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A Phase I/II Double-Blind, Randomized, Controlled Study to Evaluate the Safety and Efficacy of RUT058-60

NCT02280395 · Status: TERMINATED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 9

Last updated 2021-01-12

No results posted yet for this study

Summary

This is a double-blind, randomized, parallel-group, controlled, multi-center study to evaluate the safety and efficacy of RUT058-60 (Group A) as an intra-cavity lavage compared to sterile saline (Group B) in adult subjects undergoing abdominal surgery.

Conditions

  • Postoperative Wound Infection-deep
  • Post Operative Wound Infection

Interventions

DRUG

RUT058-60

Prior to closure of the abdomen at the end of the surgical repair, each subject will undergo lavage with approximately 900 mL of RUT058-60 administered as two 400 mL intra-abdominal (peritoneal) lavages and one 100 mL lavage above the fascia.

DRUG

Sterile saline for irrigation

Prior to closure of the abdomen, each subject will undergo lavage with approximately 900 mL of sterile saline administered as two 400 mL intra-abdominal (peritoneal) lavages and one 100 mL lavage above the fascia.

Sponsors & Collaborators

  • Pulmatrix Inc.

    lead INDUSTRY

Principal Investigators

  • Traci Hedrick, MD · University of Virginia

  • Timothy I Melson, MD · Shoals Medical Trials, Helen Kellar Hospital

  • Harold Minkowitz, MD · BJJS Corporation, Memorial Hermann Memorial Medical Center

  • Paul Rider, MD · University of South Alabama Medical Center

  • Sonia Ramamoorthy, MD · University of California, San Diego

  • AnaMaria Garza, MD · PVMDI, Glendale Memorial (Dignity Health)

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-10-31
Primary Completion
2015-06-30
Completion
2015-06-30

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 NCT02280395 on ClinicalTrials.gov