Skin Preparation for Elective Foot and Ankle Surgery
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Hibiclens, Isopropyl Alcohol 70% Topical Application Solution.
- Who it may be relevant to
- Registry conditions: Microbial Colonization, Foot and Ankle Disorders. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
Surgical site infections (SSIs) make about 31% of all nosocomial infections and they are the most common hospital-acquired infection. For foot and ankle elective interventions, SSI rate is reported between 0.4% and 3.6%. This study will investigate the effectiveness of skin cleaning with isopropyl alcohol and scrubbing with chlorhexidine soap before standard skin preparation in reducing microbial load and surgical site infections for elective foot and ankle surgeries. Current standard of care includes skin preparation with iodine or chlorhexidine solution prior to sterile draping and the start of surgery. Standard of care will be applied to all patients. The use of an additional "pre-scrub" with isopropyl alcohol and scrubbing with chlorhexidine soap will be applied to the experimental group. The control group will receive only the standard of care skin preparation with iodine or chlorhexidine solution prior to draping.
Interventions
- Drug Hibiclens
antiseptic/antimicrobial skin cleanser for skin wound and general skin cleansing - Drug Isopropyl Alcohol 70% Topical Application Solution
First aid antiseptic
Primary outcome measures
- Surgical Site Infection [Time frame: 90 days]
Secondary outcome measures (1)
- Microbial Load [Time frame: 90 days]
Eligibility criteria
Inclusion criteria
- patients undergoing elective foot and ankle surgeries
- age over 18
Exclusion criteria
- trauma as the indication for surgery
- open injuries
- non-elective procedures
- amputations
- prior surgical site infection through the planned incision
- pregnancy. All potential participants of child-bearing potential follow the standard pre-operative protocol to ensure they are not in pregnant status prior to SOC surgical procedure.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Double blind
- Primary purpose
- Other
Study locations
United States · 1 center
- University of Missouri — Columbia
Identifiers
NCT: NCT05401292 · 2074962