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)

1750 Participants Needed

Trial Summary

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 data supports the effectiveness of the treatment Povidone-iodine irrigation for appendicitis?

Research shows that using povidone-iodine irrigation in children with perforated appendicitis has an 89% probability of reducing the rate of intra-abdominal abscesses compared to not using irrigation. ^{1 2 3 4 5}

Is povidone-iodine irrigation safe for use in humans?

Povidone-iodine is generally safe for use in humans, though it can cause allergic reactions ranging from minor skin irritation to severe reactions like anaphylaxis (a serious allergic reaction). In studies, no toxic effects were recorded, and iodine levels in the body returned to normal within 72 hours after use. ^{1 2 3 6 7}

How does the treatment povidone-iodine irrigation differ from other treatments for appendicitis?

Povidone-iodine irrigation is unique because it involves washing the abdominal area with a solution to reduce the risk of intra-abdominal abscesses (collections of pus) after surgery for perforated appendicitis, which is different from standard treatments that may not include this step. This method has shown a high probability of reducing abscess rates compared to no irrigation. ^{1 2 3 4 8}

What is the purpose of this trial?

The purpose of this study is to determine the effect of intra-abdominal irrigation with povidone-iodine (PVI) versus usual care on the rate of 30-day postoperative intra-abdominal abscesses (IAA) and to determine the effect of PVI irrigation versus usual care on 30-day hospital length of stay(LOS) and 30-day readmissions.

Research Team

Kuojen Tsao, MD

Principal Investigator

The University of Texas Health Science Center, Houston

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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. 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]

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

Intraperitoneal irrigation with povidone-iodine solution for the prevention of intra-abdominal abscesses in the bacterially contaminated abdomen. [2017]

4. Germany pubmed.ncbi.nlm.nih.gov

[Effect of intraoperative local polyvinylpyrrolidone iodine administration on the risk of wound infection following appendectomy]. [2017]

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

Povidone-iodine irrigation of the subcutaneous tissue to prevent surgical wound infections. [2017]

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

Late-onset allergic reaction to povidone-iodine resulting in vulvar edema and urinary retention. [2021]

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

Combined preoperative antibiotic therapy and intraoperative topical povidone-iodine. Reduction of wound sepsis following emergency appendectomy. [2019]

8. England pubmed.ncbi.nlm.nih.gov

Combined topical povidone-iodine and systemic antibiotics in postappendicectomy wound sepsis. [2019]