The Use of Steri3X for Prevention of Post-operative Wound Infections in Cesarean Sections

Surgical Site Infection Clinical Trial

Official title:

The Use of Steri3X for Prevention of Post-operative Wound Infections in Cesarean Sections

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05392400
• Other study ID #: 22-08663-FB
• Status: Not yet recruiting
• Phase: Phase 2
• Start date: February 7, 2023
• Est. completion date: February 7, 2024

Study information

• Verified date: May 2022
• Source: University of Tennessee
• Contact: Bethany Erickson, MD
• Phone: 7012268304
• Email: bericks5[@]uthsc.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 1000
• Est. completion date: February 7, 2024
• Est. primary completion date: February 7, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 16 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Cesarean Section; Complications, Wound, Infection (Following Delivery)
• Communicable Diseases
• Infections
• Surgical Site Infection
• Surgical Wound
• Surgical Wound Infection
• Wound Infection
• Wounds and Injuries

Intervention

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 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).

Other:
• Control
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).

Locations

Country	Name	City	State
United States	Regional One Health Medical Center	Memphis	Tennessee

Sponsors (1)

Lead Sponsor	Collaborator
University of Tennessee

Country where clinical trial is conducted

United States, 

References & Publications (5)

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. — View Citation

Hsiung SH, Robins P. Evaluation of a flexible new liquid polymer wound dressing. J Drugs Dermatol. 2005 Sep-Oct;4(5):580-2. — View 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. — View 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. — 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

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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

External Links

•   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.