Surgical Site InfectionPhase 4NCT01110772
Comparison of Iodine + Isopropyl Alcohol Versus Iodine + Antimicrobial Sealant for Skin Preparation
A Phase 4 study testing 2-octyl cyanoacrylate [InteguSEAL®] and Iodine povacrylex in isopropyl alcohol [Duraprep®, 3M] in people with Surgical Site Infection, run by National Institute of Cancerología at 1 site in Mexico.
Trial summary
The purpose if this study is to determine whether a microbial sealant (iodine + cyanoacrylate) [InteguSEAL®, Kimberly-Clark] reduces surgical site infections when compared to iodine and isopropyl alcohol (povacrylex in isopropyl alcohol) [Duraprep®] in oncologic surgery. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Surgical Site Infection
- What is being tested?
- 2-octyl cyanoacrylate [InteguSEAL®] and Iodine povacrylex in isopropyl alcohol [Duraprep®, 3M]
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,200 participants
- Where
- 1 siteMexico
- Study dates
- May 2009to Dec 2010
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients >= 18 years undergoing elective clean or clean-contaminated breast, gynecologic or digestive tract surgery
- Accepts to participate and signs the informed consent form
- Have a telephone number to be contacted after surgery
Who cannot join
- Previous allergy to one of the study products
- 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
Trial locations and contacts
1 site in 1 country.
Mexico1 site, 1 recruiting
- Recruiting
National Institute of Cancerology
Mexico City, Mexico City, 14080
Diana Vilar-Compte, MD, MsC, +52 555 628 0400 ext. 262, parakalomx@yahoo.com.mx
About this study
Official title: Comparative Study of a Iodine + Cyanoacrylate (Integuseal) vs. Iodine and Isopropyl Alcohol in Skin Preparation for Prevention of Surgical Site Infections in Oncologic Surgery
The purpose if this study is to determine whether a microbial sealant (iodine + cyanoacrylate) [InteguSEAL®, Kimberly-Clark] reduces surgical site infections when compared to iodine and isopropyl alcohol (povacrylex in isopropyl alcohol) [Duraprep®] in oncologic surgery.
Read the detailed description
Patient's skin flora is a major source of pathogens, and microbial contamination of the surgical site is a likely precursor of SSI. A variety of skin products may be used, including iodophors, alcohol-containing products, and clorhexidine gluconate. Despite these perioperative tactics, bacteria continue to survive at the skin level and migrate to contaminate the wound.
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
- Surgical Site Infection
- Being tested
- 2-octyl cyanoacrylate [InteguSEAL®], Iodine povacrylex in isopropyl alcohol [Duraprep®, 3M]
- Keywords
- Surgical site infection, Skin preparation, Cost analysis
- Medical subject headings
- Surgical Wound Infection
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
2-octyl cyanoacrylate [InteguSEAL®]Device
Also called InteguSEAL® (Kimberly Clark)
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]Device
Also called 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.
| Study group | Role | What they receive |
|---|---|---|
| 2-octyl cyanoacrylate | Experimental | 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. Receives: Device: 2-octyl cyanoacrylate [InteguSEAL®] |
| iodine povacrylex in isopropyl alcohol | Active comparator | 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. Receives: Device: Iodine povacrylex in isopropyl alcohol [Duraprep®, 3M] |
What is being measured
The primary outcome is the main question the study is designed to answer.
Surgical site infection
Patients we'll be followed prospectively by direct observation to evaluate if a surgical infection occurs. After 30 days of follow-up, patients will be classified as having or not a surgical site infection using the CDC criteria.
Measured: 30-45 days
Secondary outcomes (1)
Cost analysis
We'll be doing a cost-efectiveness analysis at the end of the study considering the treatment arm, complications developed from surgery to end of follow-up and costs for its treatment.
Measured: 30-45 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Apr 2010 (estimated)
- Study startMay 2009
- Primary completionOct 2010 (estimated)
- Study completionDec 2010 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Surgical Site InfectionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 1,200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Institute of Cancerología
- Sponsor type
- Other government
- Collaborators
- Kimberly-Clark de México
- Investigators
- Diana Vilar-Compte, MD;MsC, Principal investigator, Instituto Nacional de Cancerologia, Columbia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01110772
- Sponsor's protocol ID
- 09003INI
- Status last verified
- Apr 2010
- First submitted
- 23 Apr 2010
- Last updated
- 27 Apr 2010
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Apr 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Study of a Iodine + Cyanoacrylate (Integuseal) vs. Iodine and Isopropyl Alcohol in Skin Preparation for Prevention of Surgical Site Infections in Oncologic Surgery
- ClinicalTrials.gov ID
- NCT01110772
- Acronym / sponsor ID
- 09003INI
- Conditions
- Surgical Site Infection
- Keywords
- Surgical site infection, Skin preparation, Cost analysis
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 1,200 participants (estimated)
- Lead sponsor
- National Institute of CancerologíaOther government
- Collaborators
- Kimberly-Clark de México
- Study start
- May 2009
- Primary completion
- Oct 2010 (estimated)
- Study completion
- Dec 2010 (estimated)
- First posted
- 27 Apr 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose if this study is to determine whether a microbial sealant (iodine + cyanoacrylate) [InteguSEAL®, Kimberly-Clark] reduces surgical site infections when compared to iodine and isopropyl alcohol (povacrylex in isopropyl alcohol) [Duraprep®] in oncologic surgery.
Detailed description
Patient's skin flora is a major source of pathogens, and microbial contamination of the surgical site is a likely precursor of SSI. A variety of skin products may be used, including iodophors, alcohol-containing products, and clorhexidine gluconate. Despite these perioperative tactics, bacteria continue to survive at the skin level and migrate to contaminate the wound.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 2-octyl cyanoacrylate | Experimental | Device: 2-octyl cyanoacrylate [InteguSEAL®]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. |
| iodine povacrylex in isopropyl alcohol | Active comparator | Device: Iodine povacrylex in isopropyl alcohol [Duraprep®, 3M]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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients >= 18 years undergoing elective clean or clean-contaminated breast, gynecologic or digestive tract surgery
- Accepts to participate and signs the informed consent form
- Have a telephone number to be contacted after surgery
Key exclusion criteria (5 listed)
- Previous allergy to one of the study products
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 2-octyl cyanoacrylate [InteguSEAL®]Also: InteguSEAL® (Kimberly Clark)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). | Device | 2-octyl cyanoacrylate |
| Iodine povacrylex in isopropyl alcohol [Duraprep®, 3M]Also: 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. | Device | iodine povacrylex in isopropyl alcohol |
Primary outcome
Surgical site infection
Time frame: 30-45 days
Patients we'll be followed prospectively by direct observation to evaluate if a surgical infection occurs. After 30 days of follow-up, patients will be classified as having or not a surgical site infection using the CDC criteria.
1 secondary outcome
Cost analysis
Time frame: 30-45 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Apr 2010.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Diana Vilar-Compte, MD;MsC principal investigator
Instituto Nacional de Cancerologia, Columbia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing 2-octyl cyanoacrylate [InteguSEAL®] and Iodine povacrylex in isopropyl alcohol [Duraprep®, 3M] in people with Surgical Site Infection, run by National Institute of Cancerología at 1 site in Mexico.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 27 Apr 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Mexico. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Diana Vilar-Compte, MD, MsC (+52 555 628 0400 ext. 262, parakalomx@yahoo.com.mx), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Surgical site infection (time frame: 30-45 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Apr 2010.