Actively Recruiting
Negative Pressure Wound Therapy in Renal Transplant - NEWER Trial
Led by Centro Hospitalar De São João, E.P.E. · Updated on 2025-07-15
150
Participants Needed
1
Research Sites
4 weeks
Total Duration
On this page
Sponsors
C
Centro Hospitalar De São João, E.P.E.
Lead Sponsor
U
Universidade do Porto
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are studying patients undergoing open kidney transplant surgery to compare two different wound care methods. This research aims to evaluate negative pressure wound therapy (NPWT) against standard wound dressings to see how each affects wound healing and complications after transplant. The study is conducted prospectively and involves adult transplant recipients, excluding pediatric patients and those needing additional surgery within three months. Participants are randomly assigned to either receive NPWT using the PICO device applied during surgery at 80 mmHg pressure for seven days or standard wound dressings. Wound healing and complications are assessed over time, with evaluations at 7, 14, 30, and 90 days after surgery. If the wound opens, it is classified based on depth. Pain levels, infection signs, quality of life, and scar healing are also monitored using established scoring tools. During the study, participants will undergo regular wound checks, infection assessments, and complete questionnaires about pain and quality of life related to their surgical incision. Scar healing is specifically evaluated at 30 and 90 days post-operation. The main outcome measured is wound opening within the first 90 days, along with secondary outcomes like infection, pain, quality of life, and scar condition. The study runs from January 2023 through mid-2026, with ongoing safety and healing monitoring throughout the follow-up periods.
CONDITIONS
Brief Title
NEgative prEssure Wound Therapy in Renal Transplant
Who Can Participate
Eligibility Criteria
You may qualify if you...
- All patients submitted to kidney transplant
You will not qualify if you...
- Pediatric patients
- Patients requiring surgical reinterventions within the first 90 days postoperative
- Patients allergic to NPWT components
- Orthotopic transplant patients
AI-Screening
AI-Powered Screening
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Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Duration - 7 days
Participants undergo open renal transplant surgery with wound therapy applied intraoperatively.
1 hospital stay with wound therapy applied during surgery and maintained for 7 days
Duration - 90 days
Participants have wound evaluations and assessments for infection, pain, quality of life, and scar healing.
Visits at 7, 14, 30, and 90 days post-operatively
Trial Site Locations
Total: 1 location
1
São João University Hospital
Porto, Portugal
Actively Recruiting
Research Team
A
Alberto Silva, MD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
PREVENTION
Number of Arms
2
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