Lower Extremity SurgeryPhase 4NCT02017145
Study on the Reapplication of Chloraprep After Lower Extremity Surgery and Prior to Dressing Application
A Phase 4 study testing Chloraprep in people with Lower Extremity Surgery and Surgical Site Infection, run by Sanford Health at 1 site in United States.
Trial summary
The purpose of the current work is to determine the efficacy of the re-application of surgical prep solution in decreasing surgical site bacterial contamination following lower extremity surgery. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lower Extremity Surgery, Surgical Site Infection, Bacterial Colonization
- What is being tested?
- Chloraprep
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 140 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2014to Feb 2015
- 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
- Male and female
- Adults (18+)
- Both elective and non-elective procedures
- Lower extremity surgery performed below the knee and requiring post-operative splint immobilization for 2-3 weeks
- Able to understand and read the English language
- Signed informed consent
Who cannot join
- Pregnant (to be assessed the day of surgery per standard of care surgical protocol)
- Known allergies to chlorhexidine gluconate or isopropyl alcohol
- Multiple planned lower extremity surgeries
- Local skin disease
- Pre-existing or known infection at surgical site
- Open wounds or local abrasions
- Unable to or unwilling to follow through with study requirements
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
Sanford USD Medical Center
Sioux Falls, South Dakota, 57117
Kyle T Judd, MD, 605-328-2663, kyle.judd@sanfordhealth.org
Kyle T Judd, MD
About this study
Official title: Role of Post-operative Re-application of Chloraprep® Following Lower Extremity Surgeries on Surgical Site Bacterial Colonization.
The purpose of the current work is to determine the efficacy of the re-application of surgical prep solution in decreasing surgical site bacterial contamination following lower extremity surgery. Decreasing the extent of bacterial colonization of the skin surrounding the surgical site during the initial healing phases would theoretically decrease the rate of infection in high-risk persons.
- Conditions
- Lower Extremity Surgery, Surgical Site Infection, Bacterial Colonization, Surgical Antiseptic
- Being tested
- Chloraprep
- Keywords
- infection, chloraprep, chlorhexidine, lower extremity surgery, antiseptic, bacterial colonization
- Medical subject headings
- Surgical Wound Infection, Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ChloraprepDrug
| Study group | Role | What they receive |
|---|---|---|
| no reapplication | No intervention | This group will not have chloraprep reapplied after their surgery and prior to dressing application. |
| reapplication | Experimental | This group will have chloraprep reapplied following their lower extremity surgical procedure and prior to dressing application. Receives: Drug: Chloraprep |
What is being measured
The primary outcome is the main question the study is designed to answer.
quantitative bacterial colonization
Compare the number of colony forming units taken from culture swabs immediately adjacent to the wound during dressing change between the two arms
Measured: 14-21 days
positive culture rate
Compare the overall positive culture rate between the two treatment groups
Measured: 14-21 days
Secondary outcomes (1)
bacterial strain identification
Assess the total number of bacterial strains and identifying those strains cultured from swabs taken immediately adjacent to the wound during dressing change
Measured: 14-21 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Dec 2013 (estimated)
- Study startFeb 2014
- Primary completionFeb 2015 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Lower Extremity SurgeryStudies 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
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 140 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sanford Health
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kyle Judd, Sanford Health
- Investigators
- Kyle T Judd, MD, Principal investigator, Sanford Orthopedics and Sports Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02017145
- Sponsor's protocol ID
- SH Chloraprep reapplication
- Status last verified
- Feb 2014
- First submitted
- 16 Dec 2013
- Last updated
- 19 Feb 2014
- Results posted
- No
- Data monitoring committee
- No
Publications
Gould D. Causes, prevention and management of surgical site infection. Nurs Stand. 2012 Jul 25-31;26(47):47-56; quiz 58. doi: 10.7748/ns2012.07.26.47.47.c9226.
PubMed 22913092Ostrander RV, Botte MJ, Brage ME. Efficacy of surgical preparation solutions in foot and ankle surgery. J Bone Joint Surg Am. 2005 May;87(5):980-5. doi: 10.2106/JBJS.D.01977.
PubMed 15866959Darouiche RO, Wall MJ Jr, Itani KM, Otterson MF, Webb AL, Carrick MM, Miller HJ, Awad SS, Crosby CT, Mosier MC, Alsharif A, Berger DH. Chlorhexidine-Alcohol versus Povidone-Iodine for Surgical-Site Antisepsis. N Engl J Med. 2010 Jan 7;362(1):18-26. doi: 10.1056/NEJMoa0810988.
PubMed 20054046Hibbard JS. Analyses comparing the antimicrobial activity and safety of current antiseptic agents: a review. J Infus Nurs. 2005 May-Jun;28(3):194-207. doi: 10.1097/00129804-200505000-00008.
PubMed 15912075Hibbard JS, Mulberry GK, Brady AR. A clinical study comparing the skin antisepsis and safety of ChloraPrep, 70% isopropyl alcohol, and 2% aqueous chlorhexidine. J Infus Nurs. 2002 Jul-Aug;25(4):244-9. doi: 10.1097/00129804-200207000-00007.
PubMed 12131506
Study at a glance
From the registry record, last updated by the sponsor on 19 Feb 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Role of Post-operative Re-application of Chloraprep® Following Lower Extremity Surgeries on Surgical Site Bacterial Colonization.
- ClinicalTrials.gov ID
- NCT02017145
- Acronym / sponsor ID
- SH Chloraprep reapplication
- Conditions
- Lower Extremity Surgery, Surgical Site Infection, Bacterial Colonization, Surgical Antiseptic
- Keywords
- infection, chloraprep, chlorhexidine, lower extremity surgery, antiseptic, bacterial colonization
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 140 participants (estimated)
- Lead sponsor
- Sanford HealthUniversity, hospital or other
- Study start
- Feb 2014
- Primary completion
- Feb 2015 (estimated)
- First posted
- 20 Dec 2013 (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 of the current work is to determine the efficacy of the re-application of surgical prep solution in decreasing surgical site bacterial contamination following lower extremity surgery. Decreasing the extent of bacterial colonization of the skin surrounding the surgical site during the initial healing phases would theoretically decrease the rate of infection in high-risk persons.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| no reapplication | No intervention | –This group will not have chloraprep reapplied after their surgery and prior to dressing application. |
| reapplication | Experimental | Drug: ChloraprepThis group will have chloraprep reapplied following their lower extremity surgical procedure and prior to dressing application. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Male and female
- Adults (18+)
- Both elective and non-elective procedures
- Lower extremity surgery performed below the knee and requiring post-operative splint immobilization for 2-3 weeks
- Able to understand and read the English language
Key exclusion criteria (7 listed)
- Pregnant (to be assessed the day of surgery per standard of care surgical protocol)
- Known allergies to chlorhexidine gluconate or isopropyl alcohol
- Multiple planned lower extremity surgeries
- Local skin disease
- Pre-existing or known infection at surgical site
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 |
|---|---|---|
| Chloraprep | Drug | reapplication |
Primary outcome
quantitative bacterial colonization
Time frame: 14-21 days
Compare the number of colony forming units taken from culture swabs immediately adjacent to the wound during dressing change between the two arms
positive culture rate
Time frame: 14-21 days
Compare the overall positive culture rate between the two treatment groups
1 secondary outcome
bacterial strain identification
Time frame: 14-21 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Feb 2014.
- Background: PubMed 22913092Gould D. Causes, prevention and management of surgical site infection. Nurs Stand. 2012 Jul 25-31;26(47):47-56; quiz 58. doi: 10.7748/ns2012.07.26.47.47.c9226.
- Background: PubMed 15866959Ostrander RV, Botte MJ, Brage ME. Efficacy of surgical preparation solutions in foot and ankle surgery. J Bone Joint Surg Am. 2005 May;87(5):980-5. doi: 10.2106/JBJS.D.01977.
- Background: PubMed 20054046Darouiche RO, Wall MJ Jr, Itani KM, Otterson MF, Webb AL, Carrick MM, Miller HJ, Awad SS, Crosby CT, Mosier MC, Alsharif A, Berger DH. Chlorhexidine-Alcohol versus Povidone-Iodine for Surgical-Site Antisepsis. N Engl J Med. 2010 Jan 7;362(1):18-26. doi: 10.1056/NEJMoa0810988.
- Background: PubMed 15912075Hibbard JS. Analyses comparing the antimicrobial activity and safety of current antiseptic agents: a review. J Infus Nurs. 2005 May-Jun;28(3):194-207. doi: 10.1097/00129804-200505000-00008.
- Background: PubMed 12131506Hibbard JS, Mulberry GK, Brady AR. A clinical study comparing the skin antisepsis and safety of ChloraPrep, 70% isopropyl alcohol, and 2% aqueous chlorhexidine. J Infus Nurs. 2002 Jul-Aug;25(4):244-9. doi: 10.1097/00129804-200207000-00007.
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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.
Kyle T Judd, MD principal investigator
Sanford Orthopedics and Sports Medicine
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 Chloraprep in people with Lower Extremity Surgery and Surgical Site Infection, run by Sanford Health 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 6 inclusion and 7 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 19 Feb 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. 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 Jeremy P Morgan, MS (605-328-1398, jeremy.morgan@sanfordhealth.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
quantitative bacterial colonization (time frame: 14-21 days). The study lists 2 primary outcomes in all. 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 NCT02017145, which also lists 5 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 19 Feb 2014.