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Effect of the Negative Pressure Therapy Dressing Compared With Hydrogel Dressing.

NCT04265612 · Status: TERMINATED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 253

Last updated 2023-07-21

No results posted yet for this study

Summary

The objective of the study is to measure the efficacy of the use of single-use portable negative pressure therapy (PICO ®) in the prevention of surgical wound infections (SSI) from cardiac surgery under extracorporeal circulation compared to single-use hydrocolloid dressings "Aquacel Surgical".

Conditions

  • Wound Infection, Surgical

Interventions

PROCEDURE

Pico®" negative pressure dressing

Pico®" negative pressure dressing that will be placed in the operating room in both sternal wound and saphenectomy.The dressing will remain on for 7 days without waking up, unless it is saturated, in which case only the dressing will be changed

PROCEDURE

Aquacel Surgical®" hydrogel dressing

Aquacel Surgical®" hydrogel dressing that will be placed in the operating room in both sternal wound and saphenectomy. This dressing will remain in place for 7 days without getting up, unless it has become saturated, in which case, only the dressing will be changed.

Sponsors & Collaborators

  • Hospital Universitario de Canarias

    lead OTHER

Principal Investigators

  • Rafael Martínez Sanz, PhD · Hospital Universitario de Canarias

  • Pilar Garrido Martín, PhD · Hospital Universitario de Canarias

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-11-05
Primary Completion
2021-07-13
Completion
2022-05-18

Countries

  • Spain

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04265612 on ClinicalTrials.gov