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

NCT04785248 | Unknown DMC

• 2 other identifiers: BTHospital HX-A-035(2020)BTHospital KY2021-016-03
• Study Type: interventional
• Target: 600
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Ventriculoperitoneal Shunt; Surgical Wound Infection; Disinfection

Outcome Measures

Primary Outcomes (2)

• Rate of postoperation Intracranial infection

  post-operation intracranial infection(diagnosed by lumbar puncture)

  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)

  10 days post-operation to 12 month post-operation

Secondary Outcomes (2)

• Rate of Ventriculoperitoneal shunt malfunction

  10 days post-operation to 12 month post-operation

• Rate of postoperation Surgical wound infection

  10 days post-operation to 12 month post-operation

Other Outcomes (2)

• Barthel Index of activities of daily living

  prior operation and 6\12 month time point

• Glasgow coma scale(GCS)

  prior operation and 10 days post-operation to 12 month post-operation

Study Arms (2)

Controlled group

NO INTERVENTION

the routine preoperative disinfection method

Three-step disinfection

EXPERIMENTAL

new developed method of preoperative disinfection

Procedure: Three-step disinfection

Interventions

Three-step disinfection PROCEDURE

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.

Three-step disinfection

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Baiyun Liu: lead

Study Sites (1)

Beijing TianTan Hospital affliated to Capital Medical University

Beijing, Beijing Municipality, China

RECRUITING

Related Publications (7)

• 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.

  PMID: 17881969 BACKGROUND

• McGirt 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.

  PMID: 12652386 BACKGROUND

• Choux 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.

  PMID: 1432129 BACKGROUND

• Rozzelle 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.

  PMID: 18671615 BACKGROUND

• Working 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.

  PMID: 27562986 BACKGROUND

• Erps 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.

  PMID: 30290047 BACKGROUND

• Yang 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.

  PMID: 32073232 BACKGROUND

MeSH Terms

Conditions

Hydrocephalus; Surgical Wound Infection

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Wound Infection; Infections; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Baiyun Liu, Ph.D

  Beijing Tiantan Hospital affiliate to Capital Medical University

  STUDY CHAIR

Central Study Contacts

ShengHua Lu, BA

CONTACT

+86 15301029693; Lu960903@163.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor, Chief Physician

Study Record Dates

• First Submitted: March 3, 2021
• First Posted: March 5, 2021
• Study Start: June 30, 2021
• Primary Completion: April 1, 2023
• Study Completion: April 1, 2024
• Last Updated: June 30, 2021

Record last verified: 2021-06

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)