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Impact of Vicryl Plus to prevent infection of leg in the operations of Safena Bypasses.

Effect of using Triclosan-impregnated Polyglactin suture to prevent infection of saphenectomy wounds in Coronary Artery Bypass Grafting surgery: a prospective, double-blind, randomized clinical trial

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
REBEC
Registry ID
RBR-4gfk87
Enrollment
Unknown
Registered
2019-01-07
Start date
2011-02-22
Completion date
Unknown
Last updated
2025-10-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Patients submitted exclusively to Myocardial Revascularization with or without Extracorporeal Circulation

Interventions

Experimental - Polyglactin suture coated with polyglactin 370 and calcium stearate impregnated with Triclosan (Irgacare MP *), which is (5-chloro-2 (2,4-dichlorophenoxyphenol)). This procedure was app
Procedure/surgery
A07.231.908.819

Sponsors

Instituto Nacional de Cardiologia
Lead Sponsor
Johnson
Collaborator

Eligibility

Age
30 Years to No maximum

Inclusion criteria

Inclusion criteria: Volunteers with indication of myocardial revascularization, with or without extracorporeal circulation; of both sexes, with age above 30 years

Exclusion criteria

Exclusion criteria: Emergency surgeries; other cardiovascular surgery; antibiotic therapy for prior infectious disease, up to one month prior; immunosuppressed patient, defined in this study as a patient with AIDS, neoplasia or use of corticoid; patients requiring carotid artery surgery; bi-laterally saponectomized; severe peripheral vascular disease; venous disease of the deep system of infertile limbs; superficial saphenous vein thrombophlebitis; psychiatric disorder

Design outcomes

Primary

MeasureTime frame
The safenectomy wound infection rate, it is a binary variable (presence or absence) that will be measured by percentage of occurrence

Secondary

MeasureTime frame
Rate of pain in the wounds of the saphenectomy; evaluated in three visits in the first thirty days after surgery; criterion; 0 = absence, 1 = mild, 2 = moderate, 3 = severe.;Rate of hyperthermia in saphenectomy wounds evaluated at three visits in the first 30 days after surgery; criterion, with touch with glove of; cold, normal and hot.

Countries

Brazil

Contacts

Public ContactPaulo Samuel Santos-Filho

Instituto Nacional de Cardiologia

paulosamuelsantosf@gmail.com55 21 981160246

Outcome results

None listed

Source: REBEC (via WHO ICTRP)