Peculiarities of Pain in Patients With Mine-explosive Wounds Depending on the Localization of the Wound at the Stages of Treatment (PPPM-EWDL)

Mine-explosive wounds in the general structure of combat sanitary losses reach 25%. They are characterized by significant damage resulting in high intensity pain. In patients who received mine-explosive injuries in the conditions of hostilities, such pain has its own unique features. It is necessary to pay more attention to the problem of pain treatment in patients of this category, because about 87.2% of cases have negative results of treatment - it becomes chronic.

Study Overview

• Status: Completed
• Conditions: Chronic Pain
• Intervention / Treatment: Other: visual analog scale

Detailed Description

Over the last ten years, the amount of pathology caused by mine-explosive devices has increased significantly. Mine-explosive wounds in the general structure of combat sanitary losses reach 25%. They often have a combined character. Such an injury must be considered as a multifactorial injury resulting from the combined impact on a person of a shock wave, gas jets, flames, toxic products, fragments of the hull, secondary projectiles, which cause severe injuries in the area of direct damage and the body as a whole. Mine-explosive injuries are characterized by multiple, combined or combined injuries with a high degree of severity - 8-10%. Also, even in peacetime, terrorists often use powerful explosive devices. Here, the mortality rate is 10-20% of the total number of injured, and 80-90% suffer from the consequences - mine-explosive injuries. Compared to the wars of the past, the number of seriously wounded with combined injuries has increased to 25-30%. This is primarily due to the use of high-precision ammunition and mine-explosive ammunition. In general, multiple and combined damage in local conflicts today is 25-62%. Lethality in case of mine-explosive injury reaches 37-41.4%. The mortality rate among the wounded with mine-explosive injuries who were admitted to the stage of qualified medical care was 17.4%, more than half of the wounded died as a result of blood loss. In 63.7%, death occurs in the first 24 hours after injury.The direct and most frequent causes are shock and blood loss (49.1%), destruction of vital organs (28.4%). About 90% of all combat deaths occur before the wounded reaches the first stage of treatment.

The peculiarities of pain in patients with mine-explosive wounds depending on the localization of the wound at the stages of treatment need to be studied, because the subjective feelings and emotional experiences experienced by patients during the wounding in combat conditions through the prism of psychological disorders have their own characteristics. Since in 87.2% of cases it is not possible to achieve a positive result of treatment, the data of our study will play an important role in their treatment.

• Study Type: Observational
• Enrollment (Actual): 660

Contacts and Locations

Study Locations

• Ukraine
  • Kyiv, Ukraine
    • Bogomolets National Medical University, Ministry of Health of Ukraine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Probability Sample

Study Population

all patients were injured during hostilities

Description

Inclusion Criteria:

• the presence of gunshot wounds

Exclusion Criteria:

• no gunshot wounds

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
retrospective analysis; A retrospective analysis of disease histories for the period from 2014 to 2021 was carried out. Data collection was carried out at all stages of treatment: medical and nursing brigade, military mobile hospital, military medical clinical center, during rehabilitation, within 12 months of the injury.	Other: visual analog scale; Data collection was carried out at all stages of treatment: medical and nursing brigade, military mobile hospital, military medical clinical center, during rehabilitation, within 12 months of the injury.; Other Names: Chaban Quality of Life Scale; The Hospital Anxiety and Depression Scale (HADS); Mississippi PTSD scale (military version); neuropathic pain Didier Bouhassiraa (DN4).
prospective study; Recruitment of patients for the prospective study was carried out in the period from 02.24.2022 to 05.24.2022	Other: visual analog scale; Data collection was carried out at all stages of treatment: medical and nursing brigade, military mobile hospital, military medical clinical center, during rehabilitation, within 12 months of the injury.; Other Names: Chaban Quality of Life Scale; The Hospital Anxiety and Depression Scale (HADS); Mississippi PTSD scale (military version); neuropathic pain Didier Bouhassiraa (DN4).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
visual analog scale	from 0 to 10 points	12 months
The Hospital Anxiety and Depression Scale	0-7 is the norm 8-13 - mild depressive disorders 14-18 - depressive disorders of medium severity 19-22 - severe depressive disorders 23 and more - depressive disorders of a very severe degree of severity	12 months
Chaban Quality of Life Scale	up to 56 inclusive - a very low level 57-66 - low 67-75 - average 76-82 - tall 83-100 is very high	12 months
Mississippi PTSD scale (military version)	the mean values of the total score are 76±18 for well-adjusted servicemen, 86±26 for servicemen with mental disorders, and 130±18 for those with PTSD	12 months
Didier Bouhassiraa DN4	4 or more points (a neuropathic pain component is present)	12 months

Collaborators and Investigators

• Sponsor: Bogomolets National Medical University

Study record dates

Study Major Dates

• Study Start (Actual): February 24, 2022
• Primary Completion (Actual): May 24, 2022
• Study Completion (Actual): May 24, 2022

Study Registration Dates

• First Submitted: August 1, 2022
• First Submitted That Met QC Criteria: August 2, 2022
• First Posted (Actual): August 3, 2022

Study Record Updates

• Last Update Posted (Actual): July 27, 2023
• Last Update Submitted That Met QC Criteria: July 25, 2023
• Last Verified: July 1, 2023

More Information

Terms related to this study

• Keywords: pain, wounds, stages of treatment
• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Chronic Pain
• Other Study ID Numbers: №158 (23.05.2022)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED
• IPD Plan Description: I plan to share

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No