Phantom Limb Pain After AmputationNPWT-Pain StudNCT07475897
Negative Pressure Wound Therapy as a Predictor of Persistent Pain After War-Related Trauma
An observational study of Phantom Limb Pain After Amputation and Chronic Pain Due to Injury, run by Charitable Organisation Charitable Fund Superhumans (Co Cf Superhumans) at 1 site in Ukraine.
Trial summary
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). Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Phantom Limb Pain After Amputation, Chronic Pain Due to Injury, Postoperative Pain
- How many people
- 150 participants
- Where
- 1 siteUkraine
- Study dates
- 15 Mar 2026to 15 Mar 2026
- 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 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
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.
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Phantom Limb Pain After Amputation, Chronic Pain Due to Injury, Postoperative Pain, Trauma (Including Fractures), Amputation Stump, Amputation Stump; Infection
- Keywords
- Negative Pressure Wound Therapy, War-related trauma, Post-traumatic pain, Neuropathic pain, Chronic pain after trauma, Soft tissue injury
- Medical subject headings
- Pain, Postoperative, Wounds and Injuries, Infections, War-Related Injuries, Neuralgia, Soft Tissue Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 being measured
The primary outcome is the main question the study is designed to answer.
Persistent Post-Traumatic Pain
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.
Measured: 6 months after injury
Secondary outcomes (2)
Pain Intensity
Pain intensity in the injured region measured using the Numeric Rating Scale (NRS, 0-10).
Measured: 3 months and 6 months after injury.
Paresthesia
Presence of abnormal sensory sensations such as tingling, numbness, or pins-and-needles in the injured region.
Measured: 3 months and 6 months after injury.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Mar 2026
- Study start15 Mar 2026
- Primary completion15 Mar 2026
- Study completion15 Mar 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Phantom Limb Pain After AmputationStudies of the same condition, open and under way.
- 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
- 150 participants (actual)
Sponsor and investigators
- Lead sponsor
- Charitable Organisation Charitable Fund Superhumans (Co Cf Superhumans)
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dmytro Dmytriiev, Charitable Organisation Charitable Fund Superhumans (Co Cf Superhumans)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07475897
- Sponsor's protocol ID
- 130303032026
- Other IDs
- Superhumans war trauma center
- Acronym
- NPWT-Pain Stud
- Status last verified
- Oct 2026
- First submitted
- 13 Mar 2026
- Last updated
- 23 Oct 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: 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.
Publications
Stannard JP, Volgas DA, Stewart R, McGwin G Jr, Alonso JE. Negative pressure wound therapy after severe open fractures: a prospective randomized study. J Orthop Trauma. 2009 Sep;23(8):552-7. doi: 10.1097/BOT.0b013e3181a2e2b6.
PubMed 19704269
Study at a glance
From the registry record, last updated by the sponsor on 23 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Negative Pressure Wound Therapy as a Predictor of Persistent Pain After War-Related Trauma: A Prospective Cohort Study
- ClinicalTrials.gov ID
- NCT07475897
- Acronym / sponsor ID
- NPWT-Pain Stud / 130303032026
- Conditions
- Phantom Limb Pain After Amputation, Chronic Pain Due to Injury, Postoperative Pain, Trauma (Including Fractures), Amputation Stump, Amputation Stump; Infection
- Keywords
- Negative Pressure Wound Therapy, War-related trauma, Post-traumatic pain, Neuropathic pain, Chronic pain after trauma, Soft tissue injury
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 150 participants (actual)
- Lead sponsor
- Charitable Organisation Charitable Fund Superhumans (Co Cf Superhumans)University, hospital or other
- Study start
- 15 Mar 2026 (actual)
- Primary completion
- 15 Mar 2026 (actual)
- Study completion
- 15 Mar 2026 (actual)
- First posted
- 17 Mar 2026 (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.
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.
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 design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- 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.
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
2 secondary outcomes
Pain Intensity
Time frame: 3 months and 6 months after injury.
Paresthesia
Time frame: 3 months and 6 months after injury.
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 23 Oct 2026.
- Results publication: PubMed 19704269Stannard JP, Volgas DA, Stewart R, McGwin G Jr, Alonso JE. Negative pressure wound therapy after severe open fractures: a prospective randomized study. J Orthop Trauma. 2009 Sep;23(8):552-7. doi: 10.1097/BOT.0b013e3181a2e2b6.
- Individual participant dataSharing planned: No. 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.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Phantom Limb Pain After Amputation and Chronic Pain Due to Injury, run by Charitable Organisation Charitable Fund Superhumans (Co Cf Superhumans) at 1 site in Ukraine.
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 5 inclusion and 5 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 23 Oct 2026. 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 Ukraine. 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?
Persistent Post-Traumatic Pain (time frame: 6 months after injury). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07475897, which also lists 1 linked publication.
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 23 Oct 2026; AzTrials last refreshed its copy on 26 Oct 2026.