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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Soak and Scrub | Procedure | Betadine soak and scrub in addition to standard clorhexadine scrub (standard of care). |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 1 day |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Kamran S Hamid, MD | Rush University Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Rush University Medical Center | Chicago | Illinois | 60612 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 20497730 | Background | 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. | |
| 11603664 | Background | Donley 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. |
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IPD will not be made available to other researchers.
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Patients were enrolled until protocol requirements were met.
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| ID | Title | Description |
|---|---|---|
| FG000 | Control | 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. Clorhexadine scrub: Clorhexadine scrub (standard of care). |
| FG001 | Intervention | 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. Soak and Scrub: Betadine soak and scrub in addition to standard clorhexadine scrub (standard of care). |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Control | 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. Clorhexadine scrub: Clorhexadine scrub (standard of care). |
| BG001 | Intervention |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Posted | Count of Participants | Participants | 1 day |
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Adverse events were collected for the patients global period (3 months) from the surgery date.
Adverse events were monitored at every clinic visit after surgery.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Control | 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. Clorhexadine scrub: Clorhexadine scrub (standard of care). |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Deep SSI | Musculoskeletal and connective tissue disorders | Non-systematic Assessment | Deep SSI was defined as similar symptoms treated with incision and debridement in the operating room. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Daniel D. Bohl | Rush University Medical Center | 414.640.7245 | danielbohl@gmail.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP_ICF | Yes | Yes | Yes | Study Protocol, Statistical Analysis Plan, and Informed Consent Form | Apr 12, 2019 | Jan 25, 2021 | Prot_SAP_ICF_000.pdf |
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| ID | Term |
|---|---|
| D011183 | Postoperative Complications |
| D007239 | Infections |
| ID | Term |
|---|---|
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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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.
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| Clorhexadine scrub | Procedure | Clorhexadine scrub (standard of care). |
|
| 27416219 | Background | Physiology 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. |
| 26678427 | Background | Hunter 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. |
| 15866959 | Background | Ostrander 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. |
| 8603978 | Background | Sands 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. |
| 23653955 | Background | Yammine 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. |
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. Soak and Scrub: Betadine soak and scrub in addition to standard clorhexadine scrub (standard of care). |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Body mass index | Mean | Standard Deviation | kg/m2 |
|
| Splint | Count of Participants | Participants |
|
|
|
| 0 |
| 119 |
| 0 |
| 119 |
| 8 |
| 119 |
| EG001 | Intervention | 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. Soak and Scrub: Betadine soak and scrub in addition to standard clorhexadine scrub (standard of care). | 0 | 123 | 0 | 123 | 9 | 123 |
|
| Superficial Surgical Site Infection | Musculoskeletal and connective tissue disorders | Non-systematic Assessment | Superficial surgical site infections or wound at risk was defined as peri-incisional erythema, redness, dehiscence, and/or drainage that was managed with oral antibiotics on an outpatient basis |
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