Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

Topical Antibiotic Irrigation (Bacitracin) in Prophylaxis of Midfacial Fracture Surgical Wounds

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03483363
Recruitment Status : Recruiting
First Posted : March 30, 2018
Last Update Posted : December 11, 2018
Sponsor:
Information provided by (Responsible Party):
Nagi Demian, The University of Texas Health Science Center, Houston

Brief Summary:
The purpose of this study is to evaluate the use of topical antibiotic irrigation (bacitracin) and its ability to reduce surgical site infections in midfacial fracture surgery compared to sterile normal saline (NS).

Condition or disease Intervention/treatment Phase
Surgical Site Infection Drug: topical irrigation with the antibiotic bacitracin Drug: topical irrigation with sterile normal saline (NS) Drug: intravenous (IV) prophylactic antibiotic Phase 4

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 200 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Topical Antibiotic Irrigation (Bacitracin) in Prophylaxis of Midfacial Fracture Surgical Wounds
Actual Study Start Date : October 9, 2018
Estimated Primary Completion Date : March 2022
Estimated Study Completion Date : March 2022

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: topical irrigation with the antibiotic bacitracin
Fractures will be irrigated with Bacitracin topical antibiotic (50,000 units) prior to closure. All groups with receive standard parenteral intravenous (IV) prophylactic antibiotic.
Drug: topical irrigation with the antibiotic bacitracin
Fractures will be irrigated with Bacitracin topical antibiotic (50,000 units) prior to closure.

Drug: intravenous (IV) prophylactic antibiotic
All groups with receive standard parenteral (IV) prophylactic antibiotic.

Active Comparator: topical irrigation with sterile normal saline (NS)
Fractures will be irrigated with sterile normal saline prior to closure. All groups with receive standard parenteral (IV) prophylactic antibiotic.
Drug: topical irrigation with sterile normal saline (NS)
Fractures will be irrigated with sterile normal saline prior to closure. All groups with receive standard parenteral (IV) prophylactic antibiotic.

Drug: intravenous (IV) prophylactic antibiotic
All groups with receive standard parenteral (IV) prophylactic antibiotic.




Primary Outcome Measures :
  1. Number of participants with surgical site infection (SSI) [ Time Frame: 8 weeks ]
    The main investigator (Dr. Demian) will determine SSI (evidence of infection: persistent swelling, fever, recurrent swelling, erythema, and purulent discharge).



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • patients who are planned for open reduction internal fixation of midfacial fractures as part of standard of care
  • patients who are admitted to Memorial Hermann hospital at Texas Medical Center
  • able to sign their own consent

Exclusion Criteria:

  • infected surgical sites
  • allergies to bacitracin

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03483363


Contacts
Layout table for location contacts
Contact: Donna M Martinez (713) 500-5082 Donna.M.Martinez@uth.tmc.edu
Contact: Nagi Demian, MDDS (713) 500-5082 Nagi.Demian@uth.tmc.edu

Locations
Layout table for location information
United States, Texas
The University of Texas Health Science Center at Houston Recruiting
Houston, Texas, United States, 77030
Sponsors and Collaborators
The University of Texas Health Science Center, Houston
Investigators
Layout table for investigator information
Principal Investigator: Nagi Demian, MDDS The University of Texas Health Science Center, Houston

Layout table for additonal information
Responsible Party: Nagi Demian, Professor, The University of Texas Health Science Center, Houston
ClinicalTrials.gov Identifier: NCT03483363    
Other Study ID Numbers: HSC-DB-18-0038
First Posted: March 30, 2018    Key Record Dates
Last Update Posted: December 11, 2018
Last Verified: December 2018

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Additional relevant MeSH terms:
Layout table for MeSH terms
Surgical Wound Infection
Surgical Wound
Wound Infection
Infection
Postoperative Complications
Pathologic Processes
Wounds and Injuries
Anti-Bacterial Agents
Bacitracin
Antibiotics, Antitubercular
Anti-Infective Agents
Antitubercular Agents
Anti-Infective Agents, Local