Post-Amputation Stump Infection as a Predictor of Persistent Residual Limb Pain: A Prospective Cohort Study

Persistent residual limb pain is common after traumatic amputation and significantly impairs rehabilitation and prosthetic use. Postoperative stump infection may contribute to peripheral nerve sensitization, scar fibrosis, and long-term pain persistence. This prospective cohort study aims to determine whether early post-amputation stump infection independently predicts persistent clinically significant residual limb pain at 3 and 6 months after surgery.

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Key information

Conditions

Residual Limb Pain Amputation, Traumatic Barotrauma Blast Injuries Chronic Pain Infections Nervous System Diseases Neuralgia Neurobehavioral Manifestations Neurologic Manifestations Neuromuscular Diseases Pain Pain, Postoperative Pathologic Processes Pathological Conditions, Signs and Symptoms Perceptual Disorders Peripheral Nervous System Diseases Phantom Limb Phantom Limb Pain (PLP) Post-Amputation Pain Postoperative Complications Signs and Symptoms Stump Pain Surgical Site Infection Surgical Wound Infection Wound Infection Wounds and Injuries

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Observational

About this study

Patients undergoing traumatic limb amputation will be enrolled within 4 weeks after surgery and followed for 6 months. Early postoperative stump infection will be recorded using predefined clinical criteria. Pain intensity (Numeric Rating Scale), neuropathic pain screening (DN4), and phantom limb pain will be assessed at baseline, 3 months, and 6 months. Multivariable logistic regression will be used to evaluate whether stump infection is independently associated with persistent residual limb pain, adjusting for amputation level, injury mechanism, revision surgeries, antibiotic exposure, and demographic factors.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Traumatic upper or lower limb amputation
Enrollment within 4 weeks after surgery
Ability to provide informed consent

Exclusion criteria

Pre-existing chronic pain in the affected limb
Severe cognitive impairment
Terminal illness limiting follow-up
Refusal or inability to complete follow-up assessments

Treatment and study plan

Primary outcomes

Persistent Clinically Significant Residual Limb Pain

Time frame: 3 months

Presence of clinically significant residual limb pain defined as Numeric Rating Scale (NRS) ≥4 at rest or during movement at 3 months after amputation.

Secondary outcomes

Persistent Residual Limb Pain at 6 Months

Time frame: 6 months

NRS ≥4 at rest or during movement at 6 months after amputation.

Study contacts

Contact information is provided by the study sponsor or research team.

Dmytro Dmytriiev, PhD.Professor

CONTACT

[email protected]

+380674309449

Sponsors and collaborators

Lead sponsor

Ukrainian Society of Regional Anesthesia and Pain Therapy

Other

Registry information

Acronym: INF-STUMP-PAIN

Important dates

Study start: 2026
Primary completion: 2026
Study completion: 2026
First posted: Feb 27, 2026
Registry last updated: Jun 3, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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