Wound Bacterial Microbiota and Their Antibiotic Resistance

Completed

• Conditions: War-Related Injuries; Wound Infection; Wounds, Gunshot; Leg Injuries; Soft Tissue Injuries; Wounds and Injuries; Wounds, Penetrating; Arm Injuries

• Registration Number: NCT02744144
• Lead Sponsor: Karolinska Institutet

Brief Summary

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.

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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2014-09
• Study First Submitted: 2016-04-13
• Study First Submitted QC: 2016-04-19
• Study First Posted: 2016-04-20
• Primary Completion: 2016-06
• Study Completion: 2016-06
• Status Verified: 2017-05
• Last Update Submitted: 2017-05-31
• Last Update Posted: 2017-06-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 457

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

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Exclusion Criteria

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

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Proportion of patients that develops infections after receiving surgical treatment	30 days

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Ministry of Health hospital; 🇯🇴 Ar Ramtha, Irbid, Jordan