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

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ClinicalTrials.gov Identifier: NCT04265612
Recruitment Status : Recruiting
First Posted : February 11, 2020
Last Update Posted : February 11, 2020
Sponsor:
Information provided by (Responsible Party):
Hospital Universitario de Canarias

Study Description
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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".

Condition or disease Intervention/treatment Phase
Wound Infection, Surgical Procedure: Pico®" negative pressure dressing Procedure: Aquacel Surgical®" hydrogel dressing Not Applicable

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.

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 304 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Investigator)
Masking Description: External evaluator: care provider
Primary Purpose: Prevention
Official Title: Effect of the Negative Pressure Therapy Dressing Compared With the Hydrogel Dressing on Surgical Wound Infection in Cardiac Surgery.
Actual Study Start Date : November 5, 2019
Estimated Primary Completion Date : July 13, 2021
Estimated Study Completion Date : July 13, 2021

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Arms and Interventions
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Arm Intervention/treatment
Experimental: Negative Pressure dressing
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.
 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
Active Comparator: Aquacel 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.
 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.


Outcome Measures
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Primary Outcome Measures :
  1. Incidence of infection of the sternal surgical wound. [ Time Frame: 1-3 months ]
    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.


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04265612


Contacts
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Contact: Pilar Garrido Martín, PhD +34 9226786293 doctoragarrido@gmail.com
Contact: Patricia Rodríguez Fortúnez, PhD +34 9226788117 patricia.rodriguez@scren.es

Locations
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Spain
Pilar Garrido Martín Recruiting
Santa Cruz De Tenerife, Spain, 38320
Contact: Pilar Garrido Martin, PhD, MD    +34 922678293    doctoragarrido@gmail.com   
Contact: Patricia Rodríguez Fortúnez, PhD    +34 922678117    patricia.rodriguez@scren.es   
Sponsors and Collaborators
Hospital Universitario de Canarias
Investigators
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Study Director: Rafael Martínez Sanz, PhD Hospital Universitario de Canarias
Principal Investigator: Pilar Garrido Martín, PhD Hospital Universitario de Canarias
More Information
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Responsible Party: Hospital Universitario de Canarias
ClinicalTrials.gov Identifier: NCT04265612    
Other Study ID Numbers: PICO/2019
First Posted: February 11, 2020    Key Record Dates
Last Update Posted: February 11, 2020
Last Verified: February 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Infection
Wound Infection
Surgical Wound Infection
Postoperative Complications
 Pathologic Processes
Carboxymethylcellulose Sodium
Laxatives
Gastrointestinal Agents