Outcome for Patients With War-Associated Extremity Wound Infection

Wounds and Injuries Clinical Trial

Official title:

Outcome for Patients With War-Associated Extremity Wound Infection

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03463720
• Other study ID #: KISOS003
• Status: Completed
• Phase: N/A
• First received: February 22, 2018
• Last updated: March 12, 2018
• Start date: September 27, 2010
• Est. completion date: May 9, 2012

Study information

• Verified date: February 2018
• Source: Karolinska Institutet
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 843
• Est. completion date: May 9, 2012
• Est. primary completion date: May 9, 2012
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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.

Related Conditions & MeSH terms

• Wound Infection
• Wounds and Injuries

Intervention

Other:
• Infected
Extremity wound, infected
• Not infected
Extremity wounds, non-infected

Locations

Country	Name	City	State
Pakistan	International Committee of the Red Cross hospital	Peshawar	Khyber Pakhtunkhwa

Sponsors (2)

Lead Sponsor	Collaborator
Karolinska Institutet	The International Federation of Red Cross and Red Crescent Societies

Country where clinical trial is conducted

Pakistan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Amputation	In-hospital extremity amputation. Upper or lower extremity, all levels.	From hospital admission to discharge, an average of 15 days
Secondary	Death	In-hospital death	From hospital admission to discharge, an average of 15 days