Clinical trial NCT05953714: CHLORHEXIDINE GLUCONATE AND POVIDONE IODINE
Official title: THE EFFECT OF USING CHLORHEXIDINE GLUCONATE AND POVIDONE IODINE SOLUTION ON THE HEALING PROCESS BEFORE A CESAREAN SECTION
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Evaluate to Effects of Two Antiseptic Products and Showering
Keywords: Cesarean section
surgical site infection
povidone iodine
chlorhexidine gluconate
patient comfort
healing process
Lead sponsor: Sakarya University
Sponsor class: OTHER
First posted: 2023-07-20
Enrollment: 102
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: They were randomly divided into povidone iodine (PI) group (A) clorhexidine 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.
Primary purpose: SUPPORTIVE_CARE

Brief 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.

Eligibility criteria: Inclusion Criteria:

* hospitalized with a planned cesarean section scheduled between the study dates
* volunteer woman

Exclusion Criteria:

* participants who dont meet the inclusion criteria
* labor

Primary outcomes:
measure: To determine that cleaning the incision site with 2% CG solution (containing 70% alcohol) is more effective than PI in the wound healing process.
timeFrame: 4 months
Secondary outcomes:
measure: To determine that taking a shower with 2% CG solution (containing 70% alcohol) 6 hours before and cleaning the incision site is more effective than PI in the wound healing process.
timeFrame: 4 months
measure: To determine that cleaning the incision site with 2% CG solution (containing 70% alcohol) provides a higher level of postpartum comfort than PI
timeFrame: 4 months
measure: To determine that showering with 2% CG solution (containing 70% alcohol) 6 hours ago and cleaning the incision area provides a higher level of postpartum comfort compared to PI.
timeFrame: 4 months
Other outcomes:
Locations:
city: Sakarya
country: Turkey
facility: Sakarya University
Study officials:
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