CHLORHEXIDINE GLUCONATE AND POVIDONE IODINE

July 12, 2023 updated by: öznur tiryaki, Sakarya University

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

102

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey
      • Sakarya, Turkey, 54050
        • Sakarya University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: CHLORHEXIDINE GLUCONATE GROUP
Section area is cleaned with preoperative application chlorhexidine gluconate
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
No Intervention: POVIDONE IODINE GROUP
Section area is cleaned with preoperative application povidone iodine
Experimental: CHLORHEXIDINE GLUCONATE SHOWER GROUP
Section area is cleaned with preoperative application chlorhexidine gluconate shower
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
To determine that cleaning the incision site with 2% CG solution (containing 70% alcohol) is more effective than PI in the wound healing process.
Time Frame: 4 months
To determine that using the Incision site evaluation form (ISEF). This form was used to evaluate erythema, warmth, oedema, discharge and wound opening. The score of form is between 0-3 for each item, and the total score is between 0-15. According to the form, a high score is interpreted as a poor recovery.
4 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Time Frame: 4 months
To determine that using the Incision site evaluation form (ISEF). This form was used to evaluate erythema, warmth, oedema, discharge and wound opening. The score of form is between 0-3 for each item, and the total score is between 0-15. According to the form, a high score is interpreted as a poor recovery.
4 months
To determine that cleaning the incision site with 2% CG solution (containing 70% alcohol) provides a higher level of postpartum comfort than PI
Time Frame: 4 months
The Postpartum Comfort Questionnaire (PPCQ) is a scale that evaluates the physical, psycho-spiritual and sociocultural comfort of mothers who had cesarean and normal births. Physical comfort is defined as psycho-spiritual comfort, the relationship between spirituality and mind, as physiological indicators that can contribute to the healing process, socio-cultural comfort, and relations with family and environment. There are positive and negative items in the five-point Likert-type scale, which consists of thirty-four items, with the lowest possible score being 34 and the highest score being 170. A higher score indicates a higher level of comfort. Comfort status was determined with this questionnaire.
4 months
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.
Time Frame: 4 months
The Postpartum Comfort Questionnaire (PPCQ) is a scale that evaluates the physical, psycho-spiritual and sociocultural comfort of mothers who had cesarean and normal births. Physical comfort is defined as psycho-spiritual comfort, the relationship between spirituality and mind, as physiological indicators that can contribute to the healing process, socio-cultural comfort, and relations with family and environment. There are positive and negative items in the five-point Likert-type scale, which consists of thirty-four items, with the lowest possible score being 34 and the highest score being 170. A higher score indicates a higher level of comfort. Comfort status was determined with this questionnaire.
4 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sakarya University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 1, 2020

Primary Completion (Actual)

February 1, 2021

Study Completion (Actual)

May 30, 2021

Study Registration Dates

First Submitted

July 3, 2023

First Submitted That Met QC Criteria

July 12, 2023

First Posted (Actual)

July 20, 2023

Study Record Updates

Last Update Posted (Actual)

July 20, 2023

Last Update Submitted That Met QC Criteria

July 12, 2023

Last Verified

July 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CHLORHEXIDINE

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

IPD Plan Description

After our study will be published, we will share our detail information about our study

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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