Wound Irrigation for Cesarean Section Complications

Overseen By Ashra Denise Tugung, BS

Age: 18+

Sex: Female

Trial Phase: Academic

Sponsor: Loma Linda University

Disqualifiers: Emergency cesarean delivery

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 1 Jurisdiction This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

Duration: Immediate postoperative period

400 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests two solutions to determine which aids wound healing better after a cesarean section. One group will receive a standard saline wash, while the other will use Irrisept, a new rinse with a mild antiseptic. The research focuses on improving recovery for individuals who may face healing challenges after a C-section. Women scheduled for a planned C-section at 37 weeks or later, with conditions such as obesity, diabetes, or infection, are suitable candidates for this trial. As an unphased trial, it offers a unique opportunity to contribute to research that could enhance recovery for future patients.

Do I need to stop my current medications for this trial?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that Irrisept, a cleaning solution containing a small amount of Chlorhexidine Gluconate (CHG), is very safe to use. Studies conducted both in labs and on people indicate that this treatment is usually well-tolerated. Over 12 years of testing and use have provided extensive information about its safety.

The solution has been applied in various situations and remains gentle on the body. Studies have not reported any major adverse side effects, which is reassuring for those considering participation in a trial using Irrisept. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Researchers are excited about Irrisept for treating Cesarean section complications because it introduces a novel delivery method called jet lavage. Unlike the standard saline solution which is simply poured over the wound, Irrisept uses a pressurized system to cleanse the area more effectively. This method could potentially reduce infection rates and improve healing time by ensuring a more thorough irrigation.

What evidence suggests that this trial's treatments could be effective for postoperative wound healing in cesarean section patients?

In this trial, participants will receive either Irrisept or Normal Saline for wound irrigation following cesarean sections. Research has shown that Irrisept, a cleaning solution with Chlorhexidine Gluconate (CHG), effectively cleans wounds and removes dead tissue. Its strong germ-fighting abilities help protect against various germs. Although one study found no difference in infection rates after cesarean sections with CHG irrigation, Irrisept has been used safely and effectively for over 12 years in different settings. Lab and real-world studies have demonstrated its safety and effectiveness in wound care. Its unique gentle jet spray method may enhance wound healing after cesarean deliveries. ^{1 2 3 4 5}

Who Is on the Research Team?

Ruofan Yao, MD, MPH

Principal Investigator

Loma Linda University

Are You a Good Fit for This Trial?

This trial is for adults over 18 with a single pregnancy planning a cesarean delivery at or after 37 weeks gestation, who will follow up post-op at Loma Linda OBGYN. Participants must speak English or Spanish and have obesity, diabetes, ruptured membranes, or intraamniotic infection. Emergency C-sections are excluded.

Inclusion Criteria

Singleton pregnancy

Planned cesarean delivery at gestational age 37 weeks or later at Loma Linda University Children's Hospital

I have obesity, diabetes, or have experienced membrane rupture or an infection in the amniotic fluid.

Exclusion Criteria

I had an emergency C-section.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive either normal saline or Irrisept for wound irrigation following cesarean section

Immediate postoperative period

Follow-up

Participants are monitored for wound healing using a composite wound evaluation scale

8 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Irrisept
• Normal Saline

Trial Overview The study compares two methods of cleaning the wound during C-section: standard normal saline versus Irrisept (a jet lavage with low-concentration Chlorhexidine). It aims to see which is better for healing after surgery.

How Is the Trial Designed?

Group I: Irrisept Experimental Treatment 1 Intervention

The experimental arm will receive irrigation solution Irrisept administered through a proprietary bottle (jet lavage) following the closure of the fascia in Cesarean section.

Group II: Normal Saline Active Control 1 Intervention

The active comparator arm will receive the standard of care irrigation solution, normal saline, administered via standard pour over following the closure of the fascia in Cesarean section.

Irrisept is already approved in United States for the following indications:

Approved in United States as Irrisept for:

• Mechanical cleansing and removal of debris, dirt, and foreign materials, including microorganisms from wounds

Who Is Running the Clinical Trial?

Loma Linda University

Lead Sponsor

Trials

322

Recruited

267,000+

Irrimax Corporation

Industry Sponsor

Trials

11

Recruited

2,100+

Published Research Related to This Trial

In a study of 300 patients undergoing caesarean sections, irrigation of subcutaneous tissue with rifampicin or 10% povidone-iodine did not significantly reduce the rate of surgical site infections compared to saline alone.

The research highlighted that factors such as comorbidities, perioperative blood transfusions, and midline incisions were associated with a higher risk of incisional surgical site infections, emphasizing the need for careful patient assessment in surgical planning.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Subcutaneous irrigation with rifampicin vs. povidone-iodine for the prevention of incisional surgical site infections following caesarean section: a prospective, randomised, controlled trial. Kömürcü Karuserci, Ö., Sucu, S.[2022]

In a study of 50 acutely injured patients with contaminated soft tissue wounds, treatment with 0.2% Lavasept showed a significant and faster reduction in harmful microorganisms compared to Ringer solution.

Lavasept not only demonstrated better anti-inflammatory effects and tissue compatibility but also did not impair wound healing, making it a promising antiseptic option for wound care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Bacterial decontamination of surgical wounds treated with Lavasept. Fabry, W., Trampenau, C., Bettag, C., et al.[2018]

Bacitracin and Clorpactin were found to be damaging to human osteoblast cells in vitro, but the damage was at least partially reversible, as cells returned to normal morphology after a week.

Irrisept (chlorhexidine) caused the most significant and irreversible damage to osteoblasts, indicating it may not be a safe option for irrigation during joint surgeries.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Effect of Different Irrigation Solutions on the Cytotoxicity and Recovery Potential of Human Osteoblast Cells In Vitro. Markel, JF., Bou-Akl, T., Dietz, P., et al.[2022]

In a network meta-analysis of 29 randomized clinical trials involving 9311 women, povidone-iodine was found to significantly reduce the risk of post-cesarean endometritis compared to no vaginal cleaning, suggesting its effectiveness as a pre-cesarean wash solution.

Chlorhexidine 4% and saline 0.9% also showed significant reductions in post-cesarean wound infections, fever, and hospital stay duration, indicating that vaginal wash solutions can improve outcomes after cesarean sections.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Vaginal preparation with different antiseptic solutions before cesarean section for preventing postoperative infections: A systematic review and network meta-analysis. Fadlalmola, HA., Al-Sayaghi, KM., Al-Hebshi, AA., et al.[2022]

In a study of 226 pregnant women undergoing elective cesarean sections, preoperative vaginal cleansing with 10% povidone-iodine significantly reduced overall post-surgical infectious morbidities from 20.7% to 7.5%.

The most notable reduction was in the incidence of endometritis, which decreased from 11.8% in the control group to 2.8% in the intervention group, highlighting the efficacy of this cleansing method.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Vaginal cleansing prior to caesarian section: To do or not to do?: A randomized trial. Aref, NK.[2019]

In a study of patients undergoing gynecologic operations without prophylactic antibiotics, wound irrigation with povidone-iodine did not significantly reduce the incidence of wound infections compared to a control group.

The findings suggest that povidone-iodine irrigation alone is ineffective in preventing infections in contaminated surgical wounds, indicating that additional preventive measures may be necessary.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Ineffectiveness of povidone-iodine irrigation of abdominal incisions. Galle, PC., Homesley, HD.[2017]

Irriclens is the first aerosol wound cleanser, offering a sterile 0.9% sodium chloride solution that can effectively cleanse and irrigate wounds, potentially improving convenience and ease of use.

This product may be more cost-effective than traditional antiseptics, as it minimizes waste and reduces the need for additional equipment during wound care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Irriclens: a sterile wound cleanser in an aerosol can. Williams, C.[2015]

In a study of 204 women undergoing primary cesarean sections, subcutaneous saline irrigation did not significantly reduce the rates of superficial surgical site infections (SSI) compared to the control group (14.3% vs 12.8%).

However, the saline irrigation group experienced significantly lower occurrences of hematoma and seroma, suggesting that while it may not prevent infections, it can help reduce other wound complications.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The impact of subcutaneous irrigation on wound complications after cesarean sections: A prospective randomised study. Aslan Çetin, B., Aydogan Mathyk, B., Barut, S., et al.[2018]

Lavasept (0.1%) is recommended as the best choice for treating deep and chronic wounds, as well as for antiinfective lavage of body cavities, including peritoneal lavage (0.05%).

Taurolidin is effective for long-term antiseptic use and is particularly suitable for peritoneal lavage due to its antitoxic properties and lack of cytotoxicity.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Explant test with skin and peritoneum of the neonatal rat as a predictive test of tolerance of local anti-infective agents in wounds and body cavities]. Kramer, A., Adrian, V., Rudolph, P., et al.[2019]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11995975/

Chlorhexidine Gluconate Irrigation in the Prevention of ... This single center retrospective observational study revealed no difference in post-cesarean SSI rates when performing intra-abdominal and subcutaneous ...

2. withpower.com withpower.com/trial/phase-complications-cesarean-section-5-2024-681f9

Wound Irrigation for Cesarean Section Complications Irrisept is unique because it is an antimicrobial wound lavage system specifically designed to clean and debride (remove dead tissue from) wounds, which may ...

3. irrisept.com irrisept.com/

Irrisept: Home Irrisept is a self-contained jet lavage delivering low-pressure irrigation. It contains Chlorhexidine Gluconate (CHG), a preservative, to offer broad spectrum ...

4. clinicaltrials.gov clinicaltrials.gov/study/NCT06339203

Wound Irrigation With Saline Versus Hypodilute ... The study aims to evaluate the impact on postoperative wound healing in patients who have undergone cesarean delivery. Official Title. Wound Irrigation With ...

5. irrisept.com irrisept.com/research/

Research Irrisept features an extensive safety profile with in-vitro and in-vivo studies and RCT data, with >12 years of proven history and testing.