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Completed

NCT Number: NCT05953714

CHLORHEXIDINE GLUCONATE AND POVIDONE IODINE

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.

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Key information

Conditions

Evaluate to Effects of Two Antiseptic Products and Showering Infections Pathologic Processes Pathological Conditions, Signs and Symptoms Postoperative Complications Surgical Wound Infection Wound Infection

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Sakarya University

Sakarya, 54050, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

incision side cleaning with antiseptic products

Other

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

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

  2. 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.

  3. 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.

Sponsors and collaborators

Lead sponsor

Sakarya University

Other

Registry information

Official study title

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

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Jul 20, 2023
Registry last updated
Jul 20, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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