Outcome for Patients With War-Associated Extremity Wound Infection

NCT ID: NCT03463720

Last Updated: 2018-03-13

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 843 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2010-09-27
• Study Completion Date: 2012-05-09

Brief Summary

Extremity wounds and fractures constitute the majority of war-associated traumatic injuries, both for civilians and combatants. War-associated injuries are often contaminated with foreign material, leading to infection. Wound infections is considered a major risk to life and restoration of function in war-wounded patients surviving past the first hours. In a cohort study the investigators aim to assess whether the infection itself affects patient outcome (i.e. amputation, death) when comparing patients with and patients without infection.

Detailed Description

Armed violence has occurred intermittently in northwestern Pakistan and neighboring Afghanistan since the beginning of the 1980s. In 1981 the International Committee of the Red Cross (ICRC) opened a hospital in Peshawar, Pakistan, to care for the injured from the armed conflict in Afghanistan. In 2004 the number of patients increased as a result of the emerging divergence between the State of Pakistan and militant groups in the Northwestern Pakistan. Yearly about 1000 patients with war-associated injuries, predominantly caused by gunshots and explosive devices have been treated for free at the ICRC hospital in Peshawar. The hospital is now closed.

War-associated injuries are generally treated according to the ICRC war surgical protocol. Research on the epidemiology of and risk factors for wound infection in patients with war-associated injuries is limited and primarily include military combatants, leading to a selection of young males. Due to the use of body armor and forward surgical teams this data may not be applicable to a civilian setting. It is unknown to what extent wound infection itself is a factor contributing to serious complications such as amputation and death. Knowledge is needed to gear resources towards those most in need. This research makes use of a unique database that contains both civilians and combatants of both sexes and all ages. The investigators aim to assess whether the infection itself affects patient outcome (i.e. amputation, death) when comparing patients with and patients without infection.

Conditions

Wounds and Injuries

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: RETROSPECTIVE

Study Groups

Extremity wound

Patients with extremity wounds. Infected and not infected patients will be compared.

Infected

Intervention Type: OTHER

Extremity wound, infected

Not infected

Intervention Type: OTHER

Extremity wounds, non-infected

Interventions

Infected

Extremity wound, infected

Intervention Type: OTHER

Not infected

Extremity wounds, non-infected

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• Patients that have received treatment for war-associated extremity wounds
• Patients that present at the hospital within 72 hours of injury
• Patients with valid data on baseline wound status.

Exclusion Criteria

• Patients that are re-admitted during the study period, i.e. patients that received treatment during the study period and are later re-admitted will only be counted as one patient.

• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

The International Federation of Red Cross and Red Crescent Societies

OTHER

Sponsor Role: collaborator

Karolinska Institutet

OTHER

Sponsor Role: lead

Responsible Party

Jonas Malmstedt

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Jonas Malmstedt, PhD

Role: PRINCIPAL_INVESTIGATOR

Karolinska Institutet

Locations

International Committee of the Red Cross hospital

Peshawar, Khyber Pakhtunkhwa, Pakistan

Countries

Pakistan

Other Identifiers

KISOS003

Identifier Type: -

Identifier Source: org_study_id