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PINTA - Prophylactic Incisional Negative Pressure Therapy for Major Amputations

RecruitingNAAges 18 Years - anyAllRoyal College of Surgeons, Ireland
NCT06025253 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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.

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📋 Eligibility rules (as published)
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
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What it tests

  • Negative Pressure Wound Therapy
  • Standard Wound Dressing
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Where

7 sites
Beaumont Hospital, Beaumont Rd,Dublin 9, D09V2N0
Dublin, Ireland
St James's Hospital
Dublin, Ireland
St Vincents University Hospital
Dublin, Ireland
Tallaght University Hospital
Dublin, Ireland
University Hospital Galway
Galway, Ireland
University Hospital Limerick
Limerick, Ireland
University Hospital Waterford
Waterford, Ireland
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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