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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether washing the area with povidone-iodine, a common antiseptic, can improve treatment outcomes for those undergoing surgery for perforated appendicitis. Researchers aim to determine if this method is both effective and cost-efficient compared to usual care. The trial will compare two groups: one receiving povidone-iodine irrigation and the other receiving standard treatment. Individuals planning surgery for a burst appendix, without an iodine allergy or other listed conditions, might be suitable for this study. As a Phase 4 trial, this research involves an FDA-approved treatment and seeks to understand how it can benefit more patients.

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.

What is the safety track record for povidone-iodine?

Past research has examined povidone-iodine (PVI) for treating appendicitis. Studies have shown that using PVI to wash out the area during surgery can reduce the risk of abscesses (pockets of pus) after surgery for a burst appendix, potentially aiding smoother recovery. One study found that PVI washing could also shorten hospital stays post-surgery.

Povidone-iodine is generally well-tolerated, with most people not experiencing negative reactions. However, some may encounter minor side effects like skin irritation. Overall, existing evidence suggests that PVI is safe for use in surgeries, and its widespread use for other medical purposes supports its safety. ^{1 2 3 4 5}

Why are researchers enthusiastic about this study treatment?

Unlike the usual care for appendicitis, which often involves antibiotics and surgery, Povidone-Iodine (PVI) irrigation introduces a distinct approach by using an antiseptic wash directly in the abdominal area during surgery. This method is unique because it aims to reduce infection rates more effectively by directly targeting bacteria in the surgical site with its strong antiseptic properties. Researchers are excited about this treatment as it could potentially enhance recovery and minimize complications, offering a safer and more efficient alternative to traditional methods.

What evidence suggests that povidone-iodine irrigation is effective for appendicitis?

In this trial, participants will receive either povidone-iodine irrigation or usual care for appendicitis. Research has shown that povidone-iodine, an antiseptic, may help treat perforated appendicitis. Studies have found that it can lower the risk of developing an abscess, a pus collection that can form after an infection. It may also reduce hospital costs within 30 days, making it both effective and cost-efficient. Some studies suggest that povidone-iodine can help reduce infections at the surgery site after procedures like an appendectomy. Overall, evidence indicates that povidone-iodine is a good option for treating this condition. ^{1 4 5 6 7}

Who Is on the Research Team?

Dalya Ferguson, MD, MS

Principal Investigator

The University of Texas Health Science Center, Houston

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12317621/

Evaluating the efficacy of dilute povidone-iodine versus ... Findings from our study found no difference in effectiveness of povidone-iodine and normal saline in preventing SSI after appendectomy. SSI is ...

2. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0002961023005184

Povidone-iodine intra-abdominal irrigation versus no ... Irrigation with povidone-iodine may prevent abscess after perforated appendicitis. •. Povidone-iodine irrigation was associated with lower 30-day mean hospital ...

3. americanjournalofsurgery.com americanjournalofsurgery.com/article/S0002-9610(23)00518-4/abstract

Povidone-iodine intra-abdominal irrigation versus no ... Irrigation with povidone-iodine may prevent abscess after perforated appendicitis. •. Povidone-iodine irrigation was associated with lower 30-day mean hospital ...

4. applications.emro.who.int applications.emro.who.int/imemrf/J_Bahria%20Univ_Med_Dent_Coll/J_Bahria%20Univ_Med_Dent_Coll_2018_8_4_214_217.pdf

To Evaluate Povidone-iodine Effect On Post ... In present randomized clinical trial, the efficacy of 1%. Povidone- iodine against surgical site infection (SSI) was noted in post- appendectomy patients ...

5. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/37863798/

Povidone-iodine intra-abdominal irrigation versus no ... PVI likely reduced the IAA rate and 30-day hospital costs, suggesting the intervention is both clinically superior and cost saving.

6. impactfactor.org impactfactor.org/PDF/IJPCR/15/IJPCR,Vol15,Issue12,Article39.pdf

Comparative Study of Irrigation with Povidone-Iodine versus ... The goal of this research is to examine the percentage of superficial SSI after appendectomy with 1% povidone-iodine solution intraoperative ...

7. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/31567357/

Povidone-iodine Irrigation for Pediatric Perforated ... Conclusions: PVI irrigation for perforated appendicitis in children demonstrated a strong probability of reduction in postoperative IAA with a high probability ...