Wound Bacterial Microbiota and Their Antibiotic Resistance

NCT02744144 | Completed

• 1 other identifier: KISOS002
• Study Type: observational
• Target: 457
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Outcome Measures

Primary Outcomes (1)

• Proportion of patients that develops infections after receiving surgical treatment

  30 days

Secondary Outcomes (5)

• Frequency of different bacterial microbiota in wounds with clinical signs of infection

  30 days

• Frequency of microbiota with antibiotic resistance in wounds with clinical signs of infection

  30 days

• Length of stay

  30 days

• Surgery

  30 days

• Death

  30 days

Study Arms (2)

Non-infection

Patients without clinical infection or positive wound culture

Infection

Patients with clinical infection and positive wound culture

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Karolinska Institutet: lead
• Medecins Sans Frontieres, Netherlands: collaborator

Study Sites (1)

Ministry of Health hospital

Ar Ramtha, Irbid Governorate, Jordan

Location

Related Publications (11)

• 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.

  PMID: 23999350 BACKGROUND

• Covey 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.

  PMID: 10898201 BACKGROUND

• Tong MJ. Septic complications of war wounds. JAMA. 1972 Feb 21;219(8):1044-7. No abstract available.

  PMID: 4621762 BACKGROUND

• Murray CK. Infectious disease complications of combat-related injuries. Crit Care Med. 2008 Jul;36(7 Suppl):S358-64. doi: 10.1097/CCM.0b013e31817e2ffc.

  PMID: 18594263 BACKGROUND

• Giannou C, Baldan M. War Surgery: Working With Limited Resources in Armed Conflict and Other Situations of Violence. ICRC; 2010.

  BACKGROUND

• 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.

  PMID: 18316968 BACKGROUND

• Teicher 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.

  PMID: 25340505 BACKGROUND

• Sutter 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.

  PMID: 21828965 BACKGROUND

• Dau 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.

  PMID: 23882961 BACKGROUND

• Eardley 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.

  PMID: 21149356 BACKGROUND

• Alga 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.

  PMID: 29788910 DERIVED

MeSH Terms

Conditions

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

Condition Hierarchy (Ancestors)

Infections

Study Officials

• Jonas Malmstedt, MD, PhD

  Karolinska Institutet

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: OTHER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: co-pi

Study Record Dates

• First Submitted: April 13, 2016
• First Posted: April 20, 2016
• Study Start: September 1, 2014
• Primary Completion: June 1, 2016
• Study Completion: June 1, 2016
• Last Updated: June 1, 2017

Record last verified: 2017-05

Locations

JO (1)