Clinical trial NCT05392400: The Use of Steri3X for Prevention of Post-operative Wound Infections in Cesarean Sections
Official title: The Use of Steri3X for Prevention of Post-operative Wound Infections in Cesarean Sections
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Surgical Site Infection
Cesarean Section; Complications, Wound, Infection (Following Delivery)
Postpartum Complication
Keywords: Intrauterine infection, cesarean, postpartum endometritis, surgical site infection, postoperative wound infection
Lead sponsor: University of Tennessee
Sponsor class: OTHER
First posted: 2022-05-26
Enrollment: 1000
Sex: FEMALE
Minimum age (years): 16
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* Age 16 years old or older
* C-section patients only (primary, repeat, or stat)
* Diabetes, obesity ok to include (but not required)
* Patients receiving PCN for GBS prophylaxis ok to include (but not required)
* Application of Steri3X immediately post-op

Exclusion Criteria:

* Chorioamnionitis or other existing infection excluded (Single maternal fever \>39 C, 2 maternal fevers \> 38, or clinical risk factors for chorioamnionitis)
* Patients receiving antibiotic treatment for existing or prior infection other than PCN for GBS prophylaxis
* Patients receiving Prevena or other wound vac
* Rupture of membranes \>24 hours

Primary outcomes:
measure: Surgical Site Infection
timeFrame: 8 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Memphis
country: United States
facility: Regional One Health Medical Center
state: Tennessee
Study officials:
affiliation: University of Tennessee
name: Ramona Phinehas, MD
role: STUDY_DIRECTOR
References:
citation: Hsiung SH, Robins P. Evaluation of a flexible new liquid polymer wound dressing. J Drugs Dermatol. 2005 Sep-Oct;4(5):580-2.
citation: 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.
citation: 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.
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.
citation: 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.