Wounds and InjuriesNCT03463720
Outcome for Patients With War-Associated Extremity Wound Infection
An observational study of Wounds and Injuries, run by Karolinska Institutet at 1 site in Pakistan.
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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Wounds and Injuries
- What is being tested?
- Infected and Not infected
- How many people
- 843 participants
- Where
- 1 sitePakistan
- Study dates
- 27 Sep 2010to 9 May 2012
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Consecutive patients treated at the hospital in Peshawar between September 27, 2010 and May 9, 2012 that meet eligibility criteria.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Pakistan1 site
International Committee of the Red Cross hospital
Peshawar, Khyber Pakhtunkhwa
About this study
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.
Read the 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
- Being tested
- Infected, Not infected
- Medical subject headings
- Wounds and Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
InfectedOther
Extremity wound, infected
Not infectedOther
Extremity wounds, non-infected
| Study group | Role | What they receive |
|---|---|---|
| Extremity wound | Patients with extremity wounds. Infected and not infected patients will be compared. Receives: Other: Infected; Other: Not infected |
What is being measured
The primary outcome is the main question the study is designed to answer.
Amputation
In-hospital extremity amputation. Upper or lower extremity, all levels.
Measured: From hospital admission to discharge, an average of 15 days
Secondary outcomes (1)
Death
In-hospital death
Measured: From hospital admission to discharge, an average of 15 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Mar 2018
- Study start27 Sep 2010
- Primary completion9 May 2012
- Study completion9 May 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Wounds and InjuriesStudies of the same condition, open and under way.
- More trials run by Karolinska InstitutetThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 843 participants (actual)
Sponsor and investigators
- Lead sponsor
- Karolinska Institutet
- Sponsor type
- University, hospital or other
- Collaborators
- The International Federation of Red Cross and Red Crescent Societies
- Responsible party
- Principal investigator, Jonas Malmstedt, Karolinska Institutet
- Investigators
- Jonas Malmstedt, PhD, Principal investigator, Karolinska Institutet
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03463720
- Sponsor's protocol ID
- KISOS003
- Status last verified
- Feb 2018
- First submitted
- 22 Feb 2018
- Last updated
- 13 Mar 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: The use of identification numbers will ensure anonymity of the data. All data will remain confidential throughout the data entry and analysis process by encryption. Individual patient data will not be distributed outside the study location, or appear in any report or publication.
Study at a glance
From the registry record, last updated by the sponsor on 13 Mar 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Outcome for Patients With War-Associated Extremity Wound Infection
- ClinicalTrials.gov ID
- NCT03463720
- Acronym / sponsor ID
- KISOS003
- Conditions
- Wounds and Injuries
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 843 participants (actual)
- Lead sponsor
- Karolinska InstitutetUniversity, hospital or other
- Collaborators
- The International Federation of Red Cross and Red Crescent Societies
- Study start
- 27 Sep 2010 (actual)
- Primary completion
- 9 May 2012 (actual)
- Study completion
- 9 May 2012 (actual)
- First posted
- 13 Mar 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Extremity wound | – | Other: Infected, Other: Not infectedPatients with extremity wounds. Infected and not infected patients will be compared. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Consecutive patients treated at the hospital in Peshawar between September 27, 2010 and May 9, 2012 that meet eligibility criteria.
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (1 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| InfectedExtremity wound, infected | Other | Extremity wound |
| Not infectedExtremity wounds, non-infected | Other | Extremity wound |
Primary outcome
Amputation
Time frame: From hospital admission to discharge, an average of 15 days
In-hospital extremity amputation. Upper or lower extremity, all levels.
1 secondary outcome
Death
Time frame: From hospital admission to discharge, an average of 15 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Mar 2018.
- Individual participant dataSharing planned: No. The use of identification numbers will ensure anonymity of the data. All data will remain confidential throughout the data entry and analysis process by encryption. Individual patient data will not be distributed outside the study location, or appear in any report or publication.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jonas Malmstedt, PhD principal investigator
Karolinska Institutet
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Wounds and Injuries, run by Karolinska Institutet at 1 site in Pakistan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Mar 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Pakistan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Amputation (time frame: From hospital admission to discharge, an average of 15 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Mar 2018.