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Optimal Method of Fascial Closure in High Risk Patients Undergoing Laparotomy

NCT02145052 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 388

Last updated 2016-03-29

No results posted yet for this study

Summary

The primary objective of this study is to identify the optimal method of fascial closure of a laparotomy incision in high risk patients for intra-abdominal complications. The investigators hypothesize that interrupted closure is associated with decreased complication rates when compared with running/continuous closure. Secondary objectives are to determine the rate of dehiscence in continuous and interrupted suture technique, and to determine the rate of wound infection, hernia formation, and mortality associated with suture technique.

Conditions

  • Fascial Closure

Interventions

OTHER

Continuous suture

A continuous suture is considered standard of care.

OTHER

Interrupted suture

Interrupted sutures are considered standard of care.

Sponsors & Collaborators

  • Massachusetts General Hospital

    lead OTHER

Principal Investigators

  • Marc A de Moya, MD · Massachusetts General Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2008-07-31
Primary Completion
2016-07-31
Completion
2016-07-31

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 NCT02145052 on ClinicalTrials.gov