Phase 4
N=293
Study of the Combination of a Cyanoacrylate and Surgical Solutions in Reducing Skin Flora Contamination
Skin Flora Contamination
Bottom Line
View on ClinicalTrials.gov: NCT00467857 ↗Enrolled (actual)
293
Serious AEs
4.8%
Results posted
Feb 2011
Primary outcome: Primary: Change in Number of Unique Bacterial Isolates From Pre-skin Preparation to Post-CABG - Sternal Site — -1.34; -1.31 isolates — p=0.655
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- InteguSeal* skin sealant and standard surgical preparation (Procedure); Standard preoperative skin preparation (Other)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Kimberly-Clark Corporation
- Primary completion
- Mar 2009
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in Number of Unique Bacterial Isolates From Pre-skin Preparation to Post-CABG - Sternal Site |
-1.34; -1.31 | 0.655 |
| PRIMARY Change in Number of Unique Bacterial Isolates From Pre-skin Preparation to Post-CABG - Graft Site |
-1.88; -1.75 | 0.359 |
| SECONDARY Change in Bacterial Count From Pre-skin Preparation to Post-CABG - Sternal Site |
-2.14; -1.99 | 0.276 |
| SECONDARY Change in Bacterial Count From Pre-skin Preparation to Post-CABG - Graft Site |
-2.42; -2.31 | 0.375 |
| SECONDARY Post-CABG Procedure Bacterial Count - Sternal Site |
0.58; 0.83 | 0.039 sig |
| SECONDARY Post-CABG Procedure Bacterial Count - Graft Site |
0.19; 0.34 | 0.057 |
| SECONDARY Change in the Number of Unique Bacterial Isolates From Pre-skin Preparation to Post-incision - Sternal Site |
-1.53; -1.59 | 0.646 |
| SECONDARY Change in the Number of Unique Bacterial Isolates From Pre-skin Preparation to Post-incision - Graft Site |
-1.95; -1.98 | 0.788 |
| SECONDARY Change in Bacterial Count From Pre-skin Preparation to Post-incision - Sternal Site |
-2.51; -2.54 | 0.960 |
| SECONDARY Change in Bacterial Count From Pre-skin Preparation to Post-incision - Graft Site |
-2.51; -2.58 | 0.730 |
| SECONDARY Post-incision Bacterial Count - Sternal Site |
0.21; 0.26 | 0.348 |
| SECONDARY Post-incision Bacterial Count - Graft Site |
0.10; 0.08 | 0.512 |
| SECONDARY Number of Patients With SSI at the Sternal Site and/or Graft Site |
9; 14 | 0.285 |
| SECONDARY Number of Patients With Alcohol Use, Tobacco Use, or Obesity With Surgical Site Infection (SSI) |
5; 11 | 0.024 sig |
Summary
The purpose of this study is to determine if there is a qualitative reduction in microbial skin flora post-surgery compared to pre-surgery when a cyanoacrylate based microbial sealant is used in combination with a surgical skin preparation solution.
Eligibility Criteria
Inclusion Criteria
- Scheduled for an elective Coronary Artery Bypass Graft (CABG) surgical procedure with median sternotomy utilizing either the saphenous vein and/or radial artery as one of the graft sites within 28 days of the screening date, as documented by a Cardiothoracic Surgeon who is the Principal Investigator or sub-investigator. This includes subjects who are also receiving internal mammary artery grafts in addition to saphenous vein and/or radial artery grafts.
- The skin near or around the proposed incision sites should be intact.
Exclusion Criteria
- Known sensitivity or allergy to cyanoacrylate, isopropyl alcohol, iodine or iodine-containing products or tape allergies.
- Female subjects that are nursing or actively lactating.
- Abnormal skin condition adjacent to or at the surgical incision sites.
- Hair removal at the surgical sites prior to entrance to the operating suite.
- Use of antimicrobial impregnated incise drapes (i.e. Ioban®).
- Hospital stay of >14 days immediately prior to scheduled CABG surgery.
- Use of chemotherapy agents, within 30 days prior to Visit 1 screening.
- Scheduled for additional chemotherapy for the duration of the study.
- Known positive Human Immunodeficiency Virus (HIV) with a CD4 count 37).
- Neutropenia (absolute neutrophil count <1000/mm3).
- Pre-operatively on an intra-aortic balloon pump or mechanical assist device.
- Has received an experimental drug or used an experimental medical device within 30 days prior to Visit 1.
- Employees of the investigator or study center with direct involvement in the proposed study or other studies under the direction of that investigator or study center.
- Any condition, which in the opinion of the investigator would exclude the subject from the study.
- Patients on steroid use for more than 1 week within 30 days of visit 1.
- Patients on immunosuppressive therapy within 30 days of visit 1.
- Depilatory creams with containing antibiotics.
Data sourced from ClinicalTrials.gov (NCT00467857). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.