Health TrialsbyHealthPanel

NEgative prEssure Wound Therapy in Renal Transplant

ConditionsTransplant ComplicationRenal TransplantWound Complication
Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age18+
SponsorCentro Hospitalar De São João, E.P.E.

About this 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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

All patients submitted to kidney transplant

Disqualifiers

Pediatric patients, those requiring surgical reinterventions within the first 90 days postoperative, patients allergic to NPWT components, orthotopic transplant

Trial design

Design model

Parallel

Treatments tested in this trial

  • NWPT group

    Device

    Patients submitted to negative pressure wound therapy

Treatment groups

150 Participants
are divided into 2 treatment groups
Group A: NPWT groupActive comparator 1 intervention
Group B: Standard groupNo intervention 0 interventions

Trial outcomes

Primary outcomes

1

Wound dehiscence

Wound dehiscence - superficial or deep

Time frame
First 90 days after surgery

Secondary outcomes

1

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

Time frame
First 90 days after surgery
2

Pain associated with incision

Visual analogue scale; score 0-10; higher score=worse outcome

Time frame
First 90 days after surgery
3

Quality of life associated with incision

EQ-5D questionnaire (The 5-level quality of life version 5); score 0 -100 ; highest score=better outcome

Time frame
First 90 days after surgery
4

Scar healing

POSAS score (The Patient and Observer Scar Assessment Scale); score 1-10; highest score=worse outcome

Time frame
First 90 days after surgery

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Centro Hospitalar De São João, E.P.E.

Lead sponsor

Universidade do Porto

Collaborator

Source ClinicalTrials.gov
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