Please select the arm or intervention descriptions that belong to the clinical trial below.
Title: Antiseptic Skin Preparation for Preventing Surgical Site Infection at Cesarean Delivery: a Randomized Comparative Effectiveness Trial
Brief Summary: The investigators propose a randomized controlled clinical trial to determine the comparative effectiveness of chlorhexidine-alcohol and iodine-alcohol preoperative skin preparation for preventing surgical site infections at cesarean section. While estimates vary, surgical site infections complicate up to 5 - 10% of all cesarean sections and result in significant human suffering and excess health care costs. Interventions such as preoperative antibiotic prophylaxis reduce surgical site infections by 60%, but the rate of infection remains high. There is therefore a great need to identify and test other potential interventions to further reduce these infections.

The skin is a major source of pathogens that cause surgical site infection. Therefore, optimizing preoperative skin antisepsis has the potential to decrease postoperative surgical site infections. There is paucity of evidence to guide the choice of antiseptic for skin preparation at cesarean section. To date, only two underpowered trials have been published comparing two methods of preoperative skin preparation at cesarean section. A recent randomized trial in adults undergoing clean-contaminated mostly general surgical procedures demonstrated a 41% reduction in surgical site infection with the use of chlorhexidine-alcohol when compared to the more commonly used povidone-iodine. While it is plausible that findings from trials in other clean-contaminated surgical procedures may apply to cesarean sections, physiological changes in pregnancy, the peculiar dual microbial source for cesarean-related infections and the hormone-mediated immune-modulation in pregnancy make the validity of such extrapolation uncertain.

The study has the following specific aims:

Primary Aim: To test the hypothesis that preoperative chlorhexidine-alcohol skin preparation at cesarean section significantly reduces surgical site infections compared to iodine-alcohol.

Secondary Aim 1: To test the hypothesis that preoperative chlorhexidine-alcohol skin preparation at cesarean section significantly reduces bacterial contamination at the surgical site compared to iodine-alcohol.

Secondary Aim 2: To determine clinical outcomes and medical costs associated with cesarean-related infections and quantify potential cost savings attributable to use of chlorhexidine-alcohol for preoperative skin preparation at cesarean section.


Options:
A: Arm Label: Chlorhexidine - Isopropyl alcohol; Type: EXPERIMENTAL; Interventions: Drug: Chlorhexidine - Isopropyl alcohol | Arm Label: Povidone-Iodine Scrub and Paint; Type: EXPERIMENTAL; Interventions: Drug: Povidone-Iodine Scrub and Paint | Intervention Type: DRUG; Name: Chlorhexidine - Isopropyl alcohol; Assigned to Arm(s): Chlorhexidine - Isopropyl alcohol | Intervention Type: DRUG; Name: Povidone-Iodine Scrub and Paint; Assigned to Arm(s): Povidone-Iodine Scrub and Paint
B: Arm Label: Combination iodine and chlorhexidine; Type: ACTIVE_COMPARATOR; Interventions: Drug: Combination iodine and chlorhexidine | Arm Label: Chlorhexidine; Type: ACTIVE_COMPARATOR; Interventions: Drug: Chlorhexidine | Arm Label: Iodine povidone; Type: ACTIVE_COMPARATOR; Interventions: Drug: Iodine povidone | Intervention Type: DRUG; Name: Iodine povidone; Assigned to Arm(s): Iodine povidone | Intervention Type: DRUG; Name: Chlorhexidine; Assigned to Arm(s): Chlorhexidine | Intervention Type: DRUG; Name: Combination iodine and chlorhexidine; Assigned to Arm(s): Combination iodine and chlorhexidine
C: Arm Label: Povidone Iodine; Type: ACTIVE_COMPARATOR; Interventions: Procedure: Povidone Iodine | Arm Label: Chlorhexidine gluconate; Type: ACTIVE_COMPARATOR; Interventions: Procedure: Chlorhexidine gluconate | Intervention Type: PROCEDURE; Name: Povidone Iodine; Assigned to Arm(s): Povidone Iodine | Intervention Type: PROCEDURE; Name: Chlorhexidine gluconate; Assigned to Arm(s): Chlorhexidine gluconate
D: Arm Label: Iodine-alcohol; Type: ACTIVE_COMPARATOR; Interventions: Drug: Iodine-alcohol | Arm Label: Chlorhexidine-alcohol; Type: EXPERIMENTAL; Interventions: Drug: Chlorhexidine-alcohol | Intervention Type: DRUG; Name: Iodine-alcohol; Assigned to Arm(s): Iodine-alcohol | Intervention Type: DRUG; Name: Chlorhexidine-alcohol; Assigned to Arm(s): Chlorhexidine-alcohol

Answer: D