NEgative prEssure Wound Therapy in Renal Transplant - NEWER Trial
Phase: PHASE4
Conditions: Transplant Complication, Renal Transplant, Wound Complication
Sponsor: Centro Hospitalar De São João, E.P.E.

 
Official Title of the study 
Negative prEssure Wound thErapy in Renal transplant - NEWER trial  
 
 
 
NCT number - not yet assigned 
 
 
Date of the document – 10/07/2025 
 
 
 
 
 
 
 
 
 
 
 
 
 

Study Protocol: Negative prEssure Wound thErapy in Renal 
transplant - NEWER trial  
Brief Summary  
Renal transplant recipients are at increased risk for postoperative wound complications 
such as dehiscence, infection, and delayed healing, which may lead to graft failure, 
prolonged hospitalization, and increased healthcare costs. The NEWER study is a 
randomized, open-label, controlled trial evaluating the effectiveness of prophylactic 
negative pressure wound therapy (NPWT) compared to standard dressings in reducing 
wound complications after renal transplantation.  
Study Details  
Study Type: Interventional (Clinical Trial)  
Estimated Enrollment: 150 participants  
Allocation: Randomized  
Intervention Model: Parallel Assignment  
Masking: None (Open Label) Primary 
Purpose: Prevention  
Study Start Date: January 2023  
Estimated Primary Completion Date: August 2024  
Estimated Study Completion Date: November 2024  
Study Phase: Phase II-equivalent (non-drug intervention)  
Conditions Studied  
- Postoperative wound dehiscence  
- Wound infection  
- Renal transplantation  
Interventions  
Arm 1: NPWT Group  
Intervention: Application of Negative Pressure Wound Therapy  
Device: PICO™ System (Smith & Nephew)  
Procedure: Applied intraoperatively at −80 mmHg and maintained continuously for 7 
days over the closed surgical incision.  
  
Arm 2: Standard Dressing Group  
Intervention: Conventional postoperative wound care with gauze-based dressing per 
institutional protocol.  
Outcome Measures  
Primary Outcome:  
1. Incidence of Wound Dehiscence (Day 0 to Day 90)  
   - Superficial or deep dehiscence classification  
  

Secondary Outcomes:  
1. Wound Infection (ASEPSIS score) at Days 7, 14, 30, and 90  
2. Pain (Visual Analogue Scale, 0–10) at Days 7, 14, 30, and 90  
3. Scar Healing (POSAS Score) at Days 7, 14, 30, and 90  
4. Quality of Life (EQ-5D) at Pre-op Days 7, 14, 30, and 90  
5. Hospital Stay Duration  
6. Graft Function (serum creatinine, eGFR at Day 90)  
Eligibility Criteria  
Inclusion:  
- Adults (≥18 years) undergoing elective open renal transplant  
- Informed consent provided  
  
Exclusion:  
- Age <18 years  
- Allergies to NPWT components  
- Surgical reintervention within first 3 postoperative months  
- Pregnant or breastfeeding women  
- Active skin infection or dermatologic condition at surgical site  
Study Locations  
- São João University Hospital, Porto, Portugal  
Contacts  
Principal Investigator: Dr. Alberto Costa Silva, Department of Urology  
Study Coordinator Email: u016845@chsj.min-saude.pt  
Ethical Considerations  
The study has been approved by the Institutional Review Board (IRB) of São João 
University Hospital.   
Registration Statement  
This study will be registered on ClinicalTrials.gov in accordance with ICMJE and WHO 
trial registration policies.  
Statistical Analysis Plan  
All statistical analyses will be performed using SPSS. A two-sided p-value < 0.05 will be 
considered statistically significant.  
  
Descriptive statistics will be used to summarize baseline characteristics. Continuous 
variables will be presented as mean ± standard deviation or median with interquartile 
range, depending on the data distribution. Categorical variables will be expressed as 
frequencies and percentages.  
  
Primary Outcome:  

- Incidence of wound dehiscence will be compared between NPWT and Standard groups 
using the chi-square test or Fisher’s exact test.  
  
Secondary Outcomes:  
- ASEPSIS scores and pain scores (VAS) will be compared using t-tests or Mann– 
Whitney U tests, depending on normality.  
- POSAS scores and EQ-5D index values will be analyzed similarly.  
- Length of hospital stay and graft function will be analyzed using t-tests or 
nonparametric equivalents.  
  
Multivariable logistic regression may be used to adjust for potential confounding 
variables influencing wound outcomes.  
  
Missing Data:  
- Multiple imputation will be considered if missing data exceeds 5% for primary 
outcomes. Sensitivity analyses will be conducted to test robustness of findings.