Surgical Site Infection Clinical Trial
Official title:
A Randomized Control Trial of Chlorhexidine Gluconate Aqueous Solution vs Chlorhexidine Gluconate With Isopropyl Alcohol Skin Preparations for Prevention of Cesarean Section Wound Infections
This will be a single-center randomized control trial comparing the efficacy of two different formulations of Chlorhexidine surgical skin preparation in preventing cesarean section wound infections. Participants will be randomized to either 4% Chlorhexidine Gluconate aqueous solution (CHG) or 2% Chlorhexidine with isopropyl alcohol (CHG-IPA) 70% to examine the risk of infectious morbidity in those undergoing cesarean delivery. There will also be a cost-effectiveness analysis of the two preoperative skin preparations.
Status | Recruiting |
Enrollment | 1470 |
Est. completion date | June 1, 2025 |
Est. primary completion date | October 31, 2024 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Female |
Age group | 18 Years to 50 Years |
Eligibility | Inclusion Criteria: - Women undergoing cesarean delivery at Magee Women's Hospital Exclusion Criteria: - Inability to obtain consent (language barrier, emergency cesarean section etc.) - Allergy to chlorhexidine or alcohol - Chorioamnionitis - Emergency cesareans where cannot wait for chlorhexidine alcohol to dry - bowel injury at time of cesarean section - Women who are delivered at another institution and are transferred postpartum to Magees Women's Hospital |
Country | Name | City | State |
---|---|---|---|
United States | University of Pittsburgh | Pittsburgh | Pennsylvania |
Lead Sponsor | Collaborator |
---|---|
Yaneve Fonge |
United States,
Caughey AB, Wood SL, Macones GA, Wrench IJ, Huang J, Norman M, Pettersson K, Fawcett WJ, Shalabi MM, Metcalfe A, Gramlich L, Nelson G, Wilson RD. Guidelines for intraoperative care in cesarean delivery: Enhanced Recovery After Surgery Society Recommendations (Part 2). Am J Obstet Gynecol. 2018 Dec;219(6):533-544. doi: 10.1016/j.ajog.2018.08.006. Epub 2018 Aug 15. — View Citation
Costantine MM, Rahman M, Ghulmiyah L, Byers BD, Longo M, Wen T, Hankins GD, Saade GR. Timing of perioperative antibiotics for cesarean delivery: a metaanalysis. Am J Obstet Gynecol. 2008 Sep;199(3):301.e1-6. doi: 10.1016/j.ajog.2008.06.077. — View Citation
Darouiche RO, Wall MJ Jr, Itani KM, Otterson MF, Webb AL, Carrick MM, Miller HJ, Awad SS, Crosby CT, Mosier MC, Alsharif A, Berger DH. Chlorhexidine-Alcohol versus Povidone-Iodine for Surgical-Site Antisepsis. N Engl J Med. 2010 Jan 7;362(1):18-26. doi: 10.1056/NEJMoa0810988. — View Citation
Dumville JC, McFarlane E, Edwards P, Lipp A, Holmes A, Liu Z. Preoperative skin antiseptics for preventing surgical wound infections after clean surgery. Cochrane Database Syst Rev. 2015 Apr 21;2015(4):CD003949. doi: 10.1002/14651858.CD003949.pub4. — View Citation
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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. — View Citation
Levin I, Amer-Alshiek J, Avni A, Lessing JB, Satel A, Almog B. Chlorhexidine and alcohol versus povidone-iodine for antisepsis in gynecological surgery. J Womens Health (Larchmt). 2011 Mar;20(3):321-4. doi: 10.1089/jwh.2010.2391. Epub 2011 Feb 16. — View Citation
Maiwald M, Chan ES. Pitfalls in evidence assessment: the case of chlorhexidine and alcohol in skin antisepsis. J Antimicrob Chemother. 2014 Aug;69(8):2017-21. doi: 10.1093/jac/dku121. Epub 2014 Apr 28. — View Citation
Merkow RP, Ju MH, Chung JW, Hall BL, Cohen ME, Williams MV, Tsai TC, Ko CY, Bilimoria KY. Underlying reasons associated with hospital readmission following surgery in the United States. JAMA. 2015 Feb 3;313(5):483-95. doi: 10.1001/jama.2014.18614. — View Citation
Saeed KB, Greene RA, Corcoran P, O'Neill SM. Incidence of surgical site infection following caesarean section: a systematic review and meta-analysis protocol. BMJ Open. 2017 Jan 11;7(1):e013037. doi: 10.1136/bmjopen-2016-013037. — View Citation
Springel EH, Wang XY, Sarfoh VM, Stetzer BP, Weight SA, Mercer BM. A randomized open-label controlled trial of chlorhexidine-alcohol vs povidone-iodine for cesarean antisepsis: the CAPICA trial. Am J Obstet Gynecol. 2017 Oct;217(4):463.e1-463.e8. doi: 10.1016/j.ajog.2017.05.060. Epub 2017 Jun 7. — View Citation
Zimlichman E, Henderson D, Tamir O, Franz C, Song P, Yamin CK, Keohane C, Denham CR, Bates DW. Health care-associated infections: a meta-analysis of costs and financial impact on the US health care system. JAMA Intern Med. 2013 Dec 9-23;173(22):2039-46. doi: 10.1001/jamainternmed.2013.9763. — View Citation
Zuarez-Easton S, Zafran N, Garmi G, Salim R. Postcesarean wound infection: prevalence, impact, prevention, and management challenges. Int J Womens Health. 2017 Feb 17;9:81-88. doi: 10.2147/IJWH.S98876. eCollection 2017. — View Citation
* Note: There are 13 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Number of Participants with Surgical site Infection | Superficial or deep surgical-site infection within 30 days after cesarean delivery, on the basis of the National Healthcare Safety Network definitions of the Centers for Disease Control and Prevention. | Within 30 days post cesarean | |
Secondary | Number of Participants With Endometritis | Within 30 days post cesarean | ||
Secondary | Number of Participants with intrabdominal/pelvic abscess | Within 90 days post cesarean | ||
Secondary | Number of Participants with necrotizing fasciitis | Within 90 days post cesarean | ||
Secondary | Number of Participants with sepsis | With wound/uterine infection as the source | Within 90 days post cesarean | |
Secondary | Length of Hospital Stay | Within 90 days post cesarean | ||
Secondary | Number of Participants With Re-admissions or Office Visits for Wound-related Problems | Within 90 days post cesarean | ||
Secondary | Number of Participants with ICU admission for wound infectious complications | Within 90 days post cesarean | ||
Secondary | Number of Participants with Need for wound opening, exploration, or washout in the operating room | Within 90 days post cesarean | ||
Secondary | Number of Participants who needed wound vacuum | Within 90 days post cesarean | ||
Secondary | Number of Participants who needed home health | Within 90 days post cesarean | ||
Secondary | Number of patients who needed antibiotics | will also collect route of antibiotic administration and duration of treatment to assist with cost analysis | Within 90 days post cesarean | |
Secondary | Number of doses of antibiotic treatment | for wound infection complications | Within 90 days post cesarean | |
Secondary | Antibiotic regimens (medication names) used to treat infection | for wound infection complications | Within 90 days post cesarean | |
Secondary | Number of participants with positive culture from wound | Within 90 days post cesarean | ||
Secondary | The type of bacterial species isolated from wound infection cultures | Within 90 days post cesarean | ||
Secondary | Number of participants with hematoma | Within 90 days post cesarean | ||
Secondary | Number of participants with seroma | Within 30 days post cesarean | ||
Secondary | Number of Participants With Skin Irritation | within 48 hours from delivery | ||
Secondary | Number of Participants With Allergic Reaction | within 48 hours from delivery | ||
Secondary | Cost Savings | costs (dollars) associated with a hospital stay, office visits and re-admissions for infection-related complications, ICU admission for infectious complications, wound exploration or washout in the operating room, wound vacuum use, home health, antibiotic prescriptions, and duration of treatment will be collected and used to calculate the cost of wound infection management. The cost difference between groups will be calculated to estimate cost savings. | Within 90 days post cesarean |
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