Prevention of Surgical Wound Infection

Cardiac Surgery Clinical Trial

Official title:

Impact of the Use of Three Dressings in the Prevention of Surgical Wound Infection in Patients Undergoing Mayor Cardiac Surgery: a Clinical Prospective and Randomized Study

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03905213
• Other study ID #: MICRO.HGUGM.2018-008
• Status: Not yet recruiting
• Phase: N/A
• Start date: September 1, 2019
• Est. completion date: August 28, 2021

Study information

• Verified date: March 2019
• Source: Hospital General Universitario Gregorio Marañon
• Contact: Maria Jesus Perez Granda, PhD
• Phone: +34618355299
• Email: massus[@]hotmail.es
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

To compare cost effectiveness of a polyurethane dressing or a vacuum therapy dressing versus the conventional gauze in the prevention of superficial wound infection y major cardiac surgery

Description:

It is a clinical prospective and randomized study. patientes will be randomized to three groups on the day of surgery: conventional gauze, polyurethane or vacuum therapy dressing. Clinical al microbiological data will be monitorized to evaluate the infection rate of surgical wound , mediastinitis, days of hospital stay and consumption of antimicrobials.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 900
• Est. completion date: August 28, 2021
• Est. primary completion date: August 28, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• patient scheduled to cardiac surgery.

• signed informed consent form

Exclusion Criteria:

• hypersensibility to dressings

Related Conditions & MeSH terms

• Cardiac Surgery
• Surgical Wound
• Surgical Wound Infection
• Wound Infection

Intervention

Device:
• dressing MEPORE
assignation to three different authorised and on label dressing: conventional dressing (MEPORE)
• dressing MEPILEX
assignation to three different authorised and on label dressing: absorbent(MEPILEX)
• dressing PICCO
assignation to three different authorised and on label dressing:vacuum Therapy dressing(PICCO)

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Maria Jesus Perez	Instituto de Salud Carlos III

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	prevention of surgical wound infection	surgical wound infection measured as number of patients suffering surgical wound infection during the study period	surgery date up to 6 months
Secondary	hospital stay	days at hospital	from hospitalization until an average of 1 year
Secondary	antimicrobial consumption	defined dose of antimicrobial agents during hospital stay	from surgery date until an average of 1 year
Secondary	dressing consumption cost	number of dressing and its cost	from surgery date until an average of 8 weeks