Negative-pressure wound dressing after kidney transplant
NEgative prEssure Wound Therapy in Renal Transplant - NEWER Trial
This study tests whether using a negative-pressure wound dressing right after open kidney transplant reduces wound problems for adult transplant recipients.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Enrollment | 150 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Centro Hospitalar De São João, E.P.E. Academic / other |
| Locations | 1 site (Porto) |
| Trial ID | NCT07065734 on ClinicalTrials.gov |
What this trial studies
This prospective, randomized Phase 4 trial enrolled adults undergoing open kidney transplant between January 2023 and August 2024 and assigned them to either intraoperative negative-pressure wound therapy (NPWT) with PICO (Smith & Nephew) at 80 mmHg for 7 days or to standard wound dressings. Pediatric patients, those needing surgical reintervention within 90 days, patients allergic to NPWT components, and orthotopic transplants were excluded. Wounds were evaluated at 7, 14, 30, and 90 days for dehiscence (classified as superficial or deep), infection using the ASEPSIS score, pain by visual analogue scale, quality of life by EQ-5D, and scar healing by POSAS at 30 and 90 days. The design compares short-term wound outcomes and patient-reported measures between the two dressing approaches.
Who should consider this trial
Good fit: Suitable candidates are adult patients undergoing open kidney transplant who are not pediatric, do not require planned reintervention within 90 days, are not allergic to NPWT components, and are not having an orthotopic transplant.
Not a fit: Patients who are pediatric, require early surgical reintervention, have allergies to NPWT materials, or have orthotopic transplants would not be expected to benefit from this protocol.
Why it matters
Potential benefit: If successful, NPWT could lower wound infections and dehiscence and speed recovery after kidney transplant.
How similar studies have performed: Prophylactic NPWT has shown benefits in lowering wound complications in several surgical fields, but data specifically in kidney transplant patients are limited.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * All patients submitted to kidney transplant Exclusion Criteria: * Pediatric patients, those requiring surgical reinterventions within the first 90 days postoperative, patients allergic to NPWT components, orthotopic transplant
Where this trial is running
Porto
- São João University Hospital — Porto, Portugal (Recruiting)
Study contacts
- Study coordinator: Alberto Silva, MD
- Email: u016845@chsj.min-saude.pt
- Phone: +351225512100
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.