Trial Outcomes & Findings for Dilute Betadine Soak and Scrub for Foot and Ankle Surgery (NCT NCT03926208)

NCT ID: NCT03926208

Last Updated: 2021-02-12

Results Overview

Cotton swab of hallux nail fold. Culture of any microorganisms found. The results indicate the number of patients with positive bacterial culture growth.

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 242 participants
• Primary outcome timeframe: 1 day
• Results posted on: 2021-02-12

Participant Flow

Patients were enrolled until protocol requirements were met.

Participant milestones

Measure	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).	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).
Overall Study STARTED	119	123
Overall Study COMPLETED	119	123
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Measure	Control n=119 Participants 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).	Intervention n=123 Participants 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).	Total n=242 Participants Total of all reporting groups
Age, Continuous	48.2 years STANDARD_DEVIATION 16.5 • n=119 Participants	51.2 years STANDARD_DEVIATION 16.5 • n=123 Participants	49.5 years STANDARD_DEVIATION 16.5 • n=242 Participants
Sex: Female, Male Female	66 Participants n=119 Participants	69 Participants n=123 Participants	135 Participants n=242 Participants
Sex: Female, Male Male	53 Participants n=119 Participants	54 Participants n=123 Participants	107 Participants n=242 Participants
Race and Ethnicity Not Collected	—	—	0 Participants Race and Ethnicity were not collected from any participant.
Region of Enrollment United States	119 participants n=119 Participants	123 participants n=123 Participants	242 participants n=242 Participants
Body mass index	29.2 kg/m2 STANDARD_DEVIATION 6.8 • n=119 Participants	29.3 kg/m2 STANDARD_DEVIATION 7.1 • n=123 Participants	29.2 kg/m2 STANDARD_DEVIATION 7.0 • n=242 Participants
Splint	28 Participants n=119 Participants	27 Participants n=123 Participants	55 Participants n=242 Participants

PRIMARY outcome

Timeframe: 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.

Outcome measures

Measure	Control n=119 Participants 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).	Intervention n=123 Participants 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).
Bacterial Culture Growth	32 Participants	33 Participants

Adverse Events

Control

Serious events: 0 serious events

Other events: 8 other events

Deaths: 0 deaths

Intervention

Serious events: 0 serious events

Other events: 9 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	Control n=119 participants at risk 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).	Intervention n=123 participants at risk 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).
Musculoskeletal and connective tissue disorders Deep SSI	0.00% 0/119 • 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.	0.00% 0/123 • 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.
Musculoskeletal and connective tissue disorders Superficial Surgical Site Infection	6.7% 8/119 • Number of events 8 • 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.	7.3% 9/123 • Number of events 9 • 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.

Additional Information

Dr. Daniel D. Bohl

Rush University Medical Center

Phone: 414.640.7245

Email: danielbohl@gmail.com

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place