Comparison of Iodine + Isopropyl Alcohol Versus Iodine + Antimicrobial Sealant for Skin Preparation
NCT ID: NCT01110772
Last Updated: 2010-04-27
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
UNKNOWN
PHASE4
1200 participants
INTERVENTIONAL
2009-05-31
2010-12-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Study of the Combination of a Cyanoacrylate and Surgical Solutions in Reducing Skin Flora Contamination
NCT00467857
Iodine Impregnated Incision Drapes and Bacterial Recolonization in Simulated Knee Surgery. A Controlled Randomized Experimental Trial.
NCT02342561
The Use of Diluted Povidone Iodine Irrigation in Spine Surgery
NCT01577524
Use of an Oxidized Regenerated Cellulose After Thyroid Surgery: A Prospective, Randomized Study
NCT01171079
Recolonization Following Preoperative Disinfection Plastic Adhesive Drapes
NCT01316588
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
A microbial sealant (InteguSEAL®, Kimberly-Clark) that uses cyanoacrylate to seal endogenous skin flora has demonstrated to reduce wound contamination. The efficacy of the microbial sealant in preventing SSI has been tested in cardiovascular surgery and open inguinal hernia repair, with a reduction on SSI rate when compared to standard skin preparations. This cyanoacrylate has not been tested in oncologic surgeries.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
PREVENTION
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
2-octyl cyanoacrylate
As recommended, povidone iodine is used for skin antisepsis. After drying, a layer of cyanoacrylate is applied on the skin surface with the purpose of immobilizing skin bacteria.
2-octyl cyanoacrylate [InteguSEAL®]
At operating room arrival prior to surgery, povidone-iodine is applied on the skin surface on concentric circles as recommended; after drying, the cyanoacrylate device is opened and a layer of the sealant is applied on the incision and skin site(IS100 for patients undergoing mastectomy, and IS200 for patients undergoing gynecologic or digestive tract surgeries).
iodine povacrylex in isopropyl alcohol
Iodine povacrylex in isopropyl alcohol (Duraprep 3M) This is considered a standard of care in our hospital as many other institutions. It's efficacy and safety have been demonstrated.
Iodine povacrylex in isopropyl alcohol [Duraprep®, 3M]
At the operating room arrival a few minutes before the incision, cleansing and skin antisepsis is done with the prefilled device with iodine povacrylex in isopropyl alcohol as recommended by 3M.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
2-octyl cyanoacrylate [InteguSEAL®]
At operating room arrival prior to surgery, povidone-iodine is applied on the skin surface on concentric circles as recommended; after drying, the cyanoacrylate device is opened and a layer of the sealant is applied on the incision and skin site(IS100 for patients undergoing mastectomy, and IS200 for patients undergoing gynecologic or digestive tract surgeries).
Iodine povacrylex in isopropyl alcohol [Duraprep®, 3M]
At the operating room arrival a few minutes before the incision, cleansing and skin antisepsis is done with the prefilled device with iodine povacrylex in isopropyl alcohol as recommended by 3M.
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* Accepts to participate and signs the informed consent form
* Have a telephone number to be contacted after surgery
Exclusion Criteria
* Two or more procedures in different anatomical sites at the same time / surgery (v.g. hysterectomy and mastectomy)
* Pregnancy
* Breast feeding
* Contaminated or infected surgeries
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Kimberly-Clark de México
UNKNOWN
National Institute of Cancerología
OTHER_GOV
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Departmentof Infectious Diseases. Instituto Nacional de Cancerología
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Diana Vilar-Compte, MD;MsC
Role: PRINCIPAL_INVESTIGATOR
Instituto Nacional de Cancerologia, Columbia
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
National Institute of Cancerology
Mexico City, Mexico City, Mexico
Countries
Review the countries where the study has at least one active or historical site.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Facility Contacts
Find local site contact details for specific facilities participating in the trial.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
09003INI
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.