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Clinical Trials in Ireland / NCT06025253
Recruiting Not applicable

PINTA - Prophylactic Incisional Negative Pressure Therapy for Major Amputations

NCT06025253 · tracked via the Priya Life Science Ireland tracker
Sponsor
Royal College of Surgeons, Ireland
Phase
Not applicable
Started
2024-03-01
Last updated
2026-07-21

Condition(s) studied

Wound SurgicalWound InfectionCosmesis

Investigational drug(s) / intervention(s)

Negative Pressure Wound TherapyStandard Wound Dressing

Negative Pressure Wound Therapy: Application of negative-pressure wound therapy (NPWT) post major lower extremity amputation

Standard Wound Dressing: Application of standard wound dressing post major lower extremity amputation

Study summary

Post-operative wound issues in abdominal surgery have a significant impact on patient outcomes. This study is taking place to investigate if Negative Pressure Wound Therapy (NPWT) dressings reduces Surgical Site Infections, post surgical complications and improves scar appearance compared to standard dressings.

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria: * Patients aged 18 years or older; * Patients undergoing major lower extremity amputation, including below-knee amputation, through-knee amputation and above-knee amputation, for any indication; * Patients with primary closure of the surgical incision using either interrupted or continuous sutures Exclusion Criteria: * Patients \<18 years; * Women who are pregnant and/or breast-feeding; * Patients with amputations performed without primary skin closure, including guillotine amputations, amputations deliberately left open for drainage purposes and amputations with soft tissues defects at the stump; * Patients with amputations where skin glue is the only means of skin closure * Patients with a clinically absent femoral pulse

Primary outcome measure(s)

  • Presence of wound complications following amputation between NPWT and standard dressings — 1 month following surgery
    Infection(deep or superficial), wound dehiscence, partial (fascia intact), complete (fascia breached), seroma, haematoma or stump necrosis.

Trial sites (7)

FacilityCityRegionStatus
Beaumont Hospital, Beaumont Rd,Dublin 9, D09V2N0 Dublin Dublin Recruiting
St James's Hospital Dublin Ireland Recruiting
St Vincents University Hospital Dublin Ireland Recruiting
Tallaght University Hospital Dublin Ireland Recruiting
University Hospital Galway Galway Ireland Recruiting
University Hospital Limerick Limerick Ireland Recruiting
University Hospital Waterford Waterford Ireland Recruiting

More Royal College of Surgeons, Ireland trials in Ireland

The ACHILLS Trial; Application of Cerament in Heel Infection for Lower Limb Salvage Recruiting
SURVEY-CNS: A Feasibility Study of Randomising Women and Men With HER2-Positive Metastatic Breast Cancer to Central Nervous System Surveillance Versus No Surveillance Recruiting
ENVELOP: Wound Care Following Pilonidal Sinus Surgery Recruiting
The PHARO Trial: The Incidence of Para-conduit Hernia With Closure of Hiatus Versus the Standard Approach in Robotic Oesophagectomy - A Randomised Controlled Pilot Trial Recruiting
Mindful-Med: the Evaluation of the Mindfulness-based Stress-coping and Burnout Prevention Programme for Medical Interns. Active, not recruiting

Other trials for the same condition

PROPEL-2: Prophylactic Negative Pressure Wound Therapy in Laparotomy Wounds Active, not recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06025253 on ClinicalTrials.gov ↗ ← All trials in Ireland