Wound Bacterial Microbiota and Their Antibiotic Resistance

May 31, 2017 updated by: Jonas Malmstedt, Karolinska Institutet

Wound Bacterial Microbiota and Their Antibiotic Resistance: a Prospective Cohort Study of Hospitalized Patients Originating From the Syrian Armed Conflict

The purpose of the study is to explore the microbiology in war-associated wounds of hospitalized patients from the Syrian armed conflict. Cultures collected from acute wounds with clinical signs of infection will be analyzed.

Study Overview

Status

Completed

Conditions

Detailed Description

War-associated injuries often result in soft tissue and bone being contaminated with foreign material, leading to infection (Fares et al. 2013; Covey, Lurate, and Hatton 2000). Wound infections remain the greatest risk to life and restoration of function in war-wounded that survive the first few hours (Tong 1972; Murray 2008).

The Syrian armed conflict broke out in 2011 and quickly deteriorated. Médecins Sans Frontières/Doctors Without Borders (MSF) runs an emergency trauma project in the Ministry of Health hospital in Ar Ramtha, Jordan, less than five kilometers from the Syrian border. At this facility patients from the Syrian armed conflict receive treatment for blast- and gunshot-injuries. Wounds are treated according to the International Committee of the Red Cross war surgery protocol (Giannou and Baldan 2010). Wound management and healing has been difficult and time consuming, often complicated by infections and antibiotic resistance.

Recommendations for treatment of war-associated infections are generally not supported by cohort studies (Murray et al. 2008). High rates of war wound infections caused by antimicrobial drug resistant organisms have been shown in the Middle East but reports generally only include combatants. Due to the use of body armor and forward medical therapy this data may not be applicable to a civilian setting. Furthermore, available studies are either performed on old wounds (Teicher et al. 2014) or on all available culture samples, disregarding infection signs (Sutter et al. 2011; Dau, Tloba, and Daw 2013). Without clinical signs of infection, routine collection of peri-debridement culture samples is inappropriate in war-associated injuries (Murray et al. 2008). The differentiation between contamination and infecting organisms is crucial in order to avoid unnecessary medication, especially limit the use of broad-spectrum antibiotics as overuse may lead to development of multi-drug resistant organisms (Eardley et al. 2011). Cultures collected from acute wounds with clinical signs of infection will be analyzed.

Study Type

Observational

Enrollment (Actual)

457

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Jordan
    • Irbid
      • Ar Ramtha, Irbid, Jordan
        • Ministry of Health Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients originating from the Syrian armed conflict who receive treatment for blast- and gunshot-injuries.

Description

Inclusion Criteria:

  • Patients that receive surgical treatment for war-associated injuries, irrespective of injury location, injury mechanism, time from injury and prior treatment
  • Patients that receive treatment during the study period and are later re-admitted will only be counted as one patient

Exclusion Criteria:

  • Patients that are only re-admitted during the study period, i.e. patients that received primary treatment by MSF before study initiation

Study Plan

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

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Other

Cohorts and Interventions

Group / Cohort
Non-infection
Patients without clinical infection or positive wound culture
Infection
Patients with clinical infection and positive wound culture

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Proportion of patients that develops infections after receiving surgical treatment
Time Frame: 30 days
30 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Frequency of different bacterial microbiota in wounds with clinical signs of infection
Time Frame: 30 days
For wounds with clinical signs of infection the bacterial microbiota will be characterized.
30 days
Frequency of microbiota with antibiotic resistance in wounds with clinical signs of infection
Time Frame: 30 days
For wounds with clinical signs of infection the the antibiotic resistance patterns of the bacterial microbiota will be characterized.
30 days
Length of stay
Time Frame: 30 days
Length of hospital stay
30 days
Surgery
Time Frame: 30 days
Number and type of surgeries
30 days
Death
Time Frame: 30 days
Mortality
30 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Karolinska Institutet

Collaborators

Medecins Sans Frontieres, Netherlands

Investigators

  • Study Director: Jonas Malmstedt, MD, PhD, Karolinska Institutet

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 1, 2014

Primary Completion (Actual)

June 1, 2016

Study Completion (Actual)

June 1, 2016

Study Registration Dates

First Submitted

April 13, 2016

First Submitted That Met QC Criteria

April 19, 2016

First Posted (Estimate)

April 20, 2016

Study Record Updates

Last Update Posted (Actual)

June 1, 2017

Last Update Submitted That Met QC Criteria

May 31, 2017

Last Verified

May 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • KISOS002

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

Study Data/Documents

  1. Statistical Analysis Plan

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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