Surgical Site InfectionPhase 4IntegusealNCT02241915
Use of a Microbial Sealant to Reduce Surgical Site Infections.
A Phase 4 study testing Open Colorectal Surgery and Laparoscopic Surgery in people with Surgical Site Infection and SCIP, run by University of Southern California at 1 site in United States.
Trial summary
Surgical site infections (SSI) are costly complications that may cause significant morbidity and increase the cost of care, particularly in colorectal surgery. Microbial sealants (MS) are a new class of wound barriers aimed at decreasing SSI, however there is only evidence of benefit in clean Class 1 procedures. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Surgical Site Infection, SCIP
- What is being tested?
- Open Colorectal Surgery and Laparoscopic Surgery
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 100 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2011to May 2012
- 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Nonemergent colon and/or rectal abdominal surgical procedures
- Women of child-bearing potential must have a negative serum HCG assay prior to surgery
- Ages ≥18 years.
Who cannot join
- Known history of hypersensitivity to cyanoacrylate, formaldehyde or acetone products.
- Undergoing emergency surgery (urgent surgery is allowed if informed consent is obtained and the study procedures can be performed). Emergency surgery includes cases where standard bowel preparation and other preoperative assessments cannot be done.
- Undergoing a significant concomitant surgical procedure (e.g., Whipple \& organ transplant surgery).
- The following concomitant procedures are allowed: appendectomy, cholecystectomy, oophorectomy, liver biopsy/wedge resection (but not liver resection), cystectomy.
- History of prior laparotomy within the last 60 days of this planned procedure.
- Planned to undergo a second laparotomy or colorectal surgical procedure (e.g. colostomy or ileostomy takedown) within 60 days of this planned first procedure.
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- Evidence preoperatively of any of the following: sepsis, severe sepsis, or septic shock (note that SIRS alone is not an exclusion criteria).6, 7
- Preoperative severe neutropenia defined as total neutrophil count ≤500 × 106/L.
- Current abdominal wall infection/surgical site infection from previous laparotomy/laparoscopy or for any reason.
- Receiving antibiotic therapy within the 1 week prior to the date of surgery.
- Preoperative evaluation suggests intra-abdominal process that might preclude full closure of the skin.
- Preoperative serum creatinine > 3 mg/dL or renal failure requiring dialysis.
- History of ongoing treatment (e.g. chemotherapy, radiation) for non-colorectal cancer.
- History of major organ transplantation, including bone marrow transplantation.
- Taking systemic steroids >10 mg prednisone daily or remicade within 2 weeks prior to surgery or a history of a current immunosuppressive condition (eg, symptomatic HIV infection), defined as a CD4 count < 200.
- Pregnant, lactating, or of childbearing potential not practicing a birth control method with a high degree of reliability (defined in section 3.1).
- Participation within 30 days before the start of this study in any experimental drug or device study, or currently participating in a study in which the administration of investigational drug or device within 60 days is anticipated.
Trial locations and contacts
1 site in 1 country.
United States1 site
Los Angeles County/USC Medical Center
Los Angeles, California, 90033
About this study
Official title: Microbial Sealants Do Not Decrease Surgical Site Infection for Clean Contaminated Colorectal Procedures.
Surgical site infections (SSI) are costly complications that may cause significant morbidity and increase the cost of care, particularly in colorectal surgery. Microbial sealants (MS) are a new class of wound barriers aimed at decreasing SSI, however there is only evidence of benefit in clean Class 1 procedures. Based on its success in Class 1 procedures, we hypothesized that a microbial sealant could reduce the rate of SSI by half for clean contaminated colorectal procedures (Class 2).
- Conditions
- Surgical Site Infection, SCIP
- Being tested
- Open Colorectal Surgery, Laparoscopic Surgery
- 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.
Open Colorectal SurgeryProcedure or surgery
Laparoscopic SurgeryProcedure or surgery
| Study group | Role | What they receive |
|---|---|---|
| Microbial Sealant | Active comparator | Integuseal (Kimberly Clark) Receives: Procedure: Open Colorectal Surgery; Procedure: Laparoscopic Surgery |
| Control | Sham comparator | No microbial sealant Receives: Procedure: Open Colorectal Surgery; Procedure: Laparoscopic Surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of SSI with and without microbial sealant.
Determine the rate of SSI when microbial sealant (InteguSEAL© Kimberly-Clark) is used compared to control (no microbial sealant).
Measured: 15 Months
Secondary outcomes (1)
Subgroup incidence of SSI with and without microbial sealant
Compare SSI for open vs. laparoscopy colectomy, age, BMI, diabetes and morbidity (ASA class), hospital readmission, reoperation and wound dehiscence with and without microbial sealant.
Measured: 15 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Sep 2014 (estimated)
- Study startJan 2011
- Primary completionMay 2012
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.
- More trials run by University of Southern CaliforniaThe sponsor's other registered studies.
- 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
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Southern California
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Michael Doorly, University of Southern California
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02241915
- Sponsor's protocol ID
- HS-10-00471
- Acronym
- Integuseal
- Status last verified
- Sep 2014
- First submitted
- 13 Sep 2014
- Last updated
- 16 Sep 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Sep 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Microbial Sealants Do Not Decrease Surgical Site Infection for Clean Contaminated Colorectal Procedures.
- ClinicalTrials.gov ID
- NCT02241915
- Acronym / sponsor ID
- Integuseal / HS-10-00471
- Conditions
- Surgical Site Infection, SCIP
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- University of Southern CaliforniaUniversity, hospital or other
- Study start
- Jan 2011
- Primary completion
- May 2012 (actual)
- First posted
- 16 Sep 2014 (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.
Surgical site infections (SSI) are costly complications that may cause significant morbidity and increase the cost of care, particularly in colorectal surgery. Microbial sealants (MS) are a new class of wound barriers aimed at decreasing SSI, however there is only evidence of benefit in clean Class 1 procedures. Based on its success in Class 1 procedures, we hypothesized that a microbial sealant could reduce the rate of SSI by half for clean contaminated colorectal procedures (Class 2).
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Microbial Sealant | Active comparator | Procedure: Open Colorectal Surgery, Procedure: Laparoscopic SurgeryInteguseal (Kimberly Clark) |
| Control | Sham comparator | Procedure: Open Colorectal Surgery, Procedure: Laparoscopic SurgeryNo microbial sealant |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Nonemergent colon and/or rectal abdominal surgical procedures
- Women of child-bearing potential must have a negative serum HCG assay prior to surgery
- Ages ≥18 years.
Key exclusion criteria (17 listed)
- Known history of hypersensitivity to cyanoacrylate, formaldehyde or acetone products.
- Undergoing emergency surgery (urgent surgery is allowed if informed consent is obtained and the study procedures can be performed). Emergency surgery includes cases where standard bowel preparation and other preoperative assessments cannot be done.
- Undergoing a significant concomitant surgical procedure (e.g., Whipple \& organ transplant surgery).
- The following concomitant procedures are allowed: appendectomy, cholecystectomy, oophorectomy, liver biopsy/wedge resection (but not liver resection), cystectomy.
- History of prior laparotomy within the last 60 days of this planned procedure.
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 |
|---|---|---|
| Open Colorectal Surgery | Procedure or surgery | Control, Microbial Sealant |
| Laparoscopic Surgery | Procedure or surgery | Control, Microbial Sealant |
Primary outcome
Incidence of SSI with and without microbial sealant.
Time frame: 15 Months
Determine the rate of SSI when microbial sealant (InteguSEAL© Kimberly-Clark) is used compared to control (no microbial sealant).
1 secondary outcome
Subgroup incidence of SSI with and without microbial sealant
Time frame: 15 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Sep 2014.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Open Colorectal Surgery and Laparoscopic Surgery in people with Surgical Site Infection and SCIP, run by University of Southern California at 1 site in United States.
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 17 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: finished, as of the sponsor's last update on 16 Sep 2014. 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 United States. 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. Some participants in this study may receive a placebo. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of SSI with and without microbial sealant. (time frame: 15 Months). 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 16 Sep 2014.