Colorectal SurgeryNCT01233050
Efficacy Comparison of Two Preoperative Skin Antisepsis Preparations in Colorectal Surgery
A study testing 2% Chlorhexidine Gluconate/70% Isopropyl Alcohol and Iodine Povacrylex/74% Isopropyl Alcohol in people with Colorectal Surgery, run by University of Pennsylvania at 3 sites in United States.
Trial summary
Surgical site infections (SSI) are one of the most common complications in the post-operative patient, and the second most common health care associated infection overall. It is estimated that there are between 500 thousand and 1.1 million surgical site infections in the United States each year. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Colorectal Surgery
- What is being tested?
- 2% Chlorhexidine Gluconate/70% Isopropyl Alcohol and Iodine Povacrylex/74% Isopropyl Alcohol
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 802 participants
- Where
- 3 sitesUnited States
- Study dates
- Dec 2010to Feb 2015
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- 18 years or older, male or female
- Undergoing any large bowel procedure with an extraction incision site(including ileostomy closure and Hartman's colostomy reversals).
- A clean-contaminated preoperative classification.
- Patient must have decision-making capacity and undergo appropriate informed consent process.
- Non-pregnant or post menopausal or surgically sterilized females. If of child-bearing age, patients must have a negative (serum or urine) pregnancy prior to surgery.
Who cannot join
- Antibiotics taken within 5 days prior to surgery.
- Infected wound classification.
- Preoperative evaluation that may preclude full closure of the skin.
- Undergoing any bowel procedure that will not result in an extraction incision.
- Ongoing radiation or chemotherapy treatment.
- Pregnant.
Show all 14Show fewer
- Refusal to accept medically indicated blood products.
- Current abdominal wall infection or surgical site infection from previous laparotomy / laparoscopy.
- History of laparotomy within the last 60 days.
- Known allergy to iodine or to chlorhexidine gluconate.
- Participating in a preoperative antibiotic trial.
- Participating in a skin antisepsis trial.
- Participating in Ulcerative colitis trial conflicting with this trial.
- Women who are breast feeding (potential for transient hypothyroidism in the nursing newborn).
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Hospital of the University of Pennsylvania
Philadelphia, Pennsylvania, 19104
Penn Presbyterian Medical Center
Philadelphia, Pennsylvania, 19104
Pennsylvania Hospital
Philadelphia, Pennsylvania, 19106
About this study
Official title: A Randomized Double-Blind Study of 2% Chlorhexidine Gluconate / 70% Isopropyl Alcohol vs Iodine Povacrylex [0.7% Available Iodine] / 74% Isopropyl Alcohol for Perioperative Skin Preparation in Open Elective Colorectal Surgery
Surgical site infections (SSI) are one of the most common complications in the post-operative patient, and the second most common health care associated infection overall. It is estimated that there are between 500 thousand and 1.1 million surgical site infections in the United States each year. Given the magnitude of the problem, prevention of surgical site infections is a major goal of peri-operative care. However, skin preparation prior to surgery has not been as rigorously examined. The primary objective of this study is to compare the efficacy of two FDA approved, popular peri-operative skin preparations 2% chlorhexidine gluconate / 70% isopropyl alcohol to Iodine Povacrylex [0.7% available Iodine] / 74% Isopropyl Alcohol in the prevention of superficial surgical site infection. Male and female patients, age 18 years and older undergoing elective colorectal surgical procedures involving a laparotomy will be enrolled. These patients are at high risk of SSI. Eligible patients will be assessed at regular intervals for SSI and characterization of bacterial pathogen(s) in patients with SSI. Patients will remain enrolled into the study until 35 days postoperatively.
- Conditions
- Colorectal Surgery
- Being tested
- 2% Chlorhexidine Gluconate/70% Isopropyl Alcohol, Iodine Povacrylex/74% Isopropyl Alcohol
- Keywords
- undergoing elective colon and /or rectal surgical procedures involving an abdominal incision
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
2% Chlorhexidine Gluconate/70% Isopropyl AlcoholDrug
Also called ChloraPrep
Preoperative skin antisepsis preparation
Iodine Povacrylex/74% Isopropyl AlcoholDrug
Also called DuraPrep
preoperative skin antisepsis preparation
| Study group | Role | What they receive |
|---|---|---|
| 2% Chlorhexidine Gluconate/70% Isopropyl Alcohol | Active comparator | Preoperative Skin Antisepsis Preparation Receives: Drug: 2% Chlorhexidine Gluconate/70% Isopropyl Alcohol |
| Iodine Povacrylex/74% Isopropyl Alcohol | Active comparator | Preoperative Skin Antisepsis Preparation Receives: Drug: Iodine Povacrylex/74% Isopropyl Alcohol |
What is being measured
The primary outcome is the main question the study is designed to answer.
The Primary Objective Measures the Proportion of Patients With Superficial Site Infection as Defined by the CDC.
The primary objective compares the efficacy of 2% chlorhexidine gluconate / 70% isopropyl alcohol (ChloraPrep) to Iodine Povacrylex [0.7% available Iodine] / 74% Isopropyl Alcohol (DuraPrep) in the prevention of superficial surgical site infection. The primary objective will be measured by the number and percentage of patients with superficial site infection as defined by the CDC.
Measured: within 35 days of randomization to treatment assignment
Secondary outcomes (5)
Time to Develop Surgical Site Infection
average time from surgery to surgical site infection diagnosis
Measured: within 35 days of randomization to treatment assignment
Bacterial Pathogens Present in Documented Surgical Site Infection
Measured: within 35 days of randomization to treatment assignment
Number and Percentage of Participants With Deep Wound Infection
Measured: within 35 days of randomization to treatment assignment
Number and Percentage of Participants With Organ Space Infection
Measured: within 35 days of randomization to treatment assignment
Length of Hospital Stay
Measured: within 35 days of randomization to treatment assignment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Nov 2010 (estimated)
- Study startDec 2010
- Primary completionFeb 2015
- Study completionFeb 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Colorectal SurgeryStudies of the same condition, open and under way.
- More trials run by University of PennsylvaniaThe 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 N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 802 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Pennsylvania
- Sponsor type
- University, hospital or other
- Collaborators
- 3M
- Responsible party
- Sponsor
- Investigators
- Najjia N Mahmoud, MD, Principal investigator, University of Pennsylvania
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01233050
- Sponsor's protocol ID
- EM-05-012087
- Status last verified
- Jun 2018
- First submitted
- 22 Oct 2010
- Last updated
- 18 Jul 2018
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- Individual data sharing
- No
Publications
Broach RB, Paulson EC, Scott C, Mahmoud NN. Randomized Controlled Trial of Two Alcohol-based Preparations for Surgical Site Antisepsis in Colorectal Surgery. Ann Surg. 2017 Dec;266(6):946-951. doi: 10.1097/SLA.0000000000002189.
PubMed 28277409Poulin P, Chapman K, McGahan L, Austen L, Schuler T. Preoperative skin antiseptics for preventing surgical site infections: what to do? ORNAC J. 2014 Sep;32(3):12-5, 24-9.
PubMed 25322531
Study at a glance
From the registry record, last updated by the sponsor on 18 Jul 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Double-Blind Study of 2% Chlorhexidine Gluconate / 70% Isopropyl Alcohol vs Iodine Povacrylex [0.7% Available Iodine] / 74% Isopropyl Alcohol for Perioperative Skin Preparation in Open Elective Colorectal Surgery
- ClinicalTrials.gov ID
- NCT01233050
- Acronym / sponsor ID
- EM-05-012087
- Conditions
- Colorectal Surgery
- Keywords
- undergoing elective colon and /or rectal surgical procedures involving an abdominal incision
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 802 participants (actual)
- Lead sponsor
- University of PennsylvaniaUniversity, hospital or other
- Collaborators
- 3M
- Study start
- Dec 2010
- Primary completion
- Feb 2015 (actual)
- Study completion
- Feb 2015 (actual)
- First posted
- 2 Nov 2010 (estimated)
- Results
- Posted 5 Sep 2017
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 one of the most common complications in the post-operative patient, and the second most common health care associated infection overall. It is estimated that there are between 500 thousand and 1.1 million surgical site infections in the United States each year. Given the magnitude of the problem, prevention of surgical site infections is a major goal of peri-operative care. However, skin preparation prior to surgery has not been as rigorously examined. The primary objective of this study is to compare the efficacy of two FDA approved, popular peri-operative skin preparations 2% chlorhexidine gluconate / 70% isopropyl alcohol to Iodine Povacrylex [0.7% available Iodine] / 74% Isopropyl Alcohol in the prevention of superficial surgical site infection. Male and female patients, age 18 years and older undergoing elective colorectal surgical procedures involving a laparotomy will be enrolled. These patients are at high risk of SSI. Eligible patients will be assessed at regular intervals for SSI and characterization of bacterial pathogen(s) in patients with SSI. Patients will remain enrolled into the study until 35 days postoperatively.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 2% Chlorhexidine Gluconate/70% Isopropyl Alcohol | Active comparator | Drug: 2% Chlorhexidine Gluconate/70% Isopropyl AlcoholPreoperative Skin Antisepsis Preparation |
| Iodine Povacrylex/74% Isopropyl Alcohol | Active comparator | Drug: Iodine Povacrylex/74% Isopropyl AlcoholPreoperative Skin Antisepsis Preparation |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 18 years or older, male or female
- Undergoing any large bowel procedure with an extraction incision site(including ileostomy closure and Hartman's colostomy reversals).
- A clean-contaminated preoperative classification.
- Patient must have decision-making capacity and undergo appropriate informed consent process.
- Non-pregnant or post menopausal or surgically sterilized females. If of child-bearing age, patients must have a negative (serum or urine) pregnancy prior to surgery.
Key exclusion criteria (14 listed)
- Antibiotics taken within 5 days prior to surgery.
- Infected wound classification.
- Preoperative evaluation that may preclude full closure of the skin.
- Undergoing any bowel procedure that will not result in an extraction incision.
- Ongoing radiation or chemotherapy treatment.
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% Chlorhexidine Gluconate/70% Isopropyl AlcoholAlso: ChloraPrepPreoperative skin antisepsis preparation | Drug | 2% Chlorhexidine Gluconate/70% Isopropyl Alcohol |
| Iodine Povacrylex/74% Isopropyl AlcoholAlso: DuraPreppreoperative skin antisepsis preparation | Drug | Iodine Povacrylex/74% Isopropyl Alcohol |
Primary outcome
The Primary Objective Measures the Proportion of Patients With Superficial Site Infection as Defined by the CDC.
Time frame: within 35 days of randomization to treatment assignment
The primary objective compares the efficacy of 2% chlorhexidine gluconate / 70% isopropyl alcohol (ChloraPrep) to Iodine Povacrylex [0.7% available Iodine] / 74% Isopropyl Alcohol (DuraPrep) in the prevention of superficial surgical site infection. The primary objective will be measured by the number and percentage of patients with superficial site infection as defined by the CDC.
5 secondary outcomes
Time to Develop Surgical Site Infection
Time frame: within 35 days of randomization to treatment assignment
Bacterial Pathogens Present in Documented Surgical Site Infection
Time frame: within 35 days of randomization to treatment assignment
Number and Percentage of Participants With Deep Wound Infection
Time frame: within 35 days of randomization to treatment assignment
Number and Percentage of Participants With Organ Space Infection
Time frame: within 35 days of randomization to treatment assignment
Length of Hospital Stay
Time frame: within 35 days of randomization to treatment assignment
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jul 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 28277409Broach RB, Paulson EC, Scott C, Mahmoud NN. Randomized Controlled Trial of Two Alcohol-based Preparations for Surgical Site Antisepsis in Colorectal Surgery. Ann Surg. 2017 Dec;266(6):946-951. doi: 10.1097/SLA.0000000000002189.
- Derived from this study: PubMed 25322531Poulin P, Chapman K, McGahan L, Austen L, Schuler T. Preoperative skin antiseptics for preventing surgical site infections: what to do? ORNAC J. 2014 Sep;32(3):12-5, 24-9.
- Individual participant dataSharing planned: No
Related trials for Colorectal Surgery
Not yet recruiting
Tailored Nutrition vs. Exercise Prehabilitation Before Colorectal Cancer Surgery
Colorectal Cancer, Colorectal Neoplasms
Not yet recruiting
Nurse-Led Prehabilitation Before Major Abdominal Cancer Surgery
Colorectal Cancer
RecruitingPhase 1
Individual Response to Hyperthermic Intraperitoneal Chemotherapy (HIPEC) Treatment of Peritoneal Carcinomatosis From Peritoneal Mesothelioma or Atypical Mesothelial Proliferation or From Ovarian, Colorectal, or Appendiceal Histologies
Peritoneal Mesothelioma, Peritoneal Carcinomatosis
RecruitingObservational study
Evaluation for NCI Surgery Branch Clinical Research Protocols
Synovial Cell Cancer, Melanoma
RecruitingPhase 2
Testing the Addition of Total Ablative Therapy to Usual Systemic Therapy Treatment for Limited Metastatic Colorectal Cancer, ERASur Trial
Metastatic Colorectal Adenocarcinoma, Stage IV Colorectal Cancer AJCC v8
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.
Najjia N Mahmoud, MD principal investigator
University of Pennsylvania
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 2% Chlorhexidine Gluconate/70% Isopropyl Alcohol and Iodine Povacrylex/74% Isopropyl Alcohol in people with Colorectal Surgery, run by University of Pennsylvania at 3 sites 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 5 inclusion and 14 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 18 Jul 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 5 Sep 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
The Primary Objective Measures the Proportion of Patients With Superficial Site Infection as Defined by the CDC. (time frame: within 35 days of randomization to treatment assignment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01233050, which also lists 2 linked publications.
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 18 Jul 2018.