NEgative prEssure Wound Therapy in Renal Transplant (NEWER)

NEgative prEssure Wound Therapy in Renal Transplant - NEWER Trial

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.

Study Overview

• Status: Recruiting
• Conditions: Renal Transplant; Wound Complication; Transplant Complication
• Intervention / Treatment: Device: NWPT group

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 Type: Interventional
• Enrollment (Estimated): 150
• Phase: Phase 4

Contacts and Locations

• Study Contact: Name: Alberto Silva, MD; Phone Number: +351225512100; Email: u016845@chsj.min-saude.pt

Study Locations

• Portugal
  • Porto, Portugal
    • Recruiting
    • São João University Hospital
    • Contact: Alberto Silva, MD; Phone Number: +351 225 512 100; Email: u016845@chsj.min-saude.pt

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: NPWT group; Patients who received negative pressure wound therapy	Device: NWPT group; Patients submitted to negative pressure wound therapy
No Intervention: Standard group; Patients who received standard dressing

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Wound dehiscence	Wound dehiscence - superficial or deep	First 90 days after surgery

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Wound infection	ASEPSIS score - (Additional treatment, Serous discharge, Erythema, Purulen exudates, Separation of deep tissues, Isolation of bacteria, Stay in hospital score); 0-10 points; higher score = worse outcome	First 90 days after surgery
Pain associated with incision	Visual analogue scale; score 0-10; higher score=worse outcome	First 90 days after surgery
Quality of life associated with incision	EQ-5D questionnaire (The 5-level quality of life version 5); score 0 -100 ; highest score=better outcome	First 90 days after surgery
Scar healing	POSAS score (The Patient and Observer Scar Assessment Scale); score 1-10; highest score=worse outcome	First 90 days after surgery

Collaborators and Investigators

• Sponsor: Centro Hospitalar De São João, E.P.E.
• Collaborators: Universidade do Porto
• Investigators: Study Director: João Alturas Silva, PhD, São João University Hospital

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2023
• Primary Completion (Estimated): May 31, 2026
• Study Completion (Estimated): June 30, 2026

Study Registration Dates

• First Submitted: June 23, 2025
• First Submitted That Met QC Criteria: July 10, 2025
• First Posted (Actual): July 15, 2025

Study Record Updates

• Last Update Posted (Actual): July 15, 2025
• Last Update Submitted That Met QC Criteria: July 10, 2025
• Last Verified: July 1, 2025

More Information

Terms related to this study

• Keywords: renal transplant; wound complication; transplant complication
• Additional Relevant MeSH Terms: Wounds and Injuries
• Other Study ID Numbers: 351-2022

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED
• IPD Plan Description: IPD will be shared upon reasonable request after consideration from local Ethics Comission

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No