Evaluate to Effects of Two Antiseptic Products and ShoweringNCT05953714
CHLORHEXIDINE GLUCONATE AND POVIDONE IODINE
A study testing incision side cleaning with antiseptic products in people with Evaluate to Effects of Two Antiseptic Products and Showering, run by Sakarya University at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Evaluate to Effects of Two Antiseptic Products and Showering
- What is being tested?
- incision side cleaning with antiseptic products
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 102 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Dec 2020to 30 May 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- hospitalized with a planned cesarean section scheduled between the study dates
- volunteer woman
Who cannot join
- participants who dont meet the inclusion criteria
- labor
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Being tested
- incision side cleaning with antiseptic products
- Keywords
- Cesarean section, surgical site infection, povidone iodine, chlorhexidine gluconate, patient comfort, healing process
- Medical subject headings
- Surgical Wound Infection
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
incision side cleaning with antiseptic productsOther
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
| Study group | Role | What they receive |
|---|---|---|
| CHLORHEXIDINE GLUCONATE GROUP | Experimental | Section area is cleaned with preoperative application chlorhexidine gluconate Receives: Other: incision side cleaning with antiseptic products |
| POVIDONE IODINE GROUP | No intervention | Section area is cleaned with preoperative application povidone iodine |
| CHLORHEXIDINE GLUCONATE SHOWER GROUP | Experimental | Section area is cleaned with preoperative application chlorhexidine gluconate shower Receives: Other: incision side cleaning with antiseptic products |
What is being measured
The primary outcome is the main question the study is designed to answer.
To determine that cleaning the incision site with 2% CG solution (containing 70% alcohol) is more effective than PI in the wound healing process.
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.
Measured: 4 months
Secondary outcomes (3)
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.
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.
Measured: 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
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.
Measured: 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.
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.
Measured: 4 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jul 2023
- Study start1 Dec 2020
- Primary completion1 Feb 2021
- Study completion30 May 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (28)Papers the sponsor has linked to this study.
- Other trials for Evaluate to Effects of Two Antiseptic Products and ShoweringStudies of the same condition, open and under way.
- More trials run by Sakarya UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 102 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sakarya University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, öznur tiryaki, Sakarya University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05953714
- Sponsor's protocol ID
- CHLORHEXIDINE
- Status last verified
- Jul 2023
- First submitted
- 3 Jul 2023
- Last updated
- 20 Jul 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: After our study will be published, we will share our detail information about our study
Publications
Lai YL, Hung CH, Stocker J, Chan TF, Liu Y. Postpartum fatigue, baby-care activities, and maternal-infant attachment of vaginal and cesarean births following rooming-in. Appl Nurs Res. 2015 May;28(2):116-20. doi: 10.1016/j.apnr.2014.08.002. Epub 2014 Oct 23.
PubMed 25468429Villers MS. Reducing Cesarean Delivery Surgical Site Complications. Obstet Gynecol Clin North Am. 2020 Sep;47(3):429-437. doi: 10.1016/j.ogc.2020.04.006. Epub 2020 Jun 6.
PubMed 32762928Corcoran S, Jackson V, Coulter-Smith S, Loughrey J, McKenna P, Cafferkey M. Surgical site infection after cesarean section: implementing 3 changes to improve the quality of patient care. Am J Infect Control. 2013 Dec;41(12):1258-63. doi: 10.1016/j.ajic.2013.04.020. Epub 2013 Aug 9.
PubMed 23938001Charehbili A, Koek MBG, de Mol van Otterloo JCA, Bronkhorst MWGA, van der Zwaal P, Thomassen B, Waasdorp EJ, Govaert JA, Bosman A, van den Bremer J, Ploeg AJ, Putter H, Meijs AP, van de Velde CJH, van Gijn W, Swijnenburg RJ. Cluster-randomized crossover trial of chlorhexidine-alcohol versus iodine-alcohol for prevention of surgical-site infection (SKINFECT trial). BJS Open. 2019 May 20;3(5):617-622. doi: 10.1002/bjs5.50177. eCollection 2019 Oct.
PubMed 31592513Burke C, Allen R. Complications of Cesarean Birth: Clinical Recommendations for Prevention and Management. MCN Am J Matern Child Nurs. 2020 Mar/Apr;45(2):92-99. doi: 10.1097/NMC.0000000000000598.
PubMed 31804227Money L, Eyer M, Duncan K. Creating a Surgical Site Infection Prevention Bundle for Patients Undergoing Cesarean Delivery: 1.6 www.aornjournal.org/content/cme. AORN J. 2018 Oct;108(4):372-383. doi: 10.1002/aorn.12371.
PubMed 30265380Kawakita T, Landy HJ. Surgical site infections after cesarean delivery: epidemiology, prevention and treatment. Matern Health Neonatol Perinatol. 2017 Jul 5;3:12. doi: 10.1186/s40748-017-0051-3. eCollection 2017.
PubMed 28690864Huang H, Li G, Wang H, He M. Optimal skin antiseptic agents for prevention of surgical site infection in cesarean section: a meta-analysis with trial sequential analysis. J Matern Fetal Neonatal Med. 2018 Dec;31(24):3267-3274. doi: 10.1080/14767058.2017.1368481. Epub 2017 Aug 30.
PubMed 28817989Stone J, Bianco A, Monro J, Overybey JR, Cadet J, Choi KH, Pena J, Robles BN, Mella MT, Matthews KC, Factor SH. Study To Reduce Infection Prior to Elective Cesarean Deliveries (STRIPES): a randomized clinical trial of chlorhexidine. Am J Obstet Gynecol. 2020 Jul;223(1):113.e1-113.e11. doi: 10.1016/j.ajog.2020.05.021. Epub 2020 May 12.
PubMed 32407786Leblebicioglu H, Erben N, Rosenthal VD, Sener A, Uzun C, Senol G, Ersoz G, Demirdal T, Duygu F, Willke A, Sirmatel F, Oztoprak N, Koksal I, Oncul O, Gurbuz Y, Guclu E, Turgut H, Yalcin AN, Ozdemir D, Kendirli T, Aslan T, Esen S, Ulger F, Dilek A, Yilmaz H, Sunbul M, Ozgunes I, Usluer G, Otkun M, Kaya A, Kuyucu N, Kaya Z, Meric M, Azak E, Yylmaz G, Kaya S, Ulusoy H, Haznedaroglu T, Gorenek L, Acar A, Tutuncu E, Karabay O, Kaya G, Sacar S, Sungurtekin H, Ugurcan D, Turhan O, Kaya S, Gumus E, Dursun O, Geyik MF, Sahin A, Erdogan S, Ince E, Karbuz A, Ciftci E, Tasyapar N, Gunes M. Surgical site infection rates in 16 cities in Turkey: findings of the International Nosocomial Infection Control Consortium (INICC). Am J Infect Control. 2015 Jan;43(1):48-52. doi: 10.1016/j.ajic.2014.09.017.
PubMed 25564124Ruhstaller K, Downes KL, Chandrasekaran S, Srinivas S, Durnwald C. Prophylactic Wound Vacuum Therapy after Cesarean Section to Prevent Wound Complications in the Obese Population: A Randomized Controlled Trial (the ProVac Study). Am J Perinatol. 2017 Sep;34(11):1125-1130. doi: 10.1055/s-0037-1604161. Epub 2017 Jul 13.
PubMed 28704847Hadiati DR, Hakimi M, Nurdiati DS, da Silva Lopes K, Ota E. Skin preparation for preventing infection following caesarean section. Cochrane Database Syst Rev. 2018 Oct 22;10(10):CD007462. doi: 10.1002/14651858.CD007462.pub4.
PubMed 30346040Ngai IM, Van Arsdale A, Govindappagari S, Judge NE, Neto NK, Bernstein J, Bernstein PS, Garry DJ. Skin Preparation for Prevention of Surgical Site Infection After Cesarean Delivery: A Randomized Controlled Trial. Obstet Gynecol. 2015 Dec;126(6):1251-1257. doi: 10.1097/AOG.0000000000001118.
PubMed 26551196Kunkle CM, Marchan J, Safadi S, Whitman S, Chmait RH. Chlorhexidine gluconate versus povidone iodine at cesarean delivery: a randomized controlled trial. J Matern Fetal Neonatal Med. 2015 Mar;28(5):573-7. doi: 10.3109/14767058.2014.926884. Epub 2014 Jun 18.
PubMed 24849000Sahin S, Sinan O. Investigation of mothers' postpartum breastfeeding and comfort conditions. Health Care Women Int. 2021;42(4-6):913-924. doi: 10.1080/07399332.2021.1883022. Epub 2021 Mar 8.
PubMed 33683176
Study at a glance
From the registry record, last updated by the sponsor on 20 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- THE EFFECT OF USING CHLORHEXIDINE GLUCONATE AND POVIDONE IODINE SOLUTION ON THE HEALING PROCESS BEFORE A CESAREAN SECTION
- ClinicalTrials.gov ID
- NCT05953714
- Acronym / sponsor ID
- CHLORHEXIDINE
- Keywords
- Cesarean section, surgical site infection, povidone iodine, chlorhexidine gluconate, patient comfort, healing process
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 102 participants (actual)
- Lead sponsor
- Sakarya UniversityUniversity, hospital or other
- Study start
- 1 Dec 2020 (actual)
- Primary completion
- 1 Feb 2021 (actual)
- Study completion
- 30 May 2021 (actual)
- First posted
- 20 Jul 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
- 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.
| Arm | Type | Receives |
|---|---|---|
| CHLORHEXIDINE GLUCONATE GROUP | Experimental | Other: incision side cleaning with antiseptic productsSection area is cleaned with preoperative application chlorhexidine gluconate |
| POVIDONE IODINE GROUP | No intervention | –Section area is cleaned with preoperative application povidone iodine |
| CHLORHEXIDINE GLUCONATE SHOWER GROUP | Experimental | Other: incision side cleaning with antiseptic productsSection area is cleaned with preoperative application chlorhexidine gluconate shower |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- hospitalized with a planned cesarean section scheduled between the study dates
- volunteer woman
Key exclusion criteria (2 listed)
- participants who dont meet the inclusion criteria
- labor
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| incision side cleaning with antiseptic productsA 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 | Other | CHLORHEXIDINE GLUCONATE GROUP, CHLORHEXIDINE GLUCONATE SHOWER GROUP |
Primary outcome
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.
3 secondary outcomes
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 cleaning the incision site with 2% CG solution (containing 70% alcohol) provides a higher level of postpartum comfort than PI
Time frame: 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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jul 2023.
- Background: PubMed 25468429Lai YL, Hung CH, Stocker J, Chan TF, Liu Y. Postpartum fatigue, baby-care activities, and maternal-infant attachment of vaginal and cesarean births following rooming-in. Appl Nurs Res. 2015 May;28(2):116-20. doi: 10.1016/j.apnr.2014.08.002. Epub 2014 Oct 23.
- Results publication: PubMed 32762928Villers MS. Reducing Cesarean Delivery Surgical Site Complications. Obstet Gynecol Clin North Am. 2020 Sep;47(3):429-437. doi: 10.1016/j.ogc.2020.04.006. Epub 2020 Jun 6.
- Results publication: PubMed 23938001Corcoran S, Jackson V, Coulter-Smith S, Loughrey J, McKenna P, Cafferkey M. Surgical site infection after cesarean section: implementing 3 changes to improve the quality of patient care. Am J Infect Control. 2013 Dec;41(12):1258-63. doi: 10.1016/j.ajic.2013.04.020. Epub 2013 Aug 9.
- Results publication: PubMed 31592513Charehbili A, Koek MBG, de Mol van Otterloo JCA, Bronkhorst MWGA, van der Zwaal P, Thomassen B, Waasdorp EJ, Govaert JA, Bosman A, van den Bremer J, Ploeg AJ, Putter H, Meijs AP, van de Velde CJH, van Gijn W, Swijnenburg RJ. Cluster-randomized crossover trial of chlorhexidine-alcohol versus iodine-alcohol for prevention of surgical-site infection (SKINFECT trial). BJS Open. 2019 May 20;3(5):617-622. doi: 10.1002/bjs5.50177. eCollection 2019 Oct.
- Results publication: PubMed 31804227Burke C, Allen R. Complications of Cesarean Birth: Clinical Recommendations for Prevention and Management. MCN Am J Matern Child Nurs. 2020 Mar/Apr;45(2):92-99. doi: 10.1097/NMC.0000000000000598.
- Results publication: PubMed 30265380Money L, Eyer M, Duncan K. Creating a Surgical Site Infection Prevention Bundle for Patients Undergoing Cesarean Delivery: 1.6 www.aornjournal.org/content/cme. AORN J. 2018 Oct;108(4):372-383. doi: 10.1002/aorn.12371.
- Results publication: PubMed 28690864Kawakita T, Landy HJ. Surgical site infections after cesarean delivery: epidemiology, prevention and treatment. Matern Health Neonatol Perinatol. 2017 Jul 5;3:12. doi: 10.1186/s40748-017-0051-3. eCollection 2017.
- Results publication: PubMed 28817989Huang H, Li G, Wang H, He M. Optimal skin antiseptic agents for prevention of surgical site infection in cesarean section: a meta-analysis with trial sequential analysis. J Matern Fetal Neonatal Med. 2018 Dec;31(24):3267-3274. doi: 10.1080/14767058.2017.1368481. Epub 2017 Aug 30.
- Results publication: PubMed 32407786Stone J, Bianco A, Monro J, Overybey JR, Cadet J, Choi KH, Pena J, Robles BN, Mella MT, Matthews KC, Factor SH. Study To Reduce Infection Prior to Elective Cesarean Deliveries (STRIPES): a randomized clinical trial of chlorhexidine. Am J Obstet Gynecol. 2020 Jul;223(1):113.e1-113.e11. doi: 10.1016/j.ajog.2020.05.021. Epub 2020 May 12.
- Results publication: PubMed 25564124Leblebicioglu H, Erben N, Rosenthal VD, Sener A, Uzun C, Senol G, Ersoz G, Demirdal T, Duygu F, Willke A, Sirmatel F, Oztoprak N, Koksal I, Oncul O, Gurbuz Y, Guclu E, Turgut H, Yalcin AN, Ozdemir D, Kendirli T, Aslan T, Esen S, Ulger F, Dilek A, Yilmaz H, Sunbul M, Ozgunes I, Usluer G, Otkun M, Kaya A, Kuyucu N, Kaya Z, Meric M, Azak E, Yylmaz G, Kaya S, Ulusoy H, Haznedaroglu T, Gorenek L, Acar A, Tutuncu E, Karabay O, Kaya G, Sacar S, Sungurtekin H, Ugurcan D, Turhan O, Kaya S, Gumus E, Dursun O, Geyik MF, Sahin A, Erdogan S, Ince E, Karbuz A, Ciftci E, Tasyapar N, Gunes M. Surgical site infection rates in 16 cities in Turkey: findings of the International Nosocomial Infection Control Consortium (INICC). Am J Infect Control. 2015 Jan;43(1):48-52. doi: 10.1016/j.ajic.2014.09.017.
- Results publication: PubMed 28704847Ruhstaller K, Downes KL, Chandrasekaran S, Srinivas S, Durnwald C. Prophylactic Wound Vacuum Therapy after Cesarean Section to Prevent Wound Complications in the Obese Population: A Randomized Controlled Trial (the ProVac Study). Am J Perinatol. 2017 Sep;34(11):1125-1130. doi: 10.1055/s-0037-1604161. Epub 2017 Jul 13.
- Results publication: PubMed 30346040Hadiati DR, Hakimi M, Nurdiati DS, da Silva Lopes K, Ota E. Skin preparation for preventing infection following caesarean section. Cochrane Database Syst Rev. 2018 Oct 22;10(10):CD007462. doi: 10.1002/14651858.CD007462.pub4.
- Centers for Disease Control and Prevention. (2021). Births: Final data for 2019Link provided by the sponsor.
- Turkish Society of Gynecology and Obstetrics, Ministry of HealthLink provided by the sponsor.
- Individual participant dataSharing planned: Undecided. After our study will be published, we will share our detail information about our study
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing incision side cleaning with antiseptic products in people with Evaluate to Effects of Two Antiseptic Products and Showering, run by Sakarya University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Jul 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome 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. (time frame: 4 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05953714, which also lists 28 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Jul 2023.