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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| CHLORHEXIDINE GLUCONATE GROUP | Experimental | Section 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 | Section area is cleaned with preoperative application chlorhexidine gluconate shower |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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 |
| 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. | 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 |
| 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. | 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. |
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Inclusion Criteria:
Exclusion Criteria:
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.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Sakarya University | Sakarya | 54050 | Turkey (Türkiye) |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 25468429 | Background | 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. | |
| 32762928 | Result | Villers 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. |
| Label | URL |
|---|---|
| Centers for Disease Control and Prevention. (2021). Births: Final data for 2019 | View source |
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After our study will be published, we will share our detail information about our study
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| ID | Term |
|---|---|
| D013530 | Surgical Wound Infection |
| ID | Term |
|---|---|
| D014946 | Wound Infection |
| D007239 | Infections |
| D011183 | Postoperative Complications |
| D010335 | Pathologic Processes |
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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.
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The inclusion criteria included the absence of systemic and chronic disease (thyroid disease, gestational diabetes, gestational hypertension or allergy), no history of previous abdominal surgery, a newborn baby follow-up with no health problems that would hinder the breastfeeding process, 37 gestational weeks of pregnancy and above, pregnant women with a low-risk pregnancy, those with a body mass index between 20 and 30 who were at least a primary school graduate, and who were between 19 to 40 years of age.
|
| 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. | 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. | 4 months |
| 23938001 | Result | Corcoran 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. |
| 31592513 | Result | Charehbili 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. |
| 31804227 | Result | Burke 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. |
| 30265380 | Result | Money 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. |
| 28690864 | Result | Kawakita 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. |
| 28817989 | Result | Huang 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. |
| 32407786 | Result | Stone 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. |
| 25564124 | Result | Leblebicioglu 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. |
| 28704847 | Result | Ruhstaller 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. |
| 30346040 | Result | Hadiati 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. |
| 26551196 | Result | Ngai 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. |
| 24849000 | Result | Kunkle 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. |
| 33683176 | Result | Sahin 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. |
| 32036820 | Result | Zengin H, Bafali IO, Caka SY, Tiryaki O, Cinar N. Childbirth and Postpartum Period Fear and the Related Factors in Pregnancy. J Coll Physicians Surg Pak. 2020 Feb;30(2):144-148. doi: 10.29271/jcpsp.2020.02.144. |
| 1015603 | Result | Revill SI, Robinson JO, Rosen M, Hogg MI. The reliability of a linear analogue for evaluating pain. Anaesthesia. 1976 Nov;31(9):1191-8. doi: 10.1111/j.1365-2044.1976.tb11971.x. |
| 25165836 | Result | Brown CR, Dodds L, Legge A, Bryanton J, Semenic S. Factors influencing the reasons why mothers stop breastfeeding. Can J Public Health. 2014 May 9;105(3):e179-85. doi: 10.17269/cjph.105.4244. |
| 23622749 | Result | Edmiston CE Jr, Bruden B, Rucinski MC, Henen C, Graham MB, Lewis BL. Reducing the risk of surgical site infections: does chlorhexidine gluconate provide a risk reduction benefit? Am J Infect Control. 2013 May;41(5 Suppl):S49-55. doi: 10.1016/j.ajic.2012.10.030. |
| 23114192 | Result | Kapadia BH, Johnson AJ, Daley JA, Issa K, Mont MA. Pre-admission cutaneous chlorhexidine preparation reduces surgical site infections in total hip arthroplasty. J Arthroplasty. 2013 Mar;28(3):490-3. doi: 10.1016/j.arth.2012.07.015. Epub 2012 Oct 29. |
| 20880006 | Result | Jakobsson J, Perlkvist A, Wann-Hansson C. Searching for evidence regarding using preoperative disinfection showers to prevent surgical site infections: a systematic review. Worldviews Evid Based Nurs. 2011 Sep;8(3):143-52. doi: 10.1111/j.1741-6787.2010.00201.x. Epub 2010 Sep 28. |
| 22889522 | Result | Karki S, Cheng AC. Impact of non-rinse skin cleansing with chlorhexidine gluconate on prevention of healthcare-associated infections and colonization with multi-resistant organisms: a systematic review. J Hosp Infect. 2012 Oct;82(2):71-84. doi: 10.1016/j.jhin.2012.07.005. Epub 2012 Aug 11. |
| 32599228 | Result | Barreto R, Barrois B, Lambert J, Malhotra-Kumar S, Santos-Fernandes V, Monstrey S. Addressing the challenges in antisepsis: focus on povidone iodine. Int J Antimicrob Agents. 2020 Sep;56(3):106064. doi: 10.1016/j.ijantimicag.2020.106064. Epub 2020 Jun 26. |
| 30016540 | Result | Haas DM, Morgan S, Contreras K, Enders S. Vaginal preparation with antiseptic solution before cesarean section for preventing postoperative infections. Cochrane Database Syst Rev. 2018 Jul 17;7(7):CD007892. doi: 10.1002/14651858.CD007892.pub6. |
| 23543526 | Result | Dumville JC, McFarlane E, Edwards P, Lipp A, Holmes A. Preoperative skin antiseptics for preventing surgical wound infections after clean surgery. Cochrane Database Syst Rev. 2013 Mar 28;(3):CD003949. doi: 10.1002/14651858.CD003949.pub3. |
| 26844840 | Result | Tuuli MG, Liu J, Stout MJ, Martin S, Cahill AG, Odibo AO, Colditz GA, Macones GA. A Randomized Trial Comparing Skin Antiseptic Agents at Cesarean Delivery. N Engl J Med. 2016 Feb 18;374(7):647-55. doi: 10.1056/NEJMoa1511048. Epub 2016 Feb 4. |
| 22722008 | Result | Chlebicki MP, Safdar N, O'Horo JC, Maki DG. Preoperative chlorhexidine shower or bath for prevention of surgical site infection: a meta-analysis. Am J Infect Control. 2013 Feb;41(2):167-73. doi: 10.1016/j.ajic.2012.02.014. Epub 2012 Jun 19. |
| 18842327 | Result | Kasai KE, Nomura RM, Benute GR, de Lucia MC, Zugaib M. Women's opinions about mode of birth in Brazil: a qualitative study in a public teaching hospital. Midwifery. 2010 Jun;26(3):319-26. doi: 10.1016/j.midw.2008.08.001. Epub 2008 Oct 7. |
| Turkish Society of Gynecology and Obstetrics, Ministry of Health | View source |
| D013568 |
| Pathological Conditions, Signs and Symptoms |