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There is no difference between using chlorhexidine-based antisepsis protocol versus povidone-iodine protocol in reduction of surgical site infection in women undergoing cesarean section.
The aim of this study is to examine the efficacy &safety of Chlorhexidine-based antisepsis protocol versus povidone- iodine protocol used as preoperative skin antisepsis for patients undergoing cesarean section in reduction of surgical site infection.Chlorhexidine is a chemical antiseptic. It is effective on both Gram-positive and Gram-negative bacteria, although it is less effective with some Gram-negative bacteria. It has both bactericidal and bacteriostatic mechanisms of action, the mechanism of action being membrane disruption.
Iodine is commonly used as an antiseptic agent clinically. Iodine is usually formulated as an iodophor, which consists of iodine combined with a carrier molecule. This formulation increases the solubility of iodine and provides a reservoir for sustained release. The most commonly used iodophor is povidone iodine which is a 10% iodophor solution that contains 1% available iodine. Iodine molecules penetrate microbial cell walls and cause oxidation of cysteine, iodination of amino acids and unsaturated fatty acids. This leads to reduced protein synthesis and bacterial cell wall damage.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| chlorhexidine _based antisepsis | Experimental | Including cases undergoing elective&non elective caesarean section.Patients will be were prepared similarly by three applications of 2%chlorhexidine solution time given between each application about 30 seconds followed by drying with a sterile towel and three applications of 70% alcohol after one minute The area scrubbed was from the xiphoid to the knee, reaching the midaxillary line laterally. In both groups, patients received preoperative prophylactic i.v antibiotics (cefotrixone 1 gm) one hour before skin incision. . |
|
| povidone_iodine based antisepsis | Active Comparator | Including cases undergoing elective&nonelective caesarean section.Patients will be scrubbed preoperative with an applicator that contain 10%povidone-iodine scrub aqueous solution(3 consecutive applications)followed by drying with sterile towel and 3 application of 70% alcohol after one minute The area scrubbed was from the xiphoid to the knee, reaching the midaxillary line laterally. In both groups, patients received preoperative prophylactic i.v antibiotics (cefotrixone 1 gm) one hour before skin incision |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Chlorhexidine | Drug |
| ||
| Povidone-Iodine |
| Measure | Description | Time Frame |
|---|---|---|
| Surgical site infection within one week after surgery | One week |
| Measure | Description | Time Frame |
|---|---|---|
| Surgical site infection within 30 days after surgery | in 30 days | |
| Long hospital stay | hospital admission for more than 5 days | 30 days |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| AMR YEHIA, MD, MRCOG | Contact | +201227900014 | am_helmy77@hotmail.com |
| Name | Affiliation | Role |
|---|---|---|
| AMR YEHIA, MD, MRCOG | Ain Shams Maternity Hospital | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ain Shams Maternity Hospital | Recruiting | Cairo | 11566 | Egypt |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 32580252 | Derived | Hadiati DR, Hakimi M, Nurdiati DS, Masuzawa Y, da Silva Lopes K, Ota E. Skin preparation for preventing infection following caesarean section. Cochrane Database Syst Rev. 2020 Jun 25;6(6):CD007462. doi: 10.1002/14651858.CD007462.pub5. |
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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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| ID | Term |
|---|---|
| D002710 | Chlorhexidine |
| D011206 | Povidone-Iodine |
| ID | Term |
|---|---|
| D001645 | Biguanides |
| D006146 | Guanidines |
| D000578 | Amidines |
| D009930 | Organic Chemicals |
| D007466 |
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|
|
| Hospital readmission |
readmission due to sepsis |
| 30 days |
| Febrile morbidity | an oral temperature of 38.0 degree Celsius)or more on any two of the first 10 days postpartum, exclusive of the first 24 hours | 10 days |
| D013568 |
| Pathological Conditions, Signs and Symptoms |
| Iodophors |
| D017613 | Iodine Compounds |
| D007287 | Inorganic Chemicals |
| D011145 | Polyvinyls |
| D014753 | Vinyl Compounds |
| D000475 | Alkenes |
| D006839 | Hydrocarbons, Acyclic |
| D006838 | Hydrocarbons |
| D011205 | Povidone |
| D011760 | Pyrrolidinones |
| D011759 | Pyrrolidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D010969 | Plastics |
| D011108 | Polymers |
| D046911 | Macromolecular Substances |
| D001697 | Biomedical and Dental Materials |
| D008420 | Manufactured Materials |
| D013676 | Technology, Industry, and Agriculture |