Local Collagen-Gentamicin and Extra Fixation of the Sternum for Prevention of Sternal Wound Infection in Cardiac Surgery

NCT00484055 | Completed

• 1 other identifier: OFR02
• Study Type: interventional
• Target: 1,358
• Locations: 1 country
• Sites: 2

Brief Summary

The aim of the present study is to evaluate a new technique for prevention of sternal wound infection consisting of local application of collagen-gentamicin in addition to routine i.v. antibiotic prophylaxis. The technique has been evaluated in a previous randomised study. The aim of the present study is to evaluate the technique after it has been introduced in clinical practise to monitor the bacterial antibiotic susceptibility and to verify that the suggested reduction in sternal wound infection still exits.

Conditions

Drug Resistance, Bacterial; Postoperative Wound Infection

Keywords

Antibiotic Prophylaxis

Outcome Measures

Primary Outcomes (1)

• The incidences of methicillin- and gentamicin resistant microbiological agents in sternal wound infections that develop in study patients

  Within 2 months postoperatively

Secondary Outcomes (2)

• The absolute incidence of all SWI and of superficial SWI within 2 months and the relative (the ratio) incidences of superficial vs deep SW

  2 months postoperatively

• The total incidence of SWI that requires surgical revision of the wound

  2 months postoperatively

Study Arms (1)

treatment

ACTIVE COMPARATOR

Use of local CollagenGentamicin and enhanced sternal fixation according to the Clinical routine introduced 4 years earlier as a result of a previous RCT on 2000 patients. In that sense these patients did not receive any intervention but just the standard treatment introduced 4 years earlier. The aim of the study was to PROSPECTIVELY include a defined number of patients to compare their complication rate with that from aControl Group of patients från a previous RCT to verify that the effect of the treatment was stable over time. As the study did not include any intervention compared to the present standard treatment at that time ethical approval was Exempt.

Drug: Local application of collagen-gentamicin; Procedure: Fixation of the sternotomy with more than six wires

Interventions

Local application of collagen-gentamicin DRUG

Application of 2 sponges (5 x 20 cm) of collagen-gentamicin between the sternal halves immediately before sternal closure

Also known as: Collatamp-G

treatment

Fixation of the sternotomy with more than six wires PROCEDURE

At least 7 (or more) sternal fixation wires (preferaby put as separate single wires) used for fixation of the sternum at wound closure

treatment

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• All consecutive cardiac surgery patients operated via median sternotomy

You may not qualify if:

• Known allergy or other contraindication to gentamicin or bovine collagen.
• Pregnancy or breast feeding
• Treatment with aminoglycosides during the last week

Sponsors & Collaborators

• Region Örebro County: lead
• University Hospital, Linkoeping: collaborator

Study Sites (2)

University Hospital, Dept of Cardiothoracic Surgery

Linköping, 58185, Sweden

Location

Dept of Cardiothoracic Surgery, University Hospital

Örebro, 70185, Sweden

Location

Related Publications (4)

• Friberg O, Svedjeholm R, Kallman J, Soderquist B. Incidence, microbiological findings, and clinical presentation of sternal wound infections after cardiac surgery with and without local gentamicin prophylaxis. Eur J Clin Microbiol Infect Dis. 2007 Feb;26(2):91-7. doi: 10.1007/s10096-006-0252-6.

  PMID: 17211605 BACKGROUND

• Friberg O, Dahlin LG, Soderquist B, Kallman J, Svedjeholm R. Influence of more than six sternal fixation wires on the incidence of deep sternal wound infection. Thorac Cardiovasc Surg. 2006 Oct;54(7):468-73. doi: 10.1055/s-2006-924437.

  PMID: 17089314 BACKGROUND

• Friberg O, Svedjeholm R, Soderquist B, Granfeldt H, Vikerfors T, Kallman J. Local gentamicin reduces sternal wound infections after cardiac surgery: a randomized controlled trial. Ann Thorac Surg. 2005 Jan;79(1):153-61; discussion 161-2. doi: 10.1016/j.athoracsur.2004.06.043.

  PMID: 15620935 BACKGROUND

• Friberg O, Dahlin LG, Kallman J, Kihlstrom E, Soderquist B, Svedjeholm R. Collagen-gentamicin implant for prevention of sternal wound infection; long-term follow-up of effectiveness. Interact Cardiovasc Thorac Surg. 2009 Sep;9(3):454-8. doi: 10.1510/icvts.2009.207514. Epub 2009 Jun 18.

  PMID: 19541691 DERIVED

MeSH Terms

Conditions

Surgical Wound Infection

Condition Hierarchy (Ancestors)

Wound Infection; Infections; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Örjan Friberg, MD, PhD

  Dept of Cardiothoracic Surgery and Anestesiology, University Hospital Orebro, Sweden

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, PhD

Study Record Dates

• First Submitted: June 6, 2007
• First Posted: June 8, 2007
• Study Start: January 1, 2007
• Primary Completion: August 1, 2008
• Study Completion: August 1, 2008
• Last Updated: October 13, 2016

Record last verified: 2016-10

Locations

SE (2)