NEgative prEssure Wound Therapy in Renal Transplant - NEWER Trial
Trial Snapshot
- Phase
- Phase 4
- Status
- Recruiting
- Sponsor
- Enrollment
- 150
- Locations
- 1
- Primary Endpoint
- Wound dehiscence
Study Overview
Brief 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
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Prevention
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
NPWT group
Patients who received negative pressure wound therapy
Intervention: NWPT group (Device)
Standard group
Patients who received standard dressing
Outcomes
Primary Outcomes
Wound dehiscence
Time Frame: First 90 days after surgery
Wound dehiscence - superficial or deep
Secondary Outcomes
- Pain associated with incision(First 90 days after surgery)
- Wound infection(First 90 days after surgery)
- Quality of life associated with incision(First 90 days after surgery)
- Scar healing(First 90 days after surgery)
Investigators
Alberto Costa Silva
Principal Investigator
Centro Hospitalar De São João, E.P.E.