HydrocephalusNCT04785248
Clinical Observation of V-P Shunt and Application of "Three-step Disinfection" to Reduce Post-operative Infection Rate
A study testing Three-step disinfection in people with Hydrocephalus and Ventriculoperitoneal Shunt, run by Baiyun Liu at 1 site in China.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Hydrocephalus, Ventriculoperitoneal Shunt
- What is being tested?
- Three-step disinfection
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 600 participants
- Where
- 1 siteChina
- Study dates
- 30 Jun 2021to 1 Apr 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥ 18, regardless of gender.
- Patients with hydrocephalus of high, normal and low pressure caused by various reasons need V-P shunt and meet the operation indications.
- Before the start of the trial, a written informed consent signed by the subject himself or his legal representative must be obtained.
Who cannot join
- Patients who had participated in clinical trials of other drugs or medical devices within 6 months.
- 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.
- Patients with severe diseases of other systems, such as severe diseases of the hematological, respiratory, digestive, and urinary systems, were combined.
- Patients with co-existing infectious diseases.
- Pregnant, lactating female patient.
- Physicians judged other situations in which they could not participate in the trial.
- The subjects themselves or their legal surrogates refused to participate in the clinical trial.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Beijing TianTan Hospital affliated to Capital Medical University
Beijing, Beijing Municipality
Lu Shenghua, bachlor, +86 15301029693, lu960903@163.com
About this study
Official title: 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.
Read the 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:
- 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.
- 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;
- 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.
- Conditions
- Hydrocephalus, Ventriculoperitoneal Shunt
- Being tested
- Three-step disinfection
- Keywords
- Ventriculoperitoneal Shunt, Surgical Wound Infection, Disinfection
- Medical subject headings
- Hydrocephalus, Surgical Wound Infection
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Three-step disinfectionProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| Controlled group | No intervention | the routine preoperative disinfection method |
| Three-step disinfection | Experimental | new developed method of preoperative disinfection Receives: Procedure: Three-step disinfection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of postoperation Intracranial infection
post-operation intracranial infection(diagnosed by lumbar puncture)
Measured: 10 days post-operation to 12 month post-operation
Rate of postoperation Intra-abdominal infection
Post-operation abdominal-cavity infection(diagnosed by WBC counting and clinical feature)
Measured: 10 days post-operation to 12 month post-operation
Secondary outcomes (2)
Rate of Ventriculoperitoneal shunt malfunction
jammed or over draining of the shunt
Measured: 10 days post-operation to 12 month post-operation
Rate of postoperation Surgical wound infection
infection of surgical site, while intracranial and intraabdominal infection can be excluded.
Measured: 10 days post-operation to 12 month post-operation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Mar 2021
- Study start30 Jun 2021 (estimated)
- Primary completion1 Apr 2023 (estimated)
- Study completion1 Apr 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for HydrocephalusStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 600 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Baiyun Liu
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Baiyun Liu, Beijing Tiantan Hospital
- Investigators
- Baiyun Liu, Ph.D, Study chair, Beijing Tiantan Hospital affiliate to Capital Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04785248
- Sponsor's protocol ID
- BTHospital HX-A-035(2020)
- Other IDs
- BTHospital KY2021-016-03
- Status last verified
- Jun 2021
- First submitted
- 3 Mar 2021
- Last updated
- 30 Jun 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Wu Y, Green NL, Wrensch MR, Zhao S, Gupta N. Ventriculoperitoneal shunt complications in California: 1990 to 2000. Neurosurgery. 2007 Sep;61(3):557-62; discussion 562-3. doi: 10.1227/01.NEU.0000290903.07943.AF.
PubMed 17881969McGirt MJ, Zaas A, Fuchs HE, George TM, Kaye K, Sexton DJ. Risk factors for pediatric ventriculoperitoneal shunt infection and predictors of infectious pathogens. Clin Infect Dis. 2003 Apr 1;36(7):858-62. doi: 10.1086/368191. Epub 2003 Mar 18.
PubMed 12652386Choux M, Genitori L, Lang D, Lena G. Shunt implantation: reducing the incidence of shunt infection. J Neurosurg. 1992 Dec;77(6):875-80. doi: 10.3171/jns.1992.77.6.0875.
PubMed 1432129Rozzelle CJ, Leonardo J, Li V. Antimicrobial suture wound closure for cerebrospinal fluid shunt surgery: a prospective, double-blinded, randomized controlled trial. J Neurosurg Pediatr. 2008 Aug;2(2):111-7. doi: 10.3171/PED/2008/2/8/111.
PubMed 18671615Working Group on Neurosurgical Outcomes Monitoring; Woo PY, Wong HT, Pu JK, Wong WK, Wong LY, Lee MW, Yam KY, Lui WM, Poon WS. Primary ventriculoperitoneal shunting outcomes: a multicentre clinical audit for shunt infection and its risk factors. Hong Kong Med J. 2016 Oct;22(5):410-9. doi: 10.12809/hkmj154735. Epub 2016 Aug 26.
PubMed 27562986Erps A, Roth J, Constantini S, Lerner-Geva L, Grisaru-Soen G. Risk factors and epidemiology of pediatric ventriculoperitoneal shunt infection. Pediatr Int. 2018 Dec;60(12):1056-1061. doi: 10.1111/ped.13709. Epub 2018 Dec 10.
PubMed 30290047Yang YN, Zhang J, Gu Z, Song YL. The risk of intracranial infection in adults with hydrocephalus after ventriculoperitoneal shunt surgery: A retrospective study. Int Wound J. 2020 Jun;17(3):722-728. doi: 10.1111/iwj.13331. Epub 2020 Feb 19.
PubMed 32073232
Study at a glance
From the registry record, last updated by the sponsor on 30 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT04785248
- Acronym / sponsor ID
- BTHospital HX-A-035(2020)
- Conditions
- Hydrocephalus, Ventriculoperitoneal Shunt
- Keywords
- Ventriculoperitoneal Shunt, Surgical Wound Infection, Disinfection
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 600 participants (estimated)
- Lead sponsor
- Baiyun LiuUniversity, hospital or other
- Study start
- 30 Jun 2021 (estimated)
- Primary completion
- 1 Apr 2023 (estimated)
- Study completion
- 1 Apr 2024 (estimated)
- First posted
- 5 Mar 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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:
- 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.
- 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;
- 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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Controlled group | No intervention | –the routine preoperative disinfection method |
| Three-step disinfection | Experimental | Procedure: Three-step disinfectionnew developed method of preoperative disinfection |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Age ≥ 18, regardless of gender.
- Patients with hydrocephalus of high, normal and low pressure caused by various reasons need V-P shunt and meet the operation indications.
- Before the start of the trial, a written informed consent signed by the subject himself or his legal representative must be obtained.
Key exclusion criteria (7 listed)
- Patients who had participated in clinical trials of other drugs or medical devices within 6 months.
- 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.
- Patients with severe diseases of other systems, such as severe diseases of the hematological, respiratory, digestive, and urinary systems, were combined.
- Patients with co-existing infectious diseases.
- Pregnant, lactating female patient.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Three-step disinfectionThree 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. | Procedure or surgery | Three-step disinfection |
Primary outcome
Rate of postoperation Intracranial infection
Time frame: 10 days post-operation to 12 month post-operation
post-operation intracranial infection(diagnosed by lumbar puncture)
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)
2 secondary outcomes
Rate of Ventriculoperitoneal shunt malfunction
Time frame: 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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jun 2021.
- Background: PubMed 17881969Wu Y, Green NL, Wrensch MR, Zhao S, Gupta N. Ventriculoperitoneal shunt complications in California: 1990 to 2000. Neurosurgery. 2007 Sep;61(3):557-62; discussion 562-3. doi: 10.1227/01.NEU.0000290903.07943.AF.
- Background: PubMed 12652386McGirt MJ, Zaas A, Fuchs HE, George TM, Kaye K, Sexton DJ. Risk factors for pediatric ventriculoperitoneal shunt infection and predictors of infectious pathogens. Clin Infect Dis. 2003 Apr 1;36(7):858-62. doi: 10.1086/368191. Epub 2003 Mar 18.
- Background: PubMed 1432129Choux M, Genitori L, Lang D, Lena G. Shunt implantation: reducing the incidence of shunt infection. J Neurosurg. 1992 Dec;77(6):875-80. doi: 10.3171/jns.1992.77.6.0875.
- Background: PubMed 18671615Rozzelle CJ, Leonardo J, Li V. Antimicrobial suture wound closure for cerebrospinal fluid shunt surgery: a prospective, double-blinded, randomized controlled trial. J Neurosurg Pediatr. 2008 Aug;2(2):111-7. doi: 10.3171/PED/2008/2/8/111.
- Background: PubMed 27562986Working Group on Neurosurgical Outcomes Monitoring; Woo PY, Wong HT, Pu JK, Wong WK, Wong LY, Lee MW, Yam KY, Lui WM, Poon WS. Primary ventriculoperitoneal shunting outcomes: a multicentre clinical audit for shunt infection and its risk factors. Hong Kong Med J. 2016 Oct;22(5):410-9. doi: 10.12809/hkmj154735. Epub 2016 Aug 26.
- Background: PubMed 30290047Erps A, Roth J, Constantini S, Lerner-Geva L, Grisaru-Soen G. Risk factors and epidemiology of pediatric ventriculoperitoneal shunt infection. Pediatr Int. 2018 Dec;60(12):1056-1061. doi: 10.1111/ped.13709. Epub 2018 Dec 10.
- Background: PubMed 32073232Yang YN, Zhang J, Gu Z, Song YL. The risk of intracranial infection in adults with hydrocephalus after ventriculoperitoneal shunt surgery: A retrospective study. Int Wound J. 2020 Jun;17(3):722-728. doi: 10.1111/iwj.13331. Epub 2020 Feb 19.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Baiyun Liu, Ph.D study chair
Beijing Tiantan Hospital affiliate to Capital Medical University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Three-step disinfection in people with Hydrocephalus and Ventriculoperitoneal Shunt, run by Baiyun Liu at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 30 Jun 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact ShengHua Lu, BA (+86 15301029693, Lu960903@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rate of postoperation Intracranial infection (time frame: 10 days post-operation to 12 month post-operation). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04785248, which also lists 7 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Jun 2021.