Povidone-Iodine Irrigation for Appendicitis

Overseen By Debbie Nguyen

Age: 18+

Sex: Any

Trial Phase: Phase 4

Sponsor: The University of Texas Health Science Center, Houston

Disqualifiers: Iodine allergy, Thyroid issues, Renal dysfunction, Pregnant, others

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

Prior Safety Data This treatment has passed at least one previous human trial

Approved in 5 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 30

Duration: Immediate post-surgery

346 Participants Needed

Trial Summary

Will I have to stop taking my current medications?

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.

How does the treatment Povidone-Iodine differ from other treatments for appendicitis?

Povidone-Iodine irrigation is unique because it is used during surgery to wash out the abdominal area, which may help reduce the risk of infections like intra-abdominal abscesses after surgery for appendicitis. This approach is different from standard treatments that typically focus on antibiotics and surgical removal of the appendix without additional irrigation. ^{1 2 3 4 5}

What is the purpose of this trial?

The purpose of this study to assess the clinical effectiveness and cost-effectiveness of povidone-iodine (PVI) irrigation in perforated appendicitis, to investigate barriers and facilitators to future implementation of PVI irrigation, and to collect costs and clinical and patient-reported outcomes among patients with non-perforated appendicitis.

Research Team

Dalya Ferguson, MD, MS

Principal Investigator

The University of Texas Health Science Center, Houston

Eligibility Criteria

This trial is for individuals with acute appendicitis, particularly those who have a perforated appendix or an intra-abdominal abscess. The study aims to include patients who can provide informed consent and are eligible based on specific health criteria not detailed here.

Inclusion Criteria

Intraoperative diagnosis of perforated appendicitis

Enrolled in study preoperatively

I am scheduled for an appendectomy due to acute appendicitis.

Exclusion Criteria

I have kidney problems.

Allergy to iodine

Pregnant or breastfeeding

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive povidone-iodine (PVI) irrigation or usual care for perforated appendicitis

Immediate post-surgery

Follow-up

Participants are monitored for cost-effectiveness and clinical outcomes, including IAA rate and patient-reported costs

90 days

Multiple assessments at 30 days, 90 days, 6 months, and 12 months

Extended Follow-up

Long-term monitoring of health-related quality of life and postoperative complications

12 months

Treatment Details

Interventions

• Povidone-Iodine

Trial Overview The APPI-Cost Trial is testing the effectiveness of povidone-iodine (PVI) irrigation compared to usual care in treating perforated appendicitis. It also examines cost-effectiveness, implementation barriers and facilitators, and collects various outcomes data.

Participant Groups

Group I: PVI Active Control 1 Intervention

Group II: Usual Care Active Control 1 Intervention

Povidone-Iodine is already approved in European Union, United States, Canada, Japan for the following indications:

Approved in European Union as Betadine for:

• Antiseptic skin preparation
• Preoperative skin disinfection
• Wound care

Approved in United States as Betadine for:

• Preparation of skin prior to surgery
• Prevention of infection in minor cuts and scrapes
• Antiseptic skin preparation

Approved in Canada as PVP-I for:

• Antiseptic skin preparation
• Preoperative skin disinfection
• Wound care

Approved in Japan as Betadine for:

• Antiseptic skin preparation
• Preoperative skin disinfection
• Wound care

Who Is Running the Clinical Trial?

The University of Texas Health Science Center, Houston

Lead Sponsor

Trials

974

Recruited

361,000+

National Center for Advancing Translational Sciences (NCATS)

Collaborator

Trials

394

Recruited

404,000+

Findings from Research

In a study of 7566 patients undergoing open-heart surgery, the use of 10% povidone-iodine (PVP-I) for skin and wound disinfection resulted in a low incidence of severe infections, with only 0.5% experiencing deep sternal or retrosternal infections.

While superficial wound healing defects occurred in 5% of patients and were easily treatable with local PVP-I application, deep infections posed a significant risk, leading to a 40% mortality rate, highlighting the importance of strict aseptic techniques and effective antibiotic use.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Ten years experience with povidone-iodine in heart surgery. Klövekorn, WP., Meisner, H., Sebening, F.[2019]

References

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

Povidone-iodine Irrigation for Pediatric Perforated Appendicitis May Be Protective: A Bayesian Pilot Randomized Controlled Trial. [2021]

2. Denmark pubmed.ncbi.nlm.nih.gov

Is povidone-iodine a hemostyptic? A clinical study. [2022]

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

Povidone-iodine intra-abdominal irrigation versus no irrigation in pediatric perforated appendicitis: A secondary economic analysis of a Bayesian randomized controlled trial. [2023]

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

Randomised trial of intraperitoneal irrigation with low molecular weight povidone-iodine solution to reduce intra-abdominal infectious complications. [2019]

5. England pubmed.ncbi.nlm.nih.gov

Ten years experience with povidone-iodine in heart surgery. [2019]