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

NCT07438795 | Not Yet Recruiting

• 2 other identifiers: 23V0223022026USRA
• Study Type: observational
• Target: 150
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Residual Limb Pain; Stump Pain; Post-Amputation Pain; Surgical Site Infection; Phantom Limb Pain (PLP)

Keywords

Traumatic amputation; stump infection; residual limb pain; chronic pain; surgical site infection; blast injury; neuropathic pain

Outcome Measures

Primary Outcomes (1)

• Persistent Clinically Significant Residual Limb Pain

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

  3 months

Secondary Outcomes (1)

• Persistent Residual Limb Pain at 6 Months

  6 months

Study Arms (1)

Stump Infection

Participants who develop postoperative stump infection within 30 days after amputation, defined by clinical signs of infection requiring antibiotic therapy and/or surgical revision.

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

The study population will consist of adult patients (≥18 years) undergoing traumatic upper or lower limb amputation following blast-related, drone-related, or other high-energy injuries. Participants will be enrolled within 4 weeks after primary amputation surgery and followed prospectively for 6 months. The population represents individuals at risk of developing persistent residual limb pain during the early postoperative and rehabilitation period.

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Ukrainian Society of Regional Anesthesia and Pain Therapy: lead

MeSH Terms

Conditions

Surgical Wound Infection; Phantom Limb; Amputation, Traumatic; Chronic Pain; Blast Injuries; Neuralgia

Condition Hierarchy (Ancestors)

Wound Infection; Infections; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Perceptual Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Pain, Postoperative; Signs and Symptoms; Pain; Wounds and Injuries; Barotrauma; Peripheral Nervous System Diseases; Neuromuscular Diseases

Central Study Contacts

Dmytro Dmytriiev, PhD.Professor

CONTACT

+380674309449; mddmytriiev@gmail.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 6 Months
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: professor

Study Record Dates

• First Submitted: February 22, 2026
• First Posted: February 27, 2026
• Study Start (Estimated): June 23, 2026
• Primary Completion (Estimated): June 23, 2026
• Study Completion (Estimated): December 23, 2026
• Last Updated: June 3, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will not share