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

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)

Facility	City	Region	Status
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

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