Povidone-Iodine Irrigation for Appendicitis

(PAPPA Trial)

Overseen By Kuojen Tsao, MD

Age: < 18

Sex: Any

Trial Phase: Phase 4

Sponsor: The University of Texas Health Science Center, Houston

Disqualifiers: Iodine allergy, Thyroid disease, Renal dysfunction, Pregnancy, 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

Compensation: Varies

Number of Visits: Unknown

Duration: Immediate (during surgery)

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial examines whether washing the inside of the abdomen with a povidone-iodine solution (an antiseptic) can reduce complications after surgery for a burst appendix. The researchers aim to determine if this method decreases infection rates, shortens hospital stays, and reduces the need for readmission within 30 days post-surgery. This approach is compared to the usual post-surgery care. Individuals who have undergone surgery for a burst appendix and received this diagnosis during the operation might be suitable candidates for this trial. As a Phase 4 trial, the research focuses on understanding how this FDA-approved and effective treatment can benefit more 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.

What is the safety track record for povidone-iodine and usual care?

Research has shown that povidone-iodine (PVI) is generally safe for treating appendicitis. Studies have found that using PVI to wash out the area during surgery may help prevent abscesses, which are pockets of pus, after a burst appendix.

One study found that PVI reduced complications after surgery without causing extra harm to patients. Another study, which closely monitored safety, did not find any significant increase in side effects when using PVI compared to other treatments. These findings suggest that PVI is well-tolerated during surgery.

This trial is in phase 4, indicating that the treatment has already undergone extensive safety testing in earlier phases. Overall, strong evidence supports the safe use of PVI in appendicitis surgery. ^{1 2 3 4 5}

Why are researchers enthusiastic about this study treatment?

Researchers are excited about using povidone-iodine for treating appendicitis because it offers a unique approach compared to traditional treatments like antibiotics and surgery. Povidone-iodine works as an antiseptic, reducing the risk of infection by directly irrigating the affected area during surgery. This method could potentially decrease the chances of postoperative complications and speed up recovery time, offering a safer and more efficient alternative to the standard care.

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

Research has shown that povidone-iodine, a type of antiseptic, can lower the risk of abscesses (pockets of pus) after surgery for a burst appendix. In this trial, participants in the "Irrigation with PVI" arm will receive povidone-iodine treatment. Studies have found that patients who received povidone-iodine had fewer abscesses and spent less time in the hospital after surgery, suggesting it might improve recovery. However, some studies also mention that while it reduces abscesses, it might increase the chance of developing scar tissue. Overall, povidone-iodine has proven effective in treating certain conditions, like appendicitis, by fighting infection and aiding recovery. ^{2 4 5 6 7}

Who Is on the Research Team?

Kuojen Tsao, MD

Principal Investigator

The University of Texas Health Science Center, Houston

Are You a Good Fit for This Trial?

This trial is for children with a confirmed diagnosis of perforated appendicitis who are undergoing an appendectomy at a participating center. It's not for those who tried non-surgical treatment first, have simple or gangrenous appendicitis, are pregnant, or have iodine allergy, thyroid issues, or kidney problems.

Inclusion Criteria

I had my appendix removed due to acute appendicitis.

Intraoperative diagnosis of perforated appendicitis

Admitted to a participating center

Exclusion Criteria

I have been diagnosed with appendicitis.

I have had my appendix removed, either planned or by chance.

I have a history of iodine allergy, thyroid issues, or kidney problems.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo intra-abdominal irrigation with povidone-iodine or receive usual care during surgery

Immediate (during surgery)

Follow-up

Participants are monitored for 30 days post-surgery for intra-abdominal abscesses, length of hospital stay, and readmissions

30 days

What Are the Treatments Tested in This Trial?

Interventions

• Povidone-iodine
• Usual care

Trial Overview

The study is testing if washing out the inside of the abdomen with povidone-iodine (PVI) during surgery can reduce abscesses after operation compared to usual care. The impact on hospital stay and readmissions within 30 days post-surgery will also be evaluated.

How Is the Trial Designed?

Group I: Irrigation with PVI Experimental Treatment 1 Intervention

Group II: Usual care Active Control 1 Intervention

Who Is Running the Clinical Trial?

The University of Texas Health Science Center, Houston

Lead Sponsor

Trials

974

Recruited

361,000+

Published Research Related to This Trial

In a study involving 592 patients undergoing general surgery, irrigation of subcutaneous tissue with povidone-iodine solution did not reduce the incidence of postoperative wound infections.

The lack of benefit was consistent across the entire patient group and various subgroups, regardless of the level of bacterial contamination.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Povidone-iodine irrigation of the subcutaneous tissue to prevent surgical wound infections. de Jong, TE., Vierhout, RJ., van Vroonhoven, TJ.[2017]

Povidone-iodine can cause allergic reactions that may occur 24 hours after exposure, which is later than the typical immediate reactions usually associated with this antiseptic.

In this case, a patient experienced acute urinary retention due to extensive vulvar edema after surgery, highlighting the need for clinicians to consider delayed allergic reactions and atypical symptoms in postoperative patients exposed to povidone-iodine.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Late-onset allergic reaction to povidone-iodine resulting in vulvar edema and urinary retention. Rahimi, S., Lazarou, G.[2021]

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.

withpower.com

withpower.com/trial/phase-4-appendicitis-11-2024-62762

Povidone-Iodine Irrigation for Appendicitis

Trial Overview The APPI-Cost Trial is testing the effectiveness of povidone-iodine (PVI) irrigation compared to usual care in treating perforated appendicitis.

5.

jpedsurg.org

jpedsurg.org/article/S0022-3468(24)01043-1/abstract

Intra-peritoneal Povidone-iodine Irrigation Decreases ...

Conclusion. Povidone-iodine irrigation decreases intra-abdominal abscess formation, but increases adhesion formation.

6.

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 ...

7.

cdn.clinicaltrials.gov

cdn.clinicaltrials.gov/large-docs/20/NCT02664220/Prot_SAP_000.pdf

A Randomized Pilot Trial of Dilute Povidone-iodine ...

independent Data & Safety Monitoring Board to ensure there are no increased harms of PVI and that ongoing study participation is not futile ...