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Surgical Site InfectionPhase 2NCT05392400

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

A Phase 2 study testing Steri3X in people with Surgical Site Infection and Cesarean Section; Complications, Wound, Infection (Following Delivery), run by University of Tennessee at 1 site in United States.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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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. Read more about this study

Who is it for?
Ages 16 years and older, women onlyHealthy volunteers can take part
What is being tested?
Steri3X
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
1,000 participants
Where
1 siteUnited States
Study dates
7 Feb 2023to 7 Feb 2024
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 16 years and older
  • Women only
  • Healthy volunteers accepted
  • Child, Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

Bethany Erickson, MD contact

7012268304

bericks5@uthsc.edu

Joann Gold, MD contact

3525855841

jgold7@uthsc.edu

United States1 site

  • Regional One Health Medical Center

    Memphis, Tennessee, 38103

    Bethany Erickson, MD, 901-448-2531, bericks5@uthsc.edu

    Rachel Nelson, MD PhD, 615-587-5832, rnelso25@uthsc.edu

Other trials in United States

About this study

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.

Read the 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.

Being tested
Steri3X, Control
Keywords
Intrauterine infection, cesarean, postpartum endometritis, surgical site infection, postoperative wound infection
Medical subject headings
Surgical Wound Infection, Wounds and Injuries, Infections

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Steri3XDevice

    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).

  • ControlOther

    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).

Study groups in NCT05392400
Study groupRoleWhat they receive
ControlActive comparatorCurrently, 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.
Receives: Other: Control
ExperimentalExperimentalPatients 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.
Receives: Device: Steri3X

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: 8 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted26 May 2022
  2. Study start7 Feb 2023 (estimated)
  3. Primary completion7 Feb 2024 (estimated)
  4. Study completion7 Feb 2024 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
1,000 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05392400
Sponsor's protocol ID
22-08663-FB
Status last verified
May 2022
First submitted
22 May 2022
Last updated
13 Feb 2023
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
Yes
Individual data sharing
No

Publications

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

    PubMed 16167416

  • 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.

    PubMed 18720693

  • 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.

    PubMed 20102279

  • 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.

    PubMed 28255256

  • 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.

    PubMed 27996083

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Steri3X in people with Surgical Site Infection and Cesarean Section; Complications, Wound, Infection (Following Delivery), run by University of Tennessee at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 13 Feb 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Bethany Erickson, MD (7012268304, bericks5@uthsc.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Surgical Site Infection (time frame: 8 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05392400, which also lists 5 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Feb 2023.

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