Comparing TCHG Dressing With Conventional Dressing for Evaluation of Antimicrobial Efficacy on DVC Insertion Site
Study Details
Study Description
Brief Summary
It's to investigate the difference of the number of microorganisms at the DVC insertion site and catheter tip after catheter removal both in Tegaderm CHG dressing group and Tegaderm standard dressing group. The objective of this study is to evaluate the antimicrobial efficacy and safety observation in skin condition of Tegaderm CHG dressing on DVC insertion site in adult patients in critical care comparing with Tegaderm Standard Dressing.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
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N/A |
Detailed Description
Central venous catheters (CVC) inserted and PICCO and hemodialysis catheters are widely used in patients for treatment and hemodynamic monitoring in China and worldwide. Catheter-Related Blood Stream Infections (CRBSI) pose a serious risk for already compromised patient population, where it is estimated that 3-5% of catheter-related procedures will result in CRBSI1 (Moureau et al, 2009). In order to continue to reduce CRBSI, the use of chlorhexidine impregnated dressings is recommended by WHO, NICE and the CDC. Clinical efficacy, demonstrated by a reduction in catheter related bloodstream infections and/or central line associated bloodstream infections has been demonstrated in multiple clinical trials2,3,4. Multiple studies have demonstrated that Tegaderm CHG dressing is intuitive to use and carries no greater risk of adverse skin reactions that existing comparable products5-9. The NICE guidance committee concluded that the Tegaderm CHG Dressing demonstrated cost-effective benefits while offering significantly improved CRBSI protection, as compared to non-chlorhexidine dressings.
The patient's own skin flora is the most dangerous source of infecting agent. CVCs may become colonized via migration of microorganisms from the CVC insertion site down the external catheter surface, during manipulation of catheter hubs, hematogenous seeding from another site of infection, or contaminated infusates10,11. CHG impregnated securement dressing maintains low skin organism count while dressing is in place. While CHG has been long used as a skin disinfectant and antiseptic, challenges arise as the skin's microflora begins to regrow mere hours post disinfection. A study12 demonstrated that Tegaderm CHG dressing significantly reduced the number of microorganisms at the CVC insertion and suture sites with concomitant reduced catheter colonization.
Although many studies demonstrated clinical efficacy in reduction of skin colonization and catheter colonization, as far as we know, few studies have been reported on the clinical performance of Tegaderm CHG dressing application in China. A China study reported that the incidence of ICU-acquired carbapenem-resistant Klebsiella pneumoniae (CRKP) catheter related colonization/infection was 10.08 per 1000 ICU patient-days13. China KOLs insist on a local study to demonstrate the clinical benefit of Tegaderm CHG dressing in China due to the local-based clinical practice and treatment environments. Only with the substantiation of local evidence for Tegaderm CHG dressing in China, they would like to recommend it to be used in routine ward/nurse care.
Moreover, there is a significant demand to have a solid local evidence to prove the cost effectiveness of Tegaderm CHG dressing, which results to improving local care for critical illness.
So, this outside hospital study is proposed to develop local evidences for Tegaderm CHG dressing on bacteria colonization as 1st step to demonstrate the clinical value in China. This study will help to develop and maintain KOL and ICUs relationship as well. And the generated evidence in China may help for requirement of certificate renewal.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Tegaderm CHG Dressing Tegaderm CHG dressing is used to cover and protect insertion catheter sites and to secure devices to skin. It is available in a variety of shapes and sizes. Tegaderm CHG Dressing is intended to reduce skin colonization and catheter colonization and to suppress regrowth of microorganisms commonly related to bloodstream infections. Tegaderm CHG dressing is intended to reduce catheter-related bloodstream infections (CRBSI) in patients with central venous or arterial catheters. |
Device: Tegaderm CHG Dressing
Tegaderm CHG dressing consists of a transparent adhesive dressing and an integrated gel pad containing 2% w/w chlorhexidine gluconate (CHG), a well-known antiseptic agent with broad spectrum antimicrobial and antifungal activity. The gel pad absorbs fluid. The transparent film provides an effective barrier against external contamination including fluids (waterproof), bacteria, viruses* and yeast, and protects the I.V. site. In vitro testing (time kill and zone of inhibition) demonstrates that the Tegaderm™ CHG gel pad in the dressing has an antimicrobial effect against a variety of gram-positive and gram-negative bacteria, and yeast. Tegaderm CHG dressing is transparent, allowing continual site observation, and is breathable, allowing good moisture vapor exchange.
|
| Active Comparator: Tegaderm Standard Dressing Tegaderm Standard Dressing is used to cover and protect insertion catheter sites and to secure devices to skin. |
Device: Tegaderm CHG Dressing
Tegaderm CHG dressing consists of a transparent adhesive dressing and an integrated gel pad containing 2% w/w chlorhexidine gluconate (CHG), a well-known antiseptic agent with broad spectrum antimicrobial and antifungal activity. The gel pad absorbs fluid. The transparent film provides an effective barrier against external contamination including fluids (waterproof), bacteria, viruses* and yeast, and protects the I.V. site. In vitro testing (time kill and zone of inhibition) demonstrates that the Tegaderm™ CHG gel pad in the dressing has an antimicrobial effect against a variety of gram-positive and gram-negative bacteria, and yeast. Tegaderm CHG dressing is transparent, allowing continual site observation, and is breathable, allowing good moisture vapor exchange.
|
Outcome Measures
Primary Outcome Measures
- Rate of CVC tip colonization (positive catheters after culture/total catheters) [immediately after therapy]
Rate of CVC tip colonization (positive catheters after culture/total catheters)
Secondary Outcome Measures
- Number of Positive cultured CVC tip cases per 1000 catheters days [immediately after therapy]
number of Positive cultured CVC tip cases per 1000 catheters days
- Rate of PICCO tip and insertion site colonization (cultured positive case/total catheters, cultured positive case per 1000 catheter days) [immediately after therapy]
Rate of PICCO tip and insertion site colonization (cultured positive case/total catheters, cultured positive case per 1000 catheter days)
- Rate of hemodialysis catheters tip and insertion site colonization (cultured positive case/total catheters, cultured positive case per 1000 catheter days) [immediately after therapy]
Rate of hemodialysis catheters tip and insertion site colonization (cultured positive case/total catheters, cultured positive case per 1000 catheter days)
- CLBSI/CLABSI incidence rate [immediately after the procedure]
CLBSI/CLABSI incidence rate
- Microorganisms type (G+/G-/ candida) [immediately after therapy]
Microorganisms type (G+/G-/ candida)
- Wear time and change frequency of dressing due to detachment [immediately after therapy]
Wear time and change frequency of dressing due to detachment
Eligibility Criteria
Criteria
Inclusion Criteria:
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Eighteen (18) years of age or older
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Anticipated to require Central Venous Catheters (CVC) with/without PICCO catheters or dialysis catheters
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Has a catheter insertion site free of deformities, phlebitis, infiltration, dermatitis, burns, or lesions
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Demonstrates cooperation with the DVC insertion and the securement and caring per protocol
Exclusion Criteria:
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Catheters inserted suspicious of infection judged by investigator based upon insertion setting, catheters carrying day and insertion location.
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Has a documented or known allergy (sensitivity) to products with adhesives, e.g. transparent film adhesive dressings and CHG
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A current or past participant in this study
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Requires the application of a topical ointment or solution under the Tegaderm CHG dressing or Tegaderm standard dressing in addition to the prep required in the protocol
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Patients with exiting BSI.
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Pregnant or breastfeeding women.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Ruijin Hospital | Shanghai | Shanghai | China |
Sponsors and Collaborators
- 3M
Investigators
- Principal Investigator: Hongping Qu, Ruijin Hospital
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- EM-05-014894