Trials Sponsors Conditions Drugs Pricing

Conditions

Postoperative Wound Infection

Keywords

Wound infectionSSISuture

Outcome Measures

Primary Outcomes (1)

Proportion of subjects with leg wound infection.
Primary endpoint is postoperative leg wound infection within 60 days after surgery according to the definition of Center for Disease Control.
Within 60 days after heartsurgery

Secondary Outcomes (1)

Culture-proven and antibiotic-treated wound infection after heart surgery
Within 60 days after heart surgery

Study Arms (2)

Control group

NO INTERVENTION

Ordinary sutures (Vicryl / Monocryl) is used for wound closure

Group A

ACTIVE COMPARATOR

Triclosan coated sutures (Vicryl Plus / Monocryl Plus) is used for wound closure

Device: Triclosan coated sutures

Interventions

Triclosan coated suturesDevice

Subcutaneous and cutaneous sutures coated with triclosan (Vicryl Plus / Monocryl Plus) are used to close the incisions after vein harvesting and sternotomy. All wounds are inspected before discharge from hospital and the patients are instructed to contact the study coordinator if any suspected infection occurs. In addition, all patients are controlled after thirty days by a nurse and contacted by telephone sixty days after surgery to assess postoperative infections by a predefined questionnaire. Infection symptoms are graded according to the Asepsis score and the CDC classification. Patient records including bacterial cultures and antibiotic treatment are collected for all patients with suspected infections.

Also known as: Monocryl Plus suture, Vicryl Plus suture

Group A

Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.

Eligibility Criteria

Age18 Years - 85 Years

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

Patients undergoing elective CABG at Sahlgrenska University Hospital with intended use of saphenous vein graft are included.

You may not qualify if:

Sponsors & Collaborators

Sahlgrenska University Hospital
Otherlead

Study Sites (1)

Dep of Cardiovascular Surgery and Anesthesia, Sahlgrenska Univerity Hospital

Gothenburg, 413 45, Sweden

Related Publications (2)

Steingrimsson S, Thimour-Bergstrom L, Roman-Emanuel C, Schersten H, Friberg O, Gudbjartsson T, Jeppsson A. Triclosan-coated sutures and sternal wound infections: a prospective randomized clinical trial. Eur J Clin Microbiol Infect Dis. 2015 Dec;34(12):2331-8. doi: 10.1007/s10096-015-2485-8. Epub 2015 Oct 2.
PMID: 26432552DERIVED
Thimour-Bergstrom L, Roman-Emanuel C, Schersten H, Friberg O, Gudbjartsson T, Jeppsson A. Triclosan-coated sutures reduce surgical site infection after open vein harvesting in coronary artery bypass grafting patients: a randomized controlled trial. Eur J Cardiothorac Surg. 2013 Nov;44(5):931-8. doi: 10.1093/ejcts/ezt063. Epub 2013 Feb 22.
PMID: 23435526DERIVED

MeSH Terms

Conditions

Surgical Wound InfectionWound Infection

Interventions

Sutures

Condition Hierarchy (Ancestors)

InfectionsPostoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Surgical Fixation DevicesSurgical EquipmentEquipment and Supplies

Study Officials

Anders Jeppsson, MD PhD
Sahlgrenska Univerity Hospital
PRINCIPAL INVESTIGATOR

Enrollment

392 participants (actual enrollment reported by the registry).

Study Design

Study Type: interventional
Phase: phase 4
Allocation: RANDOMIZED
Masking: QUADRUPLE
Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose: TREATMENT
Intervention Model: PARALLEL
Sponsor Type: OTHER
Responsible Party: PRINCIPAL INVESTIGATOR
PI Title: Professor, Cardiothoracic surgery

Study Record Dates

First Submitted

September 29, 2010

First Posted

September 30, 2010

Study Start

March 2009

Date type not reported

This date has not been verified as actual or estimated.

Effects of Triclosan-coated Sutures in Cardiac Surgery

Brief Summary

Registry Overview

Trial Relationships

Study Timeline

Study Start

First Submitted

First Posted

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (1)

Study Arms (2)

Control group

Group A

Interventions

Eligibility Criteria

You may qualify if:

You may not qualify if:

Sponsors & Collaborators

Study Sites (1)

Related Publications (2)

MeSH Terms

Conditions

Interventions

Condition Hierarchy (Ancestors)

Intervention Hierarchy (Ancestors)

Study Officials

Enrollment

Study Design

Study Record Dates

Source record

Locations

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

Study Start

First Submitted

First Posted

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (1)

Study Arms (2)

Control group

Group A

Interventions

Eligibility Criteria

You may qualify if:

You may not qualify if:

Sponsors & Collaborators

Study Sites (1)

Related Publications (2)

MeSH Terms

Conditions

Interventions

Condition Hierarchy (Ancestors)

Intervention Hierarchy (Ancestors)

Study Officials

Enrollment

Study Design

Study Record Dates

Source record

Locations