NCT05953714

CHLORHEXIDINE GLUCONATE AND POVIDONE IODINE

THE EFFECT OF USING CHLORHEXIDINE GLUCONATE AND POVIDONE IODINE SOLUTION ON THE HEALING PROCESS BEFORE A CESAREAN SECTION

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 102 (actual)
• Sponsor: Sakarya University · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The study was planned to evaluate the effects of two most commonly used antiseptic products and showering on the healing process, such as wound healing and postoperative maternal comfort in cesarean section. A randomized controlled trial included 102 pregnant women from February and May of 2021. They were randomly divided into povidone iodine (PI) group (A) chlorhexidine gluconate (CG) group (B) and CG shower (C) operated by two Gynecology and Obstetrics physician. Data from the in house blinding study to avoid bias and follow-up of the women was done for 7 day duration following postnatal to assess postoperative for comfort, pain, wound complications.

Detailed description

Purpose and type of research This study was designed as a randomized controlled trial to examine the effect of preoperative use of CG and PI on the postoperative healing process and maternal postpartum comfort. Hypothesis H1: Cleaning the incision area with a 2% CG solution (containing 70% alcohol) is more effective in the wound healing process than PI. H2: Taking a shower with a 2% CG solution (containing 70% alcohol) 6 hours before, and cleaning the incision area, is more effective in the wound healing process than PI. H3: Cleaning the incision area with a 2% CG solution (containing 70% alcohol) produces a higher postpartum comfort level than PI. H4: Taking a shower 6 hours before with a 2% CG solution (containing 70% alcohol), and cleaning the incision area, produces a higher postpartum comfort level than PI. Variables in the study include dependent variables: signs of the wound healing process at the incision site (erythema, edema, ecchymosis, discharge, wound dehiscence and pain), and independent variables: a 2% CG (70% alcohol) solution and the application of PI. Participants This research was carried out in a Turkish research hospital clinic between February and May of 2021. The study sample consisted of all pregnant women (n = 504) who were hospitalized with a planned cesarean section scheduled between the study dates. The study sample consisted of 102 pregnant women who met the inclusion criteria and who agreed to participate in the study after informed consent was obtained. They were randomly divided into groups. The study sample consisted of three groups: 1) those cleaned with povidone-iodine (PI) before the surgical incision, 2) those cleaned with chlorhexidine gluconate (CG) before the surgical incision and 3) those showering with CG six hours before the surgical incision and cleaned with CG before the surgical incision.

Conditions

• Evaluate to Effects of Two Antiseptic Products and Showering

Interventions

Type	Name	Description
OTHER	incision side cleaning with antiseptic products	A pilot study was conducted with six pregnant women to clarify the use of the data collection tools and the implementation plan during the study process. After that, the data collection forms were finalized. In the 6 operating room, two different solutions (PI and CG) were applied, according to the preference of the physician, to clean the surgical field. The study was carried out by adding a CG shower application to the physician's preferred solution (for a total of 3 groups). Pregnant women who were admitted to the obstetrics clinic were informed about the purpose, scope, duration, and method of the study by one of the researchers. Follow-up of the women was done for 7 day duration following postnatal to assess postoperative for comfort, pain, wound complications by the nurse researcher. At discharge, cultures were taken from the abdominal wounds of the participants

Timeline

• Start date: 2020-12-01
• Primary completion: 2021-02-01
• Completion: 2021-05-30
• First posted: 2023-07-20
• Last updated: 2023-07-20

Locations

1 site across 1 country: Turkey (Türkiye)