Wound Irrigation for Cesarean Section Complications

Overseen By Ashra Denise Tugung, BS

Age: 18+

Sex: Female

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Recruiting

Sponsor: Loma Linda University

Disqualifiers: Emergency cesarean delivery

No Placebo Group

Approved in 1 Jurisdiction

Trial Summary

What is the purpose of this trial?

This investigator-initiated, open-label, randomized controlled trial will explore the effects of two treatment arms, comparing standard treatment with normal saline against Irrisept, a jet lavage solution containing a low concentration of Chlorhexidine Gluconate (CHG) at 0.05% in 99.95% sterile water for irrigation. The study aims to evaluate the impact on postoperative wound healing in patients who have undergone cesarean delivery.

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 wound irrigation generally safe for humans?

Research indicates that solutions like Lavasept and Irriclens (a 0.9% sodium chloride solution) are safe for wound irrigation, showing good tissue compatibility and no evidence of impaired wound healing. Lavasept also has a good anti-inflammatory effect, making it a safe choice for treating wounds. ^{1 2 3 4 5}

How does the treatment Irrisept differ from other treatments 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 help reduce infection risk. Unlike other treatments that use saline or povidone-iodine, Irrisept combines irrigation with an antimicrobial agent, potentially offering a more effective approach to preventing wound complications after cesarean sections. ^{2 6 7 8 9}

Research Team

Ruofan Yao, MD, MPH

Principal Investigator

Loma Linda University

Eligibility Criteria

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 can communicate in English or Spanish.

Exclusion Criteria

I had an emergency C-section.

Trial Timeline

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

Treatment Details

Interventions

• Irrisept (Antiseptic)
• Normal Saline (Procedure)

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.

Participant Groups

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.

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+

Findings from Research

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]

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 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]

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]

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 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]

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 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]

References

1. Germany 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]. [2019]

2. Australia 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. [2022]

3. Germany pubmed.ncbi.nlm.nih.gov

Bacterial decontamination of surgical wounds treated with Lavasept. [2018]

4. England pubmed.ncbi.nlm.nih.gov

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

5. United States pubmed.ncbi.nlm.nih.gov

The Effect of Different Irrigation Solutions on the Cytotoxicity and Recovery Potential of Human Osteoblast Cells In Vitro. [2022]

6. Ireland pubmed.ncbi.nlm.nih.gov

The impact of subcutaneous irrigation on wound complications after cesarean sections: A prospective randomised study. [2018]

7. England 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. [2022]

8. France pubmed.ncbi.nlm.nih.gov

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

9. United States pubmed.ncbi.nlm.nih.gov

Ineffectiveness of povidone-iodine irrigation of abdominal incisions. [2017]