RecruitingNot ApplicableNCT06025253

PINTA - Prophylactic Incisional Negative Pressure Therapy for Major Amputations

Prophylactic Single-Use Negative Pressure Wound Therapy Devices for Closed Incision Major Amputations


Sponsor

Royal College of Surgeons, Ireland

Enrollment

728 participants

Start Date

Mar 1, 2024

Study Type

INTERVENTIONAL

Conditions

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

Min Age: 18 Years

Inclusion Criteria3

  • 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 Criteria5

  • 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

Interested in this trial?

Get notified about updates and connect with the research team.

Interventions

DEVICENegative Pressure Wound Therapy

Application of negative-pressure wound therapy (NPWT) post major lower extremity amputation

DEVICEStandard Wound Dressing

Application of standard wound dressing post major lower extremity amputation


Locations(7)

Beaumont Hospital, Beaumont rd,Dublin 9, D09V2N0

Dublin, Ireland

St Jamess 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

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

Visit

NCT06025253


Related Trials