Using Negative Pressure Therapy to Prevent Infections After Major Amputations
Prophylactic Single-Use Negative Pressure Wound Therapy Devices for Closed Incision Major Amputations
This study is testing if special dressings that use negative pressure can help prevent infections and improve healing for people who have had major leg amputations.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 728 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Royal College of Surgeons, Ireland Academic / other |
| Locations | 7 sites (Dublin and 6 other locations) |
| Trial ID | NCT06025253 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older who are scheduled for major lower extremity amputations with primary closure of the surgical incision.
Not a fit: Patients under 18, pregnant or breastfeeding women, and those with specific types of amputations that do not allow for primary skin closure will not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly reduce the risk of infections and improve healing outcomes for patients undergoing major amputations.
How similar studies have performed: Previous studies have shown promising results with Negative Pressure Wound Therapy in similar contexts, indicating potential for success in this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
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 this trial is running
Dublin and 6 other locations
- Beaumont Hospital, Beaumont rd,Dublin 9, D09V2N0 — Dublin, Ireland (Not_yet_recruiting)
- St Jamess Hospital — Dublin, Ireland (Not_yet_recruiting)
- St Vincents University Hospital — Dublin, Ireland (Not_yet_recruiting)
- Tallaght University Hospital — Dublin, Ireland (Not_yet_recruiting)
- University Hospital Galway — Galway, Ireland (Recruiting)
- University Hospital Limerick — Limerick, Ireland (Not_yet_recruiting)
- University Hospital Waterford — Waterford, 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.