Outcome for Patients With War-Associated Extremity Wound Infection

NCT03463720 | Completed

• 1 other identifier: KISOS003
• Study Type: observational
• Target: 843
• Locations: 1 country
• Sites: 1

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.

Conditions

Wounds and Injuries

Outcome Measures

Primary Outcomes (1)

• Amputation

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

  From hospital admission to discharge, an average of 15 days

Secondary Outcomes (1)

• Death

  From hospital admission to discharge, an average of 15 days

Study Arms (1)

Extremity wound

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

Other: Infected; Other: Not infected

Interventions

Infected OTHER

Extremity wound, infected

Extremity wound

Not infected OTHER

Extremity wounds, non-infected

Extremity wound

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

Consecutive patients treated at the hospital in Peshawar between September 27, 2010 and May 9, 2012 that meet eligibility criteria.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Karolinska Institutet: lead
• The International Federation of Red Cross and Red Crescent Societies: collaborator

Study Sites (1)

International Committee of the Red Cross hospital

Peshawar, Khyber Pakhtunkhwa, Pakistan

Location

MeSH Terms

Conditions

Wounds and Injuries

Study Officials

• Jonas Malmstedt, PhD

  Karolinska Institutet

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: February 22, 2018
• First Posted: March 13, 2018
• Study Start: September 27, 2010
• Primary Completion: May 9, 2012
• Study Completion: May 9, 2012
• Last Updated: March 13, 2018

Record last verified: 2018-02

Data Sharing

• IPD Sharing: Will not share

Locations

PA (1)