NEgative prEssure Wound Therapy in Renal Transplant | NCT07065734

Studies
NEgative prEssure Wound Therapy in Renal Transplant

NCT07065734

Sponsor

Centro Hospitalar De São João, E.P.E.

Status

Recruiting

Last Update Posted

Jul 15, 2025Actual

Enrollment

150Estimated

Phase

Phase 4

Conditions

Transplant Complication
Renal Transplant
Wound Complication

Interventions

NWPT group

Countries

Portugal

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

Large Document Module

Document Has No Statistical Analysis Plan (SAP)

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jul 2025

Overall Recruitment Status or Expanded Access Status

Recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 1, 2023Actual

Primary Completion Date

May 31, 2026Estimated

Completion Date

Jun 30, 2026Estimated

First Submitted Date

Jun 23, 2025

First Submission Date that Met QC Criteria

Jul 10, 2025

First Posted Date

Jul 15, 2025Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jul 10, 2025

Last Update Posted Date

Jul 15, 2025Actual

Name	Class
Universidade do Porto	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 4

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

150Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
NPWT group	Active Comparator	Patients who received negative pressure wound therapy	Device: NWPT group
Standard group	No Intervention	Patients who received standard dressing

Interventions

Name	Type	Description	Arm Group Labels	Other Names
NWPT group	Device	Patients submitted to negative pressure wound therapy	NPWT group

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

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

Other Outcomes

Not provided

Eligibility Module

Eligibility 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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Alberto Silva, MD	Contact	+351225512100		u016845@chsj.min-saude.pt

Overall Officials

Name	Affiliation	Role
João Alturas Silva, PhD	São João University Hospital	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
São João University Hospital	Recruiting	Porto			Portugal

IPD Sharing Statement Module

Plan to Share IPD

Undecided

Description

IPD will be shared upon reasonable request after consideration from local Ethics Comission

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided