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A Study of an Antibiotic Implant in General Surgical Subjects at Higher Risk for Surgical Wound Infection

NCT00600925 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 602

Last updated 2021-09-24

Study results available
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Summary

The purpose of this study is to determine whether the gentamicin-collagen sponge is safe and effective for preventing surgical wound infections in patients undergoing colorectal surgery.

Conditions

  • Colorectal Surgery
  • Surgical Wound Infection

Interventions

DRUG

gentamicin-collagen sponge dipped in saline

2 gentamicin-collagen sponges inserted before closure of the laparotomy

Sponsors & Collaborators

  • Duke University

    collaborator OTHER

  • Premier Research Group plc

    collaborator UNKNOWN

  • Innocoll

    lead INDUSTRY

Principal Investigators

  • David Prior · Innocoll

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2008-01-31
Primary Completion
2009-03-31
Completion
2010-09-30

Countries

  • United States

Study Locations

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Entities

Companies

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 NCT00600925 on ClinicalTrials.gov