NCT07065734

NEgative prEssure Wound Therapy in Renal Transplant

NEgative prEssure Wound Therapy in Renal Transplant - NEWER Trial

• Status: Recruiting
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 150 (estimated)
• Sponsor: Centro Hospitalar De São João, E.P.E. · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is a prospective study involving patients undergoing open renal transplant. Renal transplant recipients were randomly divided into two groups: the NPWT group, which received NPWT, and the Standard group, which received standard wound dressings.

Detailed description

This is a prospective study involving patients undergoing open renal transplant between January 2023 and August 2024. Pediatric patients, those requiring surgical reinterventions within the first 3 postoperative months, and patients allergic to NPWT components were excluded from the study. Renal transplant recipients were randomly divided into two groups: the NPWT group, which received NPWT, and the Standard group, which received standard wound dressings. NPWT (PICO by Smith \& Nephew) was applied intraoperatively at 80 mmHg and maintained for 7 days. Wound evaluations were performed at 7, 14, 30, and 90 days post-operatively. If dehiscence was present, it was classified as either deep or superficial based on the involvement of the aponeurosis. Patients were assessed for wound infection using the ASEPSIS score, pain with a visual analogue scale, and quality of life using the EQ-5D questionnaire. Scar healing was also evaluated at 30 and 90 days post-operatively with the POSAS score

Conditions

• Transplant Complication
• Renal Transplant
• Wound Complication

Interventions

Type	Name	Description
DEVICE	NWPT group	Patients submitted to negative pressure wound therapy

Timeline

• Start date: 2023-01-01
• Primary completion: 2026-05-31
• Completion: 2026-06-30
• First posted: 2025-07-15
• Last updated: 2025-07-15

Locations

1 site across 1 country: Portugal