Negative Pressure Wound Therapy as a Predictor of Persistent Pain After War-Related Trauma (NPWT-Pain Stud)

March 16, 2026 updated by: Dmytro Dmytriiev, Charitable Organisation Charitable Fund Superhumans (Co Cf Superhumans)

Negative Pressure Wound Therapy as a Predictor of Persistent Pain After War-Related Trauma: A Prospective Cohort Study

War-related trauma frequently causes complex soft tissue injuries that require repeated surgical treatment and advanced wound management techniques such as Negative Pressure Wound Therapy (NPWT). Although NPWT is widely used to promote wound healing and prepare wounds for reconstruction, its relationship with long-term pain outcomes remains unclear.

This prospective cohort study aims to investigate whether the use of NPWT after war-related trauma is associated with an increased risk of persistent post-traumatic pain six months after injury. Adult patients with traumatic soft tissue injuries requiring surgical management will be enrolled and followed for six months.

In addition to NPWT exposure, the study will evaluate several early clinical predictors of chronic pain, including acute pain intensity, number of surgical debridements, suspected nerve injury, and mechanism of trauma. Understanding these predictors may help clinicians identify high-risk patients early and develop targeted strategies for pain prevention and rehabilitation after severe trauma.

Study Overview

Status

Not yet recruiting

Conditions

Detailed Description

War-related trauma frequently produces complex soft tissue injuries requiring staged surgical management, repeated debridement procedures, and advanced wound care strategies. Negative Pressure Wound Therapy (NPWT) has become a widely used technique in modern trauma care to improve wound healing, control exudate, reduce edema, and prepare wounds for delayed closure or reconstruction. In patients with severe trauma, NPWT is commonly applied following surgical debridement and may be used for several days or weeks depending on wound severity and healing progress.

Although NPWT has well-established benefits in wound management, its relationship with long-term pain outcomes has not been clearly defined. Patients with severe traumatic injuries are at increased risk of developing persistent post-traumatic pain due to extensive tissue damage, repeated surgical interventions, inflammation, and potential peripheral nerve injury. Early clinical factors such as high acute pain intensity, nerve involvement, and repeated surgical manipulation may contribute to peripheral and central sensitization, ultimately increasing the risk of chronic pain.

In trauma populations, NPWT may represent not only a treatment modality but also a clinical marker of injury severity, prolonged wound healing, and repeated surgical procedures. Therefore, evaluating the relationship between NPWT exposure and long-term pain outcomes may help identify patients at higher risk for persistent post-traumatic pain.

This prospective observational cohort study will enroll adult patients with war-related traumatic injuries requiring surgical wound management. Participants will be classified according to whether they received NPWT during their wound treatment. Clinical data related to injury characteristics, early pain intensity, surgical management, and suspected nerve injury will be recorded.

Participants will be followed for six months after injury to assess the development of persistent pain, neuropathic pain symptoms, paresthesia, and pain interference with daily activities. The study will also explore early clinical predictors of chronic pain, including the use and duration of NPWT, number of surgical procedures, acute pain intensity during the first 72 hours after injury, suspected nerve injury, and mechanism of trauma.

By identifying factors associated with persistent post-traumatic pain, this study may improve risk stratification and support the development of early pain prevention and rehabilitation strategies for patients with severe traumatic injuries.

Study Type

Observational

Enrollment (Estimated)

150

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Ukraine
      • Lviv, Ukraine
        • Superhumans War Trauma Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

The study population will include adult patients (≥18 years) with war-related traumatic soft tissue injuries requiring surgical wound management. Participants will be recruited from trauma centers treating combat-related injuries such as blast injuries, fragmentation wounds, gunshot wounds, burns, and crush trauma. Patients may receive Negative Pressure Wound Therapy (NPWT) or standard wound care as part of routine clinical treatment. All participants will be followed prospectively to assess pain outcomes and sensory symptoms for up to 6 months after injury.

Description

Inclusion Criteria:

  • age ≥18 years
  • war-related trauma (blast injury, fragmentation injury, gunshot wound, burn injury, or crush injury)
  • traumatic soft tissue injury requiring surgical management
  • ability to provide informed consent
  • availability for follow-up assessments

Exclusion Criteria:

  • chronic pain in the same anatomical region prior to injury
  • severe cognitive impairment preventing pain assessment
  • inability to communicate or complete questionnaires
  • refusal to participate
  • incomplete baseline data or loss to follow-up

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
War-Related Trauma With Surgical Wound Management
This cohort includes adult patients with war-related traumatic soft tissue injuries requiring surgical wound management. Patients may receive Negative Pressure Wound Therapy (NPWT) or standard wound care as part of routine clinical treatment. The study is observational and does not mandate any intervention. The primary exposure of interest is the use and duration of NPWT, and participants will be followed prospectively to assess the development of persistent post-traumatic pain and related sensory symptoms up to 6 months after injury.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Persistent Post-Traumatic Pain
Time Frame: 6 months after injury
Presence of persistent pain in the injured anatomical region defined as pain intensity ≥3 on a 0-10 Numeric Rating Scale (NRS) at 6 months after trauma. Pain will be assessed during follow-up using the standardized Numeric Rating Scale.
6 months after injury

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pain Intensity
Time Frame: 3 months and 6 months after injury.
Pain intensity in the injured region measured using the Numeric Rating Scale (NRS, 0-10).
3 months and 6 months after injury.
Paresthesia
Time Frame: 3 months and 6 months after injury.
Presence of abnormal sensory sensations such as tingling, numbness, or pins-and-needles in the injured region.
3 months and 6 months after injury.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Charitable Organisation Charitable Fund Superhumans (Co Cf Superhumans)

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

March 15, 2026

Primary Completion (Estimated)

March 15, 2026

Study Completion (Estimated)

March 15, 2026

Study Registration Dates

First Submitted

March 13, 2026

First Submitted That Met QC Criteria

March 13, 2026

First Posted (Actual)

March 17, 2026

Study Record Updates

Last Update Posted (Actual)

March 18, 2026

Last Update Submitted That Met QC Criteria

March 16, 2026

Last Verified

March 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 130303032026
  • Superhumans war trauma center (Other Identifier: Superhumans war trauma center)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Individual participant data (IPD) will not be publicly shared due to ethical and legal considerations related to sensitive clinical data from patients with war-related trauma. The dataset may contain potentially identifiable health information and details associated with combat injuries. De-identified aggregated data may be made available upon reasonable request to the study investigators and subject to approval by the institutional ethics committee and applicable data protection regulations.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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