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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 12, 2021
Sponsor:
Information provided by (Responsible Party):
Hospital Universitario de Canarias

Tracking Information
First Submitted Date  ICMJE November 5, 2019
First Posted Date  ICMJE February 11, 2020
Last Update Posted Date February 12, 2021
Actual Study Start Date  ICMJE November 5, 2019
Estimated Primary Completion Date July 13, 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 10, 2020)
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.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Effect of the Negative Pressure Therapy Dressing Compared With Hydrogel Dressing.
Official Title  ICMJE Effect of the Negative Pressure Therapy Dressing Compared With the Hydrogel Dressing on Surgical Wound Infection in Cardiac Surgery.
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Investigator)
Masking Description:
External evaluator: care provider
Primary Purpose: Prevention
Condition  ICMJE Wound Infection, Surgical
Intervention  ICMJE
  • 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.
Study Arms  ICMJE
  • 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.
    Intervention: Procedure: Pico®" negative pressure dressing
  • 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.
    Intervention: Procedure: Aquacel Surgical®" hydrogel dressing
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: February 10, 2020)
304
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE July 13, 2021
Estimated Primary Completion Date July 13, 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Pilar Garrido Martín, PhD +34 9226786293 doctoragarrido@gmail.com
Contact: Patricia Rodríguez Fortúnez, PhD +34 9226788117 patricia.rodriguez@scren.es
Listed Location Countries  ICMJE Spain
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04265612
Other Study ID Numbers  ICMJE PICO/2019
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Current Responsible Party Hospital Universitario de Canarias
Original Responsible Party Same as current
Current Study Sponsor  ICMJE Hospital Universitario de Canarias
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Rafael Martínez Sanz, PhD Hospital Universitario de Canarias
Principal Investigator: Pilar Garrido Martín, PhD Hospital Universitario de Canarias
PRS Account Hospital Universitario de Canarias
Verification Date February 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP