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Damage Control Laparotomy

NCT02706041 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 39

Last updated 2021-11-18

Study results available
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Summary

Randomized study to compare outcomes of patients undergoing damage control laparotomies versus definitive closure for which there is surgeon equipoise to randomize.

Conditions

  • Other Injury of Other Intra-abdominal Organs, Initial Encounter

Interventions

PROCEDURE

Definitive Closure Laparotomy

Subjects randomized to the definitive closure laparotomy arm will have the incision closed at the end of the exploratory laparotomy.

PROCEDURE

Damage Control Laparotomy

Subjects randomized to the damage control laparotomy arm will have the incision left open at the end of the exploratory laparotomy. The trauma team will evaluate the patient's clinical course to determine when the incision can be closed.

Sponsors & Collaborators

  • National Center for Advancing Translational Sciences (NCATS)

    collaborator NIH

  • The University of Texas Health Science Center, Houston

    lead OTHER

Principal Investigators

  • John Harvin, MD · The University of Texas Health Science Center, Houston

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
16 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-07-01
Primary Completion
2019-11-30
Completion
2020-04-30

Countries

  • United States

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 NCT02706041 on ClinicalTrials.gov