Postoperative InfectionNCT03926208
Dilute Betadine Soak and Scrub for Foot and Ankle Surgery
A study testing Soak and Scrub and Clorhexadine scrub in people with Postoperative Infection and Postoperative Complications, run by Rush University Medical Center at 1 site in United States.
Trial summary
Infection and wound complications are the most common complications following orthopaedic foot and ankle procedures, and the infection rate following these procedures is higher than in procedures involving other areas of the body.The purpose of this randomized controlled trial is to determine whether a standard… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Postoperative Infection, Postoperative Complications
- What is being tested?
- Soak and Scrub and Clorhexadine scrub
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 242 participants
- Where
- 1 siteUnited States
- Study dates
- 24 May 2019to 1 Jan 2020
- 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- ≥ 18 years of age
- Patient requires a foot or ankle operative procedure
- Patient provides informed consent
Who cannot join
- Patient refuses
- Patient is incarcerated, incapacitated, or otherwise unable to provide appropriate informed consent
Trial locations and contacts
1 site in 1 country.
United States1 site
Rush University Medical Center
Chicago, Illinois, 60612
About this study
Official title: Randomized Trial of Dilute Betadine Soak and Scrub for Foot and Ankle Surgery
Infection and wound complications are the most common complications following orthopaedic foot and ankle procedures, and the infection rate following these procedures is higher than in procedures involving other areas of the body.The purpose of this randomized controlled trial is to determine whether a standard chlorhexidine prep can be augmented with a soak \& scrub of the foot in dilute betadine to reduce the rate of positive cultures from the hallux nail fold prior to surgery.
Read the detailed description
Infection and wound complications are the most common complications following orthopaedic foot and ankle procedures, and the infection rate following these procedures is higher than in procedures involving other areas of the body. This is at least in part because the anatomy of the human foot presents inherent challenges for preoperative sterilization techniques due to the many folds and crevices associated with the toes. In particular, the nail folds of the toes are known to harbor large amounts of bacteria.
A systematic review and meta-analysis of previous studies that have investigated the efficacy of various foot and ankle preparation agents (including alcohol, chlorhexidine, chloroxylenol, and iodine/iodophors) showed that no single agent or combination of agents eliminates positive culture growth to undetectable levels for all patients. Articles have suggested superiority of a chlorhexidine prep solution over other types of preps; hence, chlorhexidine prep is now considered the gold standard at many institutions. But even a chlorhexidine prepped foot has been shown to contain culturable bacteria in the nail folds in 30% of cases.
The purpose of this randomized controlled trial is to determine whether a standard chlorhexidine prep can be augmented with a soak \& scrub in dilute betadine to reduce the rate of positive cultures from the hallux nail fold.
It is hypothesized that in comparison to feet receiving the standard chlorhexadine prep, feet receiving the standard prep plus the betadine soak \& scrub will be less likely to have culture positive swabs of the hallux nail fold.
- Being tested
- Soak and Scrub, Clorhexadine scrub
- Keywords
- Betadine, Foot, Ankle, Nail fold, Scrub, Infection, Prevention, Postoperative
- Medical subject headings
- Postoperative Complications, Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Soak and ScrubProcedure or surgery
Betadine soak and scrub in addition to standard clorhexadine scrub (standard of care).
Clorhexadine scrubProcedure or surgery
Clorhexadine scrub (standard of care).
| Study group | Role | What they receive |
|---|---|---|
| Control | Active comparator | Subjects in this group will receive the standard chlorhexadine prep of the foot (standard of care) prior to surgery, and a cotton swab will be collected from the hallux nail fold. Receives: Procedure: Clorhexadine scrub |
| Soak and Scrub | Experimental | In addition to the standard chlorhexadine prep of the foot prior to surgery, subjects in this group will also receive a betadine soak and scrub of the foot, and a cotton swab will be collected from the hallux nail fold. Receives: Procedure: Soak and Scrub |
What is being measured
The primary outcome is the main question the study is designed to answer.
Bacterial Culture Growth
Cotton swab of hallux nail fold. Culture of any microorganisms found. The results indicate the number of patients with positive bacterial culture growth.
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Apr 2019
- Study start24 May 2019
- Primary completion10 Dec 2019
- Study completion1 Jan 2020
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 (7)Papers the sponsor has linked to this study.
- Other trials for Postoperative InfectionStudies of the same condition, open and under way.
- More trials run by Rush University Medical CenterThe 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
- Model description
- One group will be randomized to receive a betadine soak and scrub (in addition to the standard of care) prior to surgery. The control group will receive the standard of care.
- Masking
- None (open label)
- Enrolment
- 242 participants (actual)
Sponsor and investigators
- Lead sponsor
- Rush University Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kamran S Hamid, MD, Rush University Medical Center
- Investigators
- Kamran S Hamid, MD, Principal investigator, Rush University Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03926208
- Sponsor's protocol ID
- 18021801-IRB02
- Status last verified
- Jan 2021
- First submitted
- 22 Apr 2019
- Last updated
- 12 Feb 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: IPD will not be made available to other researchers.
Publications
Butterworth P, Gilheany MF, Tinley P. Postoperative infection rates in foot and ankle surgery: a clinical audit of Australian podiatric surgeons, January to December 2007. Aust Health Rev. 2010 May;34(2):180-5. doi: 10.1071/AH08687.
PubMed 20497730Donley BG, Philbin T, Tomford JW, Sferra JJ. Foot and ankle infections after surgery. Clin Orthop Relat Res. 2001 Oct;(391):162-70. doi: 10.1097/00003086-200110000-00017.
PubMed 11603664Physiology for Nursing Practice Physiology for Nursing Practice edited by Hinchcliff S Montague S Published by Bailliere Tindall 680pp pound9.95 0-7020-1194-0 [Formula: see text]. Nurs Stand. 1988 May 21;2(33):34. doi: 10.7748/ns.2.33.34.s62.
PubMed 27416219Hunter JG, Dawson LK, Soin SP, Baumhauer JF. Randomized, Prospective Study of the Order of Preoperative Preparation Solutions for Patients Undergoing Foot and Ankle Orthopedic Surgery. Foot Ankle Int. 2016 May;37(5):478-82. doi: 10.1177/1071100715623037. Epub 2015 Dec 17.
PubMed 26678427Ostrander 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 15866959Sands K, Vineyard G, Platt R. Surgical site infections occurring after hospital discharge. J Infect Dis. 1996 Apr;173(4):963-70. doi: 10.1093/infdis/173.4.963.
PubMed 8603978Yammine K, Harvey A. Efficacy of preparation solutions and cleansing techniques on contamination of the skin in foot and ankle surgery: A systematic review and meta-analysis. Bone Joint J. 2013 Apr;95-B(4):498-503. doi: 10.1302/0301-620X.95B4.30893.
PubMed 23653955
Study at a glance
From the registry record, last updated by the sponsor on 12 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Trial of Dilute Betadine Soak and Scrub for Foot and Ankle Surgery
- ClinicalTrials.gov ID
- NCT03926208
- Acronym / sponsor ID
- 18021801-IRB02
- Keywords
- Betadine, Foot, Ankle, Nail fold, Scrub, Infection, Prevention, Postoperative
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 242 participants (actual)
- Lead sponsor
- Rush University Medical CenterUniversity, hospital or other
- Study start
- 24 May 2019 (actual)
- Primary completion
- 10 Dec 2019 (actual)
- Study completion
- 1 Jan 2020 (actual)
- First posted
- 24 Apr 2019 (actual)
- Results
- Posted 12 Feb 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Infection and wound complications are the most common complications following orthopaedic foot and ankle procedures, and the infection rate following these procedures is higher than in procedures involving other areas of the body.The purpose of this randomized controlled trial is to determine whether a standard chlorhexidine prep can be augmented with a soak \& scrub of the foot in dilute betadine to reduce the rate of positive cultures from the hallux nail fold prior to surgery.
Detailed description
Infection and wound complications are the most common complications following orthopaedic foot and ankle procedures, and the infection rate following these procedures is higher than in procedures involving other areas of the body. This is at least in part because the anatomy of the human foot presents inherent challenges for preoperative sterilization techniques due to the many folds and crevices associated with the toes. In particular, the nail folds of the toes are known to harbor large amounts of bacteria.
A systematic review and meta-analysis of previous studies that have investigated the efficacy of various foot and ankle preparation agents (including alcohol, chlorhexidine, chloroxylenol, and iodine/iodophors) showed that no single agent or combination of agents eliminates positive culture growth to undetectable levels for all patients. Articles have suggested superiority of a chlorhexidine prep solution over other types of preps; hence, chlorhexidine prep is now considered the gold standard at many institutions. But even a chlorhexidine prepped foot has been shown to contain culturable bacteria in the nail folds in 30% of cases.
The purpose of this randomized controlled trial is to determine whether a standard chlorhexidine prep can be augmented with a soak \& scrub in dilute betadine to reduce the rate of positive cultures from the hallux nail fold.
It is hypothesized that in comparison to feet receiving the standard chlorhexadine prep, feet receiving the standard prep plus the betadine soak \& scrub will be less likely to have culture positive swabs of the hallux nail fold.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- One group will be randomized to receive a betadine soak and scrub (in addition to the standard of care) prior to surgery. The control group will receive the standard of care.
| Arm | Type | Receives |
|---|---|---|
| Control | Active comparator | Procedure: Clorhexadine scrubSubjects in this group will receive the standard chlorhexadine prep of the foot (standard of care) prior to surgery, and a cotton swab will be collected from the hallux nail fold. |
| Soak and Scrub | Experimental | Procedure: Soak and ScrubIn addition to the standard chlorhexadine prep of the foot prior to surgery, subjects in this group will also receive a betadine soak and scrub of the foot, and a cotton swab will be collected from the hallux nail fold. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- ≥ 18 years of age
- Patient requires a foot or ankle operative procedure
- Patient provides informed consent
Key exclusion criteria (2 listed)
- Patient refuses
- Patient is incarcerated, incapacitated, or otherwise unable to provide appropriate informed consent
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 |
|---|---|---|
| Soak and ScrubBetadine soak and scrub in addition to standard clorhexadine scrub (standard of care). | Procedure or surgery | Soak and Scrub |
| Clorhexadine scrubClorhexadine scrub (standard of care). | Procedure or surgery | Control |
Primary outcome
Bacterial Culture Growth
Time frame: 1 day
Cotton swab of hallux nail fold. Culture of any microorganisms found. The results indicate the number of patients with positive bacterial culture growth.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Feb 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 20497730Butterworth P, Gilheany MF, Tinley P. Postoperative infection rates in foot and ankle surgery: a clinical audit of Australian podiatric surgeons, January to December 2007. Aust Health Rev. 2010 May;34(2):180-5. doi: 10.1071/AH08687.
- Background: PubMed 11603664Donley BG, Philbin T, Tomford JW, Sferra JJ. Foot and ankle infections after surgery. Clin Orthop Relat Res. 2001 Oct;(391):162-70. doi: 10.1097/00003086-200110000-00017.
- Background: PubMed 27416219Physiology for Nursing Practice Physiology for Nursing Practice edited by Hinchcliff S Montague S Published by Bailliere Tindall 680pp pound9.95 0-7020-1194-0 [Formula: see text]. Nurs Stand. 1988 May 21;2(33):34. doi: 10.7748/ns.2.33.34.s62.
- Background: PubMed 26678427Hunter JG, Dawson LK, Soin SP, Baumhauer JF. Randomized, Prospective Study of the Order of Preoperative Preparation Solutions for Patients Undergoing Foot and Ankle Orthopedic Surgery. Foot Ankle Int. 2016 May;37(5):478-82. doi: 10.1177/1071100715623037. Epub 2015 Dec 17.
- 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 8603978Sands K, Vineyard G, Platt R. Surgical site infections occurring after hospital discharge. J Infect Dis. 1996 Apr;173(4):963-70. doi: 10.1093/infdis/173.4.963.
- Background: PubMed 23653955Yammine K, Harvey A. Efficacy of preparation solutions and cleansing techniques on contamination of the skin in foot and ankle surgery: A systematic review and meta-analysis. Bone Joint J. 2013 Apr;95-B(4):498-503. doi: 10.1302/0301-620X.95B4.30893.
- Individual participant dataSharing planned: No. IPD will not be made available to other researchers.
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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.
Kamran S Hamid, MD principal investigator
Rush University Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Soak and Scrub and Clorhexadine scrub in people with Postoperative Infection and Postoperative Complications, run by Rush University Medical Center 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 2 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 12 Feb 2021. 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.
Are results available for this study?
Yes. Results are posted in the registry (first posted 12 Feb 2021). 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?
Bacterial Culture Growth (time frame: 1 day). 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 NCT03926208, which also lists 7 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 12 Feb 2021.