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Evaluating the Use of a Silastic Spring-Loaded Silo for Infants With Gastroschisis

NCT00539292 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 88

Last updated 2024-06-24

Study results available
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Summary

This study seeks to evaluate whether the routine, primary use of the spring-loaded silo (SLS) to treat infants with gastroschisis will result in improved outcomes, faster recovery times and fewer post-surgical complications than the standard selective use of the silo.

Conditions

  • Gastroschisis

Interventions

PROCEDURE

Primary placement of a spring-loaded silo

PROCEDURE

Primary Closure

primary closure of abdomen

Sponsors & Collaborators

  • The Hospital for Sick Children

    lead OTHER

Principal Investigators

  • Jacob Langer, MD · The Hospital for Sick Children, Toronto Canada

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
1 Day
Max Age
30 Days
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2001-06-30
Primary Completion
2006-12-31
Completion
2006-12-31

Countries

  • Canada

Study Locations

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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 NCT00539292 on ClinicalTrials.gov