Completed

A Prospective, Multicenter, Double-Blind, Randomized, Comparative Study to Evaluate the Safety, Tolerability, and Efficacy of a Single Dose of Ertapenem Sodium (MK0826) Versus Cefotetan for the Prophylaxis of Surgical Site Infection Following Elective Colorectal Surgery

What is being tested

Data Collection

Who is being recruted

Infections+2

+ Pathologic Processes

+ Postoperative Complications

Over 18 Years

See all eligibility criteria

How is the trial designed

Prevention Study

Phase 3

Interventional

Study Start: April 2002

See protocol details

Summary

Principal SponsorMerck Sharp & Dohme LLC

Last updated: December 11, 2025

Sourced from a government-validated database.Claim as a partner

Study start date: April 1, 2002

Actual date on which the first participant was enrolled.

The duration of treatment is 1 day.

Official TitleA Prospective, Multicenter, Double-Blind, Randomized, Comparative Study to Evaluate the Safety, Tolerability, and Efficacy of a Single Dose of Ertapenem Sodium (MK0826) Versus Cefotetan for the Prophylaxis of Surgical Site Infection Following Elective Colorectal Surgery

NCT00090272

Principal SponsorMerck Sharp & Dohme LLC

Last updated: December 11, 2025

Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.

Design Details

952 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Prevention Study

Prevention studies aim to stop a disease from developing. They often involve people at risk and test things like vaccines, lifestyle changes, or preventive medications.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.

Conditions

Criteria

Any sex

Biological sex of participants that are eligible to enroll.

Over 18 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

InfectionsPathologic ProcessesPostoperative ComplicationsSurgical Wound InfectionWound Infection

Criteria

Inclusion Criteria: Male or female patients 18 years of age scheduled to undergo elective colon or colorectal surgery by laparotomy must meet the following criteria: * Surgery must be scheduled in advance. * There must be adequate time to complete preoperative bowel preparation

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has no location dataSave this study to your profile to know when the location data is available.

CompletedNo study centers