Trial Outcomes & Findings for Comparison of Surgical Skin Preps During Cesarean Deliveries (NCT NCT01870583)

NCT ID: NCT01870583

Last Updated: 2017-10-02

Results Overview

Surgical site infection will follow CDC guidelines: A) Superficial incisional surgical site infection B) Deep incisional surgical site infection or C) Organ/space surgical site infection.

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 1404 participants
• Primary outcome timeframe: 42 days after delivery
• Results posted on: 2017-10-02

Participant Flow

Participant milestones

Measure	Combination Iodine and Chlorhexidine The combincation skin preparation will utilize the iodine based preparation first followed by the chlorhexidine based skin preparation prior to cesarean delivery. Combination iodine and chlorhexidine: Combination iodine povidone and chlorhexidine skin preparation solution prior to cesarean delivery	Chlorhexidine Chlorhexidine based skin preparation solution applied to skin prior to cesarean delivery Chlorhexidine: Chlorhexidine skin preparation solution prior to cesarean delivery	Iodine Povidone Iodine povidone based skin preparation solution applied to skin prior to cesarean delivery Iodine povidone: Iodine skin preparation solution prior to cesarean delivery
Overall Study STARTED	467	474	463
Overall Study COMPLETED	456	456	455
Overall Study NOT COMPLETED	11	18	8

Reasons for withdrawal

Measure	Combination Iodine and Chlorhexidine The combincation skin preparation will utilize the iodine based preparation first followed by the chlorhexidine based skin preparation prior to cesarean delivery. Combination iodine and chlorhexidine: Combination iodine povidone and chlorhexidine skin preparation solution prior to cesarean delivery	Chlorhexidine Chlorhexidine based skin preparation solution applied to skin prior to cesarean delivery Chlorhexidine: Chlorhexidine skin preparation solution prior to cesarean delivery	Iodine Povidone Iodine povidone based skin preparation solution applied to skin prior to cesarean delivery Iodine povidone: Iodine skin preparation solution prior to cesarean delivery
Overall Study Protocol Violation	0	5	3
Overall Study Lost to Follow-up	11	13	5

Baseline Characteristics

Comparison of Surgical Skin Preps During Cesarean Deliveries

Baseline characteristics by cohort

Measure	Combination Iodine and Chlorhexidine n=467 Participants The combincation skin preparation will utilize the iodine based preparation first followed by the chlorhexidine based skin preparation prior to cesarean delivery. Combination iodine and chlorhexidine: Combination iodine povidone and chlorhexidine skin preparation solution prior to cesarean delivery	Chlorhexidine n=474 Participants Chlorhexidine based skin preparation solution applied to skin prior to cesarean delivery Chlorhexidine: Chlorhexidine skin preparation solution prior to cesarean delivery	Iodine Povidone n=463 Participants Iodine povidone based skin preparation solution applied to skin prior to cesarean delivery Iodine povidone: Iodine skin preparation solution prior to cesarean delivery	Total n=1404 Participants Total of all reporting groups
Age, Continuous	30.1 years STANDARD_DEVIATION 5.9 • n=5 Participants	30.3 years STANDARD_DEVIATION 5.7 • n=7 Participants	29.9 years STANDARD_DEVIATION 6.0 • n=5 Participants	30.2 years STANDARD_DEVIATION 5.7 • n=4 Participants
Sex: Female, Male Female	467 Participants n=5 Participants	474 Participants n=7 Participants	463 Participants n=5 Participants	1404 Participants n=4 Participants
Sex: Female, Male Male	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Region of Enrollment United States	467 participants n=5 Participants	474 participants n=7 Participants	463 participants n=5 Participants	1404 participants n=4 Participants

PRIMARY outcome

Timeframe: 42 days after delivery

Surgical site infection will follow CDC guidelines: A) Superficial incisional surgical site infection B) Deep incisional surgical site infection or C) Organ/space surgical site infection.

Outcome measures

Measure	Combination Iodine and Chlorhexidine n=467 Participants The combincation skin preparation will utilize the iodine based preparation first followed by the chlorhexidine based skin preparation prior to cesarean delivery. Combination iodine and chlorhexidine: Combination iodine povidone and chlorhexidine skin preparation solution prior to cesarean delivery	Chlorhexidine n=474 Participants Chlorhexidine based skin preparation solution applied to skin prior to cesarean delivery Chlorhexidine: Chlorhexidine skin preparation solution prior to cesarean delivery	Iodine Povidone n=463 Participants Iodine povidone based skin preparation solution applied to skin prior to cesarean delivery Iodine povidone: Iodine skin preparation solution prior to cesarean delivery
Cesarean Surgical Site Infection SSI: Deep	1 Participants	3 Participants	3 Participants
Cesarean Surgical Site Infection Any SSI: Total combined	18 Participants	21 Participants	21 Participants
Cesarean Surgical Site Infection SSI: Superficial	15 Participants	15 Participants	16 Participants
Cesarean Surgical Site Infection SSI: Organ	2 Participants	3 Participants	2 Participants

Adverse Events

Combination Iodine and Chlorhexidine

Serious events: 2 serious events

Other events: 0 other events

Deaths: 0 deaths

Chlorhexidine

Serious events: 3 serious events

Other events: 0 other events

Deaths: 0 deaths

Iodine Povidone

Serious events: 2 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Measure	Combination Iodine and Chlorhexidine n=467 participants at risk The combincation skin preparation will utilize the iodine based preparation first followed by the chlorhexidine based skin preparation prior to cesarean delivery. Combination iodine and chlorhexidine: Combination iodine povidone and chlorhexidine skin preparation solution prior to cesarean delivery	Chlorhexidine n=474 participants at risk Chlorhexidine based skin preparation solution applied to skin prior to cesarean delivery Chlorhexidine: Chlorhexidine skin preparation solution prior to cesarean delivery	Iodine Povidone n=463 participants at risk Iodine povidone based skin preparation solution applied to skin prior to cesarean delivery Iodine povidone: Iodine skin preparation solution prior to cesarean delivery
Infections and infestations Surgical site infection: organ	0.43% 2/467	0.63% 3/474	0.43% 2/463

Other adverse events

Adverse event data not reported

Additional Information

Dr David Garry

Stony Brook Medicine

Phone: 631-444-7650

Email: david.garry@stonybrookmedicine.edu

Results disclosure agreements

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