Trial Outcomes & Findings for Chlorhexidine-Alcohol Versus Povidone-Iodine for Cesarean Antisepsis (NCT NCT02202577)

NCT ID: NCT02202577

Last Updated: 2022-07-21

Results Overview

Number of Patients with Cesarean-Related surgical site infection by Center for Disease Control (CDC) criteria: superficial, deep, organ space.

Recruitment status

COMPLETED

Study phase

Target enrollment

932 participants

Primary outcome timeframe

4 weeks after cesarean delivery

Results posted on

2022-07-21

Participant Flow

Recruitment and randomization began March 2014 and was successfully completed May 2016.

Participant milestones

Participant milestones
Measure	Chlorhexidine - Isopropyl Alcohol Pre-operative skin preparation with Chlorhexidine Gluconate- Isopropyl alcohol Chlorhexidine - Isopropyl alcohol: Applied to skin pre-operatively for surgical site anti-sepsis; regulated as a drug by FDA	Povidone-Iodine Scrub and Paint Pre-operative skin preparation with Povidone-Iodine Scrub and Paint Povidone-Iodine Scrub and Paint: Applied to skin pre-operatively for surgical site anti-sepsis; regulated as a drug by FDA
Overall Study STARTED	461	471
Overall Study COMPLETED	448	452
Overall Study NOT COMPLETED	13	19

Reasons for withdrawal

Reasons for withdrawal
Measure	Chlorhexidine - Isopropyl Alcohol Pre-operative skin preparation with Chlorhexidine Gluconate- Isopropyl alcohol Chlorhexidine - Isopropyl alcohol: Applied to skin pre-operatively for surgical site anti-sepsis; regulated as a drug by FDA	Povidone-Iodine Scrub and Paint Pre-operative skin preparation with Povidone-Iodine Scrub and Paint Povidone-Iodine Scrub and Paint: Applied to skin pre-operatively for surgical site anti-sepsis; regulated as a drug by FDA
Overall Study Lost to Follow-up	6	16
Overall Study Protocol Violation	7	3

Baseline Characteristics

Chlorhexidine-Alcohol Versus Povidone-Iodine for Cesarean Antisepsis

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Chlorhexidine - Isopropyl Alcohol n=461 Participants Pre-operative skin preparation with Chlorhexidine Gluconate- Isopropyl alcohol Chlorhexidine - Isopropyl alcohol: Applied to skin pre-operatively for surgical site anti-sepsis; regulated as a drug by FDA	Povidone-Iodine Scrub and Paint n=471 Participants Pre-operative skin preparation with Povidone-Iodine Scrub and Paint Povidone-Iodine Scrub and Paint: Applied to skin pre-operatively for surgical site anti-sepsis; regulated as a drug by FDA	Total n=932 Participants Total of all reporting groups
Age, Continuous	28 years n=99 Participants	28 years n=107 Participants	28 years n=206 Participants
Sex: Female, Male Female	461 Participants n=99 Participants	471 Participants n=107 Participants	932 Participants n=206 Participants
Sex: Female, Male Male	0 Participants n=99 Participants	0 Participants n=107 Participants	0 Participants n=206 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=99 Participants	0 Participants n=107 Participants	0 Participants n=206 Participants
Race (NIH/OMB) Asian	3 Participants n=99 Participants	6 Participants n=107 Participants	9 Participants n=206 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=99 Participants	0 Participants n=107 Participants	0 Participants n=206 Participants
Race (NIH/OMB) Black or African American	207 Participants n=99 Participants	210 Participants n=107 Participants	417 Participants n=206 Participants
Race (NIH/OMB) White	182 Participants n=99 Participants	186 Participants n=107 Participants	368 Participants n=206 Participants
Race (NIH/OMB) More than one race	0 Participants n=99 Participants	0 Participants n=107 Participants	0 Participants n=206 Participants
Race (NIH/OMB) Unknown or Not Reported	69 Participants n=99 Participants	69 Participants n=107 Participants	138 Participants n=206 Participants

PRIMARY outcome

Timeframe: 4 weeks after cesarean delivery

Number of Patients with Cesarean-Related surgical site infection by Center for Disease Control (CDC) criteria: superficial, deep, organ space.

Outcome measures

Outcome measures
Measure	Chlorhexidine - Isopropyl Alcohol n=461 Participants Pre-operative skin preparation with Chlorhexidine Gluconate- Isopropyl alcohol Chlorhexidine - Isopropyl alcohol: Applied to skin pre-operatively for surgical site anti-sepsis; regulated as a drug by FDA	Povidone-Iodine Scrub and Paint n=471 Participants Pre-operative skin preparation with Povidone-Iodine Scrub and Paint Povidone-Iodine Scrub and Paint: Applied to skin pre-operatively for surgical site anti-sepsis; regulated as a drug by FDA
Number of Patients With Surgical Site Infection	29 Participants	33 Participants

SECONDARY outcome

Timeframe: 4 weeks after cesarean delivery

Non-infection complications: allergic skin reactions, hematomas, wound separation, dehiscence.

Outcome measures

Outcome measures
Measure	Chlorhexidine - Isopropyl Alcohol n=461 Participants Pre-operative skin preparation with Chlorhexidine Gluconate- Isopropyl alcohol Chlorhexidine - Isopropyl alcohol: Applied to skin pre-operatively for surgical site anti-sepsis; regulated as a drug by FDA	Povidone-Iodine Scrub and Paint n=471 Participants Pre-operative skin preparation with Povidone-Iodine Scrub and Paint Povidone-Iodine Scrub and Paint: Applied to skin pre-operatively for surgical site anti-sepsis; regulated as a drug by FDA
Number of Patients With Non-infections Surgical Site Complications	19 Participants	17 Participants

Adverse Events

Chlorhexidine - Isopropyl Alcohol

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Povidone-Iodine Scrub and Paint

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Edward H Springel, MD

Virginia Commonwealth University Health System

Phone: 804-828-8468

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place