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

Status

Not yet recruiting

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT07438795

Acronym

INF-STUMP-PAIN

Enrollment

150

Registered

2026-02-27

Start date

2026-06-23

Completion date

2026-12-23

Last updated

2026-06-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

Keywords

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

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.

Detailed description

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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to 60 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
Persistent Clinically Significant Residual Limb Pain	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

Measure	Time frame	Description
Persistent Residual Limb Pain at 6 Months	6 months	NRS ≥4 at rest or during movement at 6 months after amputation.

Contacts

CONTACTDmytro Dmytriiev, PhD.Professor

mddmytriiev@gmail.com+380674309449

Outcome results