Status:
RECRUITING
PINTA - Prophylactic Incisional Negative Pressure Therapy for Major Amputations
Lead Sponsor:
Royal College of Surgeons, Ireland
Conditions:
Wound Surgical
Wound Infection
Eligibility:
All Genders
18+ years
Phase:
NA
Brief 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 Su...
Detailed Description
Many factors influence the risk of wound complications. Notably, the presence of unreconstructed proximal occlusive arterial disease is a major influence on stump healing. Patient factors such as smok...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
March 1 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 20 2026
Estimated Enrollment :
728 Patients enrolled
Trial Details
Trial ID
NCT06025253
Start Date
March 1 2024
End Date
December 20 2026
Last Update
October 18 2024
Active Locations (7)
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1
Beaumont Hospital, Beaumont rd,Dublin 9, D09V2N0
Dublin, Ireland, H91 YR71
2
St Jamess Hospital
Dublin, Ireland
3
St Vincents University Hospital
Dublin, Ireland
4
Tallaght University Hospital
Dublin, Ireland