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Postpartum infection if a major cause of maternal morbidity and mortality and surgical site infections are some of the common complications following cesarean section. This study aims to determine the effect of Steri3X on the incidence of cesarean section SSI at Regional One Hospital.
Postpartum infection is a major cause of maternal morbidity and prolonged hospitalization, and places a large burden on the healthcare system with an additional cost of $3,700 (Olsen et al., 2010). Surgical site infection (SSI) is one of the most common post-operative complications following cesarean section, with an incidence of 3-15% worldwide (Zuarez-Eaaston et al., 2017). Wound dressings that are applied after closure of a surgical incision may help healing by providing physical support, protection from external contaminants, and by absorbing exudate (Dumville et al., 2016). A new FDA-approved microbicidial liquid adhesive, Steri3X, has been shown to reduce the incidence of pin-tract infection by 100% in a randomized-controlled trial following external fixation in patients undergoing reconstructive surgery for deformity correction (Pema, 2020). Steri3X is reported to be effective against S. aureus (both MSSA and MRSA), Candida albicans, E. coli, P. aeruginosa, and Candida auris, which are common organisms involved in dermatological infections. The most common organisms responsible for cesarean section SSI include enteric gram negative bacilli, enterococci, and group B streptococcus (Gur et al., 2015). The advantage of this polymer following C-sections is unknown, and a larger study is needed to provide a more robust analysis. This study aims to determine the effect of Steri3X on the incidence of cesarean section SSI at Regional One Hospital.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Control | Active Comparator | Currently, the standard of care for Cesarean section patients includes covering the closed incision with a sterile bandage to reduce the chance of infection, and approximately 48 hours of post-op hospitalization and wound surveillance. The "control" group will receive post-operative wound dressings consistent with the current standard of care. |
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| Experimental | Experimental | Patients randomized to the Experimental group will receive treatment with Steri3x immediately following closure of the Cesarean section incision. Participants in the experimental group will receive approximately 48 hours of post-op hospitalization and wound surveillance. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Steri3X | Device | This study will initially attempt to recruit pregnant patients at the Regional One Health outpatient obstetrics clinic, at which point they will be randomly assigned to one of two cohorts. Participants who are consented to participate in the study will receive a chart flag in the EMR so that they may receive the proper intraoperative and postoperative treatment(s). Patients randomized to receive the Steri3X wound dressing will have the liquid polymer applied in the operating room after closure of the Cesarean section incision. Participants of both arms will be monitored postoperatively to assess for signs and symptoms of postoperative surgical site infection(s). |
| Measure | Description | Time Frame |
|---|---|---|
| Surgical Site Infection | Postoperative patients will be monitored for signs/symptoms of infection after Cesarean section during their inpatient postoperative stay and also during postpartum office visits. | 8 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Bethany Erickson, MD | Contact | 7012268304 | bericks5@uthsc.edu | |
| Joann Gold, MD | Contact | 3525855841 | jgold7@uthsc.edu |
| Name | Affiliation | Role |
|---|---|---|
| Ramona Phinehas, MD | University of Tennessee | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Regional One Health Medical Center | Memphis | Tennessee | 38103 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 16167416 | Background | Hsiung SH, Robins P. Evaluation of a flexible new liquid polymer wound dressing. J Drugs Dermatol. 2005 Sep-Oct;4(5):580-2. | |
| 18720693 | Background | Robins P, Goldberg L, Moy R, Nouri K, Perez M, Saini R, Sarnoff D, Spencer J. The effectiveness of liquid bandage as an adhesive and antimicrobial agent. J Drugs Dermatol. 2008 Aug;7(8):764-6. No abstract available. |
| Label | URL |
|---|---|
| Shital Pema, DPM. An Evaluation of the Use of a Novel Microbicidal Liquid Polymer for the Reduction of Pin-tract Infection in Research Participants Receiving External Fixation Following Deformity Correction and Traumatic Provisional Fixation. | View source |
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| ID | Term |
|---|---|
| D013530 | Surgical Wound Infection |
| D014947 | Wounds and Injuries |
| D007239 | Infections |
| ID | Term |
|---|---|
| D014946 | Wound Infection |
| D011183 | Postoperative Complications |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| Control | Other | Device: Steri3X This study will initially attempt to recruit pregnant patients at the Regional One Health outpatient obstetrics clinic, at which point they will be randomly assigned to one of two cohorts. Participants who are consented to participate in the study will receive a chart flag in the EMR so that they may receive the proper intraoperative and postoperative treatment(s). Patients randomized to receive the control wound dressing will have the current standard of care dressing applied in the operating room after closure of the Cesarean section incision. Participants of both arms will be monitored postoperatively to assess for signs and symptoms of postoperative surgical site infection(s). |
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| 20102279 | Background | Olsen MA, Butler AM, Willers DM, Gross GA, Hamilton BH, Fraser VJ. Attributable costs of surgical site infection and endometritis after low transverse cesarean delivery. Infect Control Hosp Epidemiol. 2010 Mar;31(3):276-82. doi: 10.1086/650755. |
| 28255256 | Background | 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. |
| 27996083 | Background | Dumville JC, Gray TA, Walter CJ, Sharp CA, Page T, Macefield R, Blencowe N, Milne TK, Reeves BC, Blazeby J. Dressings for the prevention of surgical site infection. Cochrane Database Syst Rev. 2016 Dec 20;12(12):CD003091. doi: 10.1002/14651858.CD003091.pub4. |