Viewing Study NCT03463720


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Study NCT ID: NCT03463720
Status: COMPLETED
Last Update Posted: 2018-03-13
First Post: 2018-02-22
Is NOT Gene Therapy: False
Has Adverse Events: False

Brief Title: Outcome for Patients With War-Associated Extremity Wound Infection
Sponsor: Karolinska Institutet
Organization:

Study Overview

Official Title: Outcome for Patients With War-Associated Extremity Wound Infection
Status: COMPLETED
Status Verified Date: 2018-02
Last Known Status: None
Delayed Posting: No
If Stopped, Why?: Not Stopped
Has Expanded Access: False
If Expanded Access, NCT#: N/A
Has Expanded Access, NCT# Status: N/A
Acronym: None
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.

Study Oversight

Has Oversight DMC: False
Is a FDA Regulated Drug?: False
Is a FDA Regulated Device?: False
Is an Unapproved Device?: None
Is a PPSD?: None
Is a US Export?: None
Is an FDA AA801 Violation?: