CHLORHEXIDINE GLUCONATE AND POVIDONE IODINE

Sakarya University

Status: Completed

Conditions: Evaluate to Effects of Two Antiseptic Products and Showering

Treatments: Other: incision side cleaning with antiseptic products

Study type: Interventional

Funder types: Other

Identifiers

NCT05953714

CHLORHEXIDINE

Details and patient eligibility

About

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.

Full 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.

Enrollment: 102 patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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102 participants in 3 patient groups

CHLORHEXIDINE GLUCONATE GROUP

Experimental group

Description:

Section area is cleaned with preoperative application chlorhexidine gluconate

Treatment:

Other: incision side cleaning with antiseptic products

POVIDONE IODINE GROUP

No Intervention group

Description:

Section area is cleaned with preoperative application povidone iodine

CHLORHEXIDINE GLUCONATE SHOWER GROUP

Experimental group

Description:

Section area is cleaned with preoperative application chlorhexidine gluconate shower

Treatment:

Other: incision side cleaning with antiseptic products