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RecruitingNCT06454227Updated Mar 19, 2025

Subcutaneous Lavage in Cesarean Section

An interventional study of Subcutaneous washing and no subcutaneous washing in Surgical Site Infection, sponsored by Hadassah Medical Organization. Recruiting at 1 site in Israel. Open to female participants, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-03-19.

Sponsored by Hadassah Medical Organization · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Started Sep 2024; still recruiting 2 years later.
Phase
Not applicable
Study type
Interventional
Enrollment
600
Allocation
Randomized
Sex
Female
01

Study summary

The goal of this clinical trial is to learn if antiseptic washing prior to skin closure during cesarean section reduces rates of surgical site infection.

intraoperative washing is a common practice in other surgical fields and several studies have shown efficacy in reducing postoperative infection rates. no randomized control trial has tested this intervention during cesarean section.

The main questions we aim to answer are:

Does subcutaneous antiseptic washing reduce the rates of surgical site infection? Does antiseptic washing improve scar healing? Does antiseptic washing reduce hospital stay, postpartum fever rates and readmission cases?

Researchers will compare subcutaneous antiseptic washing to no intervention to see if surgical site infection rates reduce

Participants will:

consent to participate in the trial Visit the postpartum clinic 30 days after surgery

02

Conditions studied

  • Surgical Site Infection
03

In context

Surgical Wound Infection

670 studies on the registry are indexed under Surgical Wound Infection; 141 are open to participants now.

This study's planned enrollment of 600 is above the median of 200 across 514 interventional studies indexed under Surgical Wound Infection.

Browse Surgical Wound Infection studies →

Lead sponsor

Hadassah Medical Organization is the lead sponsor of 659 studies on the registry; 54 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
Female
Accepts healthy volunteers
Yes

Inclusion criteria

  • pregnant women undergoing cesarean delivery

Exclusion criteria

Exclusion Criteria:

  • pregnant women undergoing vaginal delivery
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Single group
Masking
Double (Participant, Outcomes assessor)
Enrollment
600 participants (estimated)

Study arms

  • Active comparator
    Subcutan lavage

    Subcutaneous washing with antiseptic solution: Chlorhexidine gluconate 0.2%

    Procedure: Subcutaneous washing

  • Placebo comparator
    no lavage

    No subcutaneous washing

    Procedure: no subcutaneous washing

Interventions

  • ProcedureSubcutaneous washing

    subcutaneous washing with chlorhexidine gluconate prior to skin closure

  • Procedureno subcutaneous washing

    no washing

06

What researchers measure

Primary outcomes

  1. surgical site infection

    SSI infection rates

    Time frame: 30 days after surgery

Secondary outcomes

  1. hospital stay

    length of hospital stay

    Time frame: 30 days after surgery

  2. wound healing

    assessment of the healing according to Southampton criteria: presence of inflammation, erythema or discharge

    Time frame: 30 days after surgery

  3. postpartum fever

    fever recording

    Time frame: 30 days after surgery

07

Study locations

1 of 1 sites recruiting
  • Hadassah Medical Organization
    Jerusalem, Israel
    Recruiting
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 19, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06454227
Lead sponsor
Hadassah Medical Organization
Responsible party
Sponsor
First posted
Jun 12, 2024
Start date
Sep 22, 2024
Primary completion
Oct 1, 2027 (estimated)
Completion
Dec 1, 2028 (estimated)
Last update
Mar 19, 2025

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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No contact was published for this record. The registry link below has the sponsor’s details.

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