NCT04265612

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

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

• Status: Terminated
• Phase: N/A
• Study type: Interventional
• Enrollment: 253 (actual)
• Sponsor: Hospital Universitario de Canarias · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Wound Infection, Surgical

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2019-11-05
• Primary completion: 2021-07-13
• Completion: 2022-05-18
• First posted: 2020-02-11
• Last updated: 2023-07-21

Locations

1 site across 1 country: Spain