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

Effect of the Negative Pressure Therapy Dressing Compared With the Hydrogel Dressing on Surgical Wound Infection in Cardiac Surgery.

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".

Study Overview

• Status: Terminated
• Conditions: Wound Infection, Surgical
• Intervention / Treatment: Procedure: Pico®" negative pressure dressing; Procedure: Aquacel Surgical®" hydrogel dressing

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: Interventional
• Enrollment (Actual): 253
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Spain
  • Santa Cruz De Tenerife, Spain, 38320
    • Pilar Garrido Martín

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	1-3 months

Collaborators and Investigators

• Sponsor: Hospital Universitario de Canarias
• Investigators: Study Director: Rafael Martínez Sanz, PhD, Hospital Universitario de Canarias; Principal Investigator: Pilar Garrido Martín, PhD, Hospital Universitario de Canarias

Study record dates

Study Major Dates

• Study Start (Actual): November 5, 2019
• Primary Completion (Actual): July 13, 2021
• Study Completion (Actual): May 18, 2022

Study Registration Dates

• First Submitted: November 5, 2019
• First Submitted That Met QC Criteria: February 10, 2020
• First Posted (Actual): February 11, 2020

Study Record Updates

• Last Update Posted (Actual): July 21, 2023
• Last Update Submitted That Met QC Criteria: July 19, 2023
• Last Verified: February 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Postoperative Complications; Infections; Surgical Wound Infection; Wound Infection; Gastrointestinal Agents; Laxatives; Carboxymethylcellulose Sodium
• Other Study ID Numbers: PICO/2019

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No