation to 12 month post-operation

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Rate of Ventriculoperitoneal shunt malfunction
Time Frame: 10 days post-operation to 12 month post-operation
jammed or over draining of the shunt
10 days post-operation to 12 month post-operation
Rate of postoperation Surgical wound infection
Time Frame: 10 days post-operation to 12 month post-operation
infection of surgical site, while intracranial and intraabdominal infection can be excluded.
10 days post-operation to 12 month post-operation

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Barthel Index of activities of daily living
Time Frame: prior operation and 6\12 month time point
assess patients capability of activities of daily living
prior operation and 6\12 month time point
Glasgow coma scale(GCS)
Time Frame: prior operation and 10 days post-operation to 12 month post-operation
assess post-traumatic hydrocephalus patient's conscious status
prior operation and 10 days post-operation to 12 month post-operation

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Baiyun Liu

Investigators

  • Study Chair: Baiyun Liu, Ph.D, Beijing Tiantan Hospital affiliate to Capital Medical University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

June 30, 2021

Primary Completion (Anticipated)

April 1, 2023

Study Completion (Anticipated)

April 1, 2024

Study Registration Dates

First Submitted

March 3, 2021

First Submitted That Met QC Criteria

March 3, 2021

First Posted (Actual)

March 5, 2021

Study Record Updates

Last Update Posted (Actual)

June 30, 2021

Last Update Submitted That Met QC Criteria

June 29, 2021

Last Verified

June 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • BTHospital HX-A-035(2020)
  • BTHospital KY2021-016-03 (Other Identifier: IRB of Beijing Tiantan Hospital)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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