Wounds and InjuriesNCT02744144
Wound Bacterial Microbiota and Their Antibiotic Resistance
An observational study of Wounds and Injuries and War-Related Injuries, run by Karolinska Institutet at 1 site in Jordan.
Trial 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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Wounds and Injuries, War-Related Injuries, Wound Infection
- How many people
- 457 participants
- Where
- 1 siteJordan
- Study dates
- Sep 2014to Jun 2016
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients originating from the Syrian armed conflict who receive treatment for blast- and gunshot-injuries.
Who may be able to join
- 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
Who cannot join
- Patients that are only re-admitted during the study period, i.e. patients that received primary treatment by MSF before study initiation
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Wounds and Injuries, War-Related Injuries, Wound Infection, Wounds, Penetrating, Wounds, Gunshot, Arm Injuries
- Medical subject headings
- Wounds and Injuries, War-Related Injuries, Wound Infection, Wounds, Penetrating, Wounds, Gunshot, Arm Injuries, Leg Injuries, Soft Tissue Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Non-infection | Patients without clinical infection or positive wound culture | |
| Infection | Patients with clinical infection and positive wound culture |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of patients that develops infections after receiving surgical treatment
Measured: 30 days
Secondary outcomes (5)
Frequency of different bacterial microbiota in wounds with clinical signs of infection
For wounds with clinical signs of infection the bacterial microbiota will be characterized.
Measured: 30 days
Frequency of microbiota with antibiotic resistance in wounds with clinical signs of infection
For wounds with clinical signs of infection the the antibiotic resistance patterns of the bacterial microbiota will be characterized.
Measured: 30 days
Length of stay
Length of hospital stay
Measured: 30 days
Surgery
Number and type of surgeries
Measured: 30 days
Death
Mortality
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Apr 2016 (estimated)
- Study startSep 2014
- Primary completionJun 2016
- Study completionJun 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (11)Papers the sponsor has linked to this study.
- Other trials for Wounds and InjuriesStudies of the same condition, open and under way.
- More trials run by Karolinska InstitutetThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Other
- Enrolment
- 457 participants (actual)
Sponsor and investigators
- Lead sponsor
- Karolinska Institutet
- Sponsor type
- University, hospital or other
- Collaborators
- Medecins Sans Frontieres, Netherlands
- Responsible party
- Principal investigator, Jonas Malmstedt, Karolinska Institutet
- Investigators
- Jonas Malmstedt, MD, PhD, Study director, Karolinska Institutet
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02744144
- Sponsor's protocol ID
- KISOS002
- Status last verified
- May 2017
- First submitted
- 13 Apr 2016
- Last updated
- 1 Jun 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Publications
Fares Y, El-Zaatari M, Fares J, Bedrosian N, Yared N. Trauma-related infections due to cluster munitions. J Infect Public Health. 2013 Dec;6(6):482-6. doi: 10.1016/j.jiph.2013.05.006. Epub 2013 Jul 31.
PubMed 23999350Covey DC, Lurate RB, Hatton CT. Field hospital treatment of blast wounds of the musculoskeletal system during the Yugoslav civil war. J Orthop Trauma. 2000 May;14(4):278-86; discussion 277. doi: 10.1097/00005131-200005000-00010.
PubMed 10898201Tong MJ. Septic complications of war wounds. JAMA. 1972 Feb 21;219(8):1044-7. No abstract available.
PubMed 4621762Murray CK. Infectious disease complications of combat-related injuries. Crit Care Med. 2008 Jul;36(7 Suppl):S358-64. doi: 10.1097/CCM.0b013e31817e2ffc.
PubMed 18594263Giannou C, Baldan M. War Surgery: Working With Limited Resources in Armed Conflict and Other Situations of Violence. ICRC; 2010.
Murray CK, Hsu JR, Solomkin JS, Keeling JJ, Andersen RC, Ficke JR, Calhoun JH. Prevention and management of infections associated with combat-related extremity injuries. J Trauma. 2008 Mar;64(3 Suppl):S239-51. doi: 10.1097/TA.0b013e318163cd14.
PubMed 18316968Teicher CL, Ronat JB, Fakhri RM, Basel M, Labar AS, Herard P, Murphy RA. Antimicrobial drug-resistant bacteria isolated from Syrian war-injured patients, August 2011-March 2013. Emerg Infect Dis. 2014 Nov;20(11):1949-51. doi: 10.3201/eid2011.140835. No abstract available.
PubMed 25340505Sutter DE, Bradshaw LU, Simkins LH, Summers AM, Atha M, Elwood RL, Robertson JL, Murray CK, Wortmann GW, Hospenthal DR. High incidence of multidrug-resistant gram-negative bacteria recovered from Afghan patients at a deployed US military hospital. Infect Control Hosp Epidemiol. 2011 Sep;32(9):854-60. doi: 10.1086/661284.
PubMed 21828965Dau AA, Tloba S, Daw MA. Characterization of wound infections among patients injured during the 2011 Libyan conflict. East Mediterr Health J. 2013 Apr;19(4):356-61.
PubMed 23882961Eardley WG, Brown KV, Bonner TJ, Green AD, Clasper JC. Infection in conflict wounded. Philos Trans R Soc Lond B Biol Sci. 2011 Jan 27;366(1562):204-18. doi: 10.1098/rstb.2010.0225.
PubMed 21149356Alga A, Wong S, Shoaib M, Lundgren K, Giske CG, von Schreeb J, Malmstedt J. Infection with high proportion of multidrug-resistant bacteria in conflict-related injuries is associated with poor outcomes and excess resource consumption: a cohort study of Syrian patients treated in Jordan. BMC Infect Dis. 2018 May 22;18(1):233. doi: 10.1186/s12879-018-3149-y.
PubMed 29788910
Study at a glance
From the registry record, last updated by the sponsor on 1 Jun 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Wound Bacterial Microbiota and Their Antibiotic Resistance: a Prospective Cohort Study of Hospitalized Patients Originating From the Syrian Armed Conflict
- ClinicalTrials.gov ID
- NCT02744144
- Acronym / sponsor ID
- KISOS002
- Conditions
- Wounds and Injuries, War-Related Injuries, Wound Infection, Wounds, Penetrating, Wounds, Gunshot, Arm Injuries
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 457 participants (actual)
- Lead sponsor
- Karolinska InstitutetUniversity, hospital or other
- Collaborators
- Medecins Sans Frontieres, Netherlands
- Study start
- Sep 2014 (actual)
- Primary completion
- Jun 2016 (actual)
- Study completion
- Jun 2016 (actual)
- First posted
- 20 Apr 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Other
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Non-infection | – | –Patients without clinical infection or positive wound culture |
| Infection | – | –Patients with clinical infection and positive wound culture |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients originating from the Syrian armed conflict who receive treatment for blast- and gunshot-injuries.
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (1 listed)
- Patients that are only re-admitted during the study period, i.e. patients that received primary treatment by MSF before study initiation
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Proportion of patients that develops infections after receiving surgical treatment
Time frame: 30 days
5 secondary outcomes
Frequency of different bacterial microbiota in wounds with clinical signs of infection
Time frame: 30 days
Frequency of microbiota with antibiotic resistance in wounds with clinical signs of infection
Time frame: 30 days
Length of stay
Time frame: 30 days
Surgery
Time frame: 30 days
Death
Time frame: 30 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Jun 2017.
- Background: PubMed 23999350Fares Y, El-Zaatari M, Fares J, Bedrosian N, Yared N. Trauma-related infections due to cluster munitions. J Infect Public Health. 2013 Dec;6(6):482-6. doi: 10.1016/j.jiph.2013.05.006. Epub 2013 Jul 31.
- Background: PubMed 10898201Covey DC, Lurate RB, Hatton CT. Field hospital treatment of blast wounds of the musculoskeletal system during the Yugoslav civil war. J Orthop Trauma. 2000 May;14(4):278-86; discussion 277. doi: 10.1097/00005131-200005000-00010.
- Background: PubMed 4621762Tong MJ. Septic complications of war wounds. JAMA. 1972 Feb 21;219(8):1044-7. No abstract available.
- Background: PubMed 18594263Murray CK. Infectious disease complications of combat-related injuries. Crit Care Med. 2008 Jul;36(7 Suppl):S358-64. doi: 10.1097/CCM.0b013e31817e2ffc.
- BackgroundGiannou C, Baldan M. War Surgery: Working With Limited Resources in Armed Conflict and Other Situations of Violence. ICRC; 2010.
- Background: PubMed 18316968Murray CK, Hsu JR, Solomkin JS, Keeling JJ, Andersen RC, Ficke JR, Calhoun JH. Prevention and management of infections associated with combat-related extremity injuries. J Trauma. 2008 Mar;64(3 Suppl):S239-51. doi: 10.1097/TA.0b013e318163cd14.
- Background: PubMed 25340505Teicher CL, Ronat JB, Fakhri RM, Basel M, Labar AS, Herard P, Murphy RA. Antimicrobial drug-resistant bacteria isolated from Syrian war-injured patients, August 2011-March 2013. Emerg Infect Dis. 2014 Nov;20(11):1949-51. doi: 10.3201/eid2011.140835. No abstract available.
- Background: PubMed 21828965Sutter DE, Bradshaw LU, Simkins LH, Summers AM, Atha M, Elwood RL, Robertson JL, Murray CK, Wortmann GW, Hospenthal DR. High incidence of multidrug-resistant gram-negative bacteria recovered from Afghan patients at a deployed US military hospital. Infect Control Hosp Epidemiol. 2011 Sep;32(9):854-60. doi: 10.1086/661284.
- Background: PubMed 23882961Dau AA, Tloba S, Daw MA. Characterization of wound infections among patients injured during the 2011 Libyan conflict. East Mediterr Health J. 2013 Apr;19(4):356-61.
- Background: PubMed 21149356Eardley WG, Brown KV, Bonner TJ, Green AD, Clasper JC. Infection in conflict wounded. Philos Trans R Soc Lond B Biol Sci. 2011 Jan 27;366(1562):204-18. doi: 10.1098/rstb.2010.0225.
- Derived from this study: PubMed 29788910Alga A, Wong S, Shoaib M, Lundgren K, Giske CG, von Schreeb J, Malmstedt J. Infection with high proportion of multidrug-resistant bacteria in conflict-related injuries is associated with poor outcomes and excess resource consumption: a cohort study of Syrian patients treated in Jordan. BMC Infect Dis. 2018 May 22;18(1):233. doi: 10.1186/s12879-018-3149-y.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jonas Malmstedt, MD, PhD study director
Karolinska Institutet
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Wounds and Injuries and War-Related Injuries, run by Karolinska Institutet at 1 site in Jordan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Jun 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Jordan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of patients that develops infections after receiving surgical treatment (time frame: 30 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02744144, which also lists 11 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Jun 2017.