Using Negative Pressure Therapy to Prevent Infections After Major Amputations

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study investigates the effectiveness of Negative Pressure Wound Therapy (NPWT) dressings in reducing surgical site infections and improving scar appearance compared to standard dressings in patients undergoing major lower extremity amputations. It aims to address post-operative wound complications that significantly affect patient outcomes. The trial will be multicenter and randomized, focusing on patients with closed incisions following major amputations. The study will evaluate the incidence of surgical site infections, wound healing complications, and the overall impact on patient quality of life and healthcare costs.

Why it matters

Who can join: the full rules

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

Where it's running

• Beaumont Hospital, Beaumont Rd,Dublin 9, D09V2N0
  Dublin, Dublin, Ireland 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

Study contacts

• Principal investigator: Stewart Walsh, Prof — University Hospital Galway (UHG)
• Study coordinator: Stewart Walsh
• Email: stewartredmond.walsh@universityofgalway.ie
• Phone: 353 915 2422

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.