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OpenTrials
Completed

NCT Number: NCT03463720

Outcome for Patients With War-Associated Extremity Wound Infection

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.

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Key information

Conditions

Sex eligibility

All sexes

Study type

Observational

Primary location

International Committee of the Red Cross hospital

Peshawar, Khyber Pakhtunkhwa, Pakistan

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Infected

Other

Extremity wound, infected

Not infected

Other

Extremity wounds, non-infected

Primary outcomes

  1. Amputation

    Time frame: From hospital admission to discharge, an average of 15 days

    In-hospital extremity amputation. Upper or lower extremity, all levels.

Secondary outcomes

  1. Death

    Time frame: From hospital admission to discharge, an average of 15 days

    In-hospital death

Sponsors and collaborators

Lead sponsor

Karolinska Institutet

Other

Collaborators

  • The International Federation of Red Cross and Red Crescent Societies

Registry information

Important dates

Study start
2010
Primary completion
2012
Study completion
2012
First posted
Mar 13, 2018
Registry last updated
Mar 13, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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