Surgical Site InfectionNCT06454227
Subcutaneous Lavage in Cesarean Section
A study testing Subcutaneous washing and no subcutaneous washing in people with Surgical Site Infection, run by Hadassah Medical Organization at 1 site in Israel.
Trial 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. Read more about this study
- Who is it for?
- Any age, women onlyHealthy volunteers can take part
- Conditions the study is for
- Surgical Site Infection
- What is being tested?
- Subcutaneous washing and no subcutaneous washing
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 600 participants
- Where
- 1 siteIsrael
- Study dates
- 22 Sep 2024to 1 Dec 2028
- Phase
- Interventional
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 Any age
- Women only
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- pregnant women undergoing cesarean delivery
Who cannot join
- pregnant women undergoing vaginal delivery
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Israel1 site, 1 recruiting
- Recruiting
Hadassah Medical Organization
Jerusalem
Hadas Lemberg, PhD, 00 972 2 6777572, lhadas@hadassah.org.il
About this study
Official title: Antiseptic Washing Prior to Skin Closure During Cesarean Delivery- a Randomized Control Trial
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.
Read more
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
- Conditions
- Surgical Site Infection
- Being tested
- Subcutaneous washing, no subcutaneous washing
- Medical subject headings
- Surgical Wound Infection
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Subcutaneous washingProcedure or surgery
subcutaneous washing with chlorhexidine gluconate prior to skin closure
no subcutaneous washingProcedure or surgery
no washing
| Study group | Role | What they receive |
|---|---|---|
| Subcutan lavage | Active comparator | Subcutaneous washing with antiseptic solution: Chlorhexidine gluconate 0.2% Receives: Procedure: Subcutaneous washing |
| no lavage | Placebo comparator | No subcutaneous washing Receives: Procedure: no subcutaneous washing |
What is being measured
The primary outcome is the main question the study is designed to answer.
surgical site infection
SSI infection rates
Measured: 30 days after surgery
Secondary outcomes (3)
hospital stay
length of hospital stay
Measured: 30 days after surgery
wound healing
assessment of the healing according to Southampton criteria: presence of inflammation, erythema or discharge
Measured: 30 days after surgery
postpartum fever
fever recording
Measured: 30 days after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jun 2024
- Study start22 Sep 2024
- Primary completion1 Oct 2027 (estimated)
- Study completion1 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Surgical Site InfectionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 600 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hadassah Medical Organization
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06454227
- Sponsor's protocol ID
- WASHCD-HMO-CTIL
- Status last verified
- May 2024
- First submitted
- 7 May 2024
- Last updated
- 19 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No