Ignite Creation Date:
2024-05-05 @ 5:33 PM
Last Modification Date:
2024-10-26 @ 9:33 AM
Study NCT ID:
NCT00484055
Status:
COMPLETED
Last Update Posted:
2016-10-13
First Post:
2007-06-06
Brief Title:
Local Collagen-Gentamicin and Extra Fixation of the Sternum for Prevention of Sternal Wound Infection in Cardiac Surgery
Sponsor:
Region Örebro County
Organization:
Region Örebro County
Study Overview
Official Title:
Local Application of Collagen-Gentamicin in Addition to Fixation of the Sternum With Extra Sternal Wires for Prevention of Sternal Wound Infection in Cardiac Surgery
Status:
COMPLETED
Status Verified Date:
2016-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
LOGIX
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 iv 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
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
Detailed Description:
A new technique for prevention of sternal wound infections after cardiac surgery is studied Local application directly in the surgical wound of aminoglycoside antibiotics gentamicin bound to collagen reduced the incidence of wound infection with more than 50 in a previous prospective randomised trial
As the technique has been introduced in clinical practise two questions need to be monitored
Are there signs of change in the bacteria that cause the wound infections with a shift over time towards more gentamicin resistant agents
Is the effect of the prophylaxis still comparable to that which was seen in the previous study
Furthermore results from the previous study indicated that the effect of the local antibiotic was better when combined with an extra rigid sternal wound infection defined as at least one extra steel wire for sternal fixation
The study is conducted at those two Swedish cardiothoracic surgery centers where it was first studied There are thus two objectives of the study first to analyze the microbiologic findings of the sternal wound infections that occur and secondly to monitor the incidence of sternal wound infection especially deep infections when the local collagen-gentamicin prophylaxis is used in daily routine in combination with a specific surgical technique for optimization of the strength of sternal fixation
As the technique has been introduced in clinical practise two questions need to be monitored
Are there signs of change in the bacteria that cause the wound infections with a shift over time towards more gentamicin resistant agents
Is the effect of the prophylaxis still comparable to that which was seen in the previous study
Furthermore results from the previous study indicated that the effect of the local antibiotic was better when combined with an extra rigid sternal wound infection defined as at least one extra steel wire for sternal fixation
The study is conducted at those two Swedish cardiothoracic surgery centers where it was first studied There are thus two objectives of the study first to analyze the microbiologic findings of the sternal wound infections that occur and secondly to monitor the incidence of sternal wound infection especially deep infections when the local collagen-gentamicin prophylaxis is used in daily routine in combination with a specific surgical technique for optimization of the strength of sternal fixation
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None