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

Wound Infection, Surgical Clinical Trial

— PICO/2019  

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT04265612
• Other study ID #: PICO/2019
• Status: Terminated
• Phase: N/A
• Start date: November 5, 2019
• Est. completion date: May 18, 2022

Study information

• Verified date: February 2021
• Source: Hospital Universitario de Canarias
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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".

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 253
• Est. completion date: May 18, 2022
• Est. primary completion date: July 13, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Infections
• Surgical Wound Infection
• Wound Infection
• Wound Infection, Surgical

Intervention

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
• 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.

Locations

Country	Name	City	State
Spain	Pilar Garrido Martín	Santa Cruz De Tenerife

Sponsors (1)

Lead Sponsor	Collaborator
Hospital Universitario de Canarias

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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