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Effect of the Negative Pressure Therapy Dressing Compared With Hydrogel Dressing. (PICO/2019)

Primary Purpose

Wound Infection, Surgical

Status
Terminated
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
Pico®" negative pressure dressing
Aquacel Surgical®" hydrogel dressing
Sponsored by
Hospital Universitario de Canarias
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Wound Infection, Surgical

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Undergoing elective or emergency cardiac surgery with extracorporeal circulation heart surgery who will have a median sternotomy.
  • Who signs Informed Consent after agreeing to participate in the microbiological study.

Exclusion Criteria:

  • Patients undergoing emergency cardiac surgery that does not time to randomization and/or coding.
  • Patients with immunocompromised haematological diseases.
  • Patients who are allergic or present some hypersensitivity to the dressing or excipient.
  • Patients who are participating in another experimental study.
  • Patients who, due to their fragility or comorbidity, the surgeon considers that they should not undergo randomization.

Sites / Locations

  • Pilar Garrido Martín

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Negative Pressure dressing

Aquacel hydrogel dressing

Arm Description

Pico®" negative pressure 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.

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.

Outcomes

Primary Outcome Measures

Incidence of infection of the sternal surgical wound.
The state of the surgical wound will be assessed and recorded on the wound care data collection sheet. Note whether the wound looks good or not and whether there are any complications: exudate, appearance of the wound, necrosis of the wound edges, redness, maceration of the wound or wound dehiscence.

Secondary Outcome Measures

Full Information

First Posted
November 5, 2019
Last Updated
July 19, 2023
Sponsor
Hospital Universitario de Canarias
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1. Study Identification

Unique Protocol Identification Number
NCT04265612
Brief Title
Effect of the Negative Pressure Therapy Dressing Compared With Hydrogel Dressing.
Acronym
PICO/2019
Official Title
Effect of the Negative Pressure Therapy Dressing Compared With the Hydrogel Dressing on Surgical Wound Infection in Cardiac Surgery.
Study Type
Interventional

2. Study Status

Record Verification Date
February 2021
Overall Recruitment Status
Terminated
Why Stopped
Lack of funds preventing further payment of the trial insurance
Study Start Date
November 5, 2019 (Actual)
Primary Completion Date
July 13, 2021 (Actual)
Study Completion Date
May 18, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hospital Universitario de Canarias

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief 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".
Detailed Description
Negative pressure therapy is a type of physical therapy for wound healing that is based on the application of a negative pressure (void) in the wound bed. Negative pressure therapy is based on the application of a subatmospheric pressure in the wound bed to trigger a whole series of mechanisms, and that to a greater or lesser degree, and in a synergistic manner, act by creating or improving the conditions for the healing process to develop (negative pressure therapy). All these mechanisms act by diminishing the possibility of creating an appropriate medium for the growth of pathogenic germs. Today, negative pressure therapy is also used to create ideal conditions in surgical wounds to prevent or reduce the risk of local complications, is what we call incisional negative pressure therapy.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Wound Infection, Surgical

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Investigator
Masking Description
External evaluator: care provider
Allocation
Randomized
Enrollment
253 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Negative Pressure dressing
Arm Type
Experimental
Arm Description
Pico®" negative pressure 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.
Arm Title
Aquacel hydrogel dressing
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Procedure
Intervention Name(s)
Pico®" negative pressure dressing
Intervention Description
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
Intervention Type
Procedure
Intervention Name(s)
Aquacel Surgical®" hydrogel dressing
Intervention Description
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.
Primary Outcome Measure Information:
Title
Incidence of infection of the sternal surgical wound.
Description
The state of the surgical wound will be assessed and recorded on the wound care data collection sheet. Note whether the wound looks good or not and whether there are any complications: exudate, appearance of the wound, necrosis of the wound edges, redness, maceration of the wound or wound dehiscence.
Time Frame
1-3 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Undergoing elective or emergency cardiac surgery with extracorporeal circulation heart surgery who will have a median sternotomy. Who signs Informed Consent after agreeing to participate in the microbiological study. Exclusion Criteria: Patients undergoing emergency cardiac surgery that does not time to randomization and/or coding. Patients with immunocompromised haematological diseases. Patients who are allergic or present some hypersensitivity to the dressing or excipient. Patients who are participating in another experimental study. Patients who, due to their fragility or comorbidity, the surgeon considers that they should not undergo randomization.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Rafael Martínez Sanz, PhD
Organizational Affiliation
Hospital Universitario de Canarias
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Pilar Garrido Martín, PhD
Organizational Affiliation
Hospital Universitario de Canarias
Official's Role
Principal Investigator
Facility Information:
Facility Name
Pilar Garrido Martín
City
Santa Cruz De Tenerife
ZIP/Postal Code
38320
Country
Spain

12. IPD Sharing Statement

Learn more about this trial

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

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