Perforated AppendicitisPhase 4NCT06705842
APPI-Cost Trial for Perforated Appendicitis
A Phase 4 study testing PVI in people with Perforated Appendicitis, run by The University of Texas Health Science Center, Houston at 1 site in United States.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Perforated Appendicitis
- What is being tested?
- PVI
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 346 participants
- Where
- 1 siteUnited States
- Study dates
- 7 Apr 2025to 31 Mar 2027
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Plan to undergo appendectomy for acute appendicitis
- Enrolled in study preoperatively
- Intraoperative diagnosis of perforated appendicitis
Who cannot join
- Preoperative hemodynamic instability requiring ongoing infusion of vasopressors
- Allergy to iodine
- Uncontrolled hyper- or hypothyroidism
- Renal dysfunction
- Pregnant or breastfeeding
- Primary language neither English nor Spanish
Show all 10Show fewer
- Lack of functioning telephone or email account
- Incarcerated or in police custody
- Eligibility for Randomization
- Non-perforated appendicitis
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
The University of Texas Health Science Center at Houston
Houston, Texas, 77030
Dalya Ferguson, MD, MS, (713) 500-7640, Dalya.M.Ferguson@uth.tmc.edu
Debbie Nguyen, (713) 566-5098, Debbie.F.Lew@uth.tmc.edu
About this study
Official title: The APPI-Cost Trial: Cost Assessment of Povidone-Iodine Irrigation for Prevention of Intra-abdominal Abscess in Perforated Appendicitis
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.
- Conditions
- Perforated Appendicitis
- Being tested
- PVI, Usual Care
- Keywords
- Perforated Appendicitis, Povidone Iodine, Cost effectiveness, Intra-abdominal abscess, Appendectomy, Implementation science
- Medical subject headings
- Appendicitis, Abdominal Abscess
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PVIDrug
After removal of the appendix from the patient's abdomen and attainment of hemostasis, 10 mL/kg of 1% PVI (up to a maximum of 1,000 mL) will be used to irrigate the pelvis and right upper and lower quadrants. The solution will be left to dwell for 1 minute and then suctioned out
Usual CareDrug
Surgeons may utilize local irrigation with saline if deemed necessary, defined as instillation of a small volume (<100 mL) of liquid followed by aspiration, for the purpose of confirming hemostasis or suctioning thick fluid. Some surgeons may utilize large volume irrigation with saline solution, if that is consistent with their usual practice. Patients in the usual care arm will not receive PVI irrigation.
| Study group | Role | What they receive |
|---|---|---|
| PVI | Active comparator | Not described Receives: Drug: PVI |
| Usual Care | Active comparator | Not described Receives: Drug: Usual Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cost-effectiveness of PVI relative to usual care
Cost-effectiveness of PVI irrigation relative to usual care will be assessed as the incremental 30-day total societal costs per percent reduction in IAA rate. The Incremental Cost Effectiveness Ratio (ICER) will be calculated as: (societal costs with PVI irrigation minus societal costs with usual care) divided by (IAA rate with PVI minus IAA rate with usual care). IAA will be defined as an image-confirmed fluid collection deemed to be an IAA by an attending surgeon or radiologist, or an abscess confirmed during percutaneous intervention or reoperation. Societal costs will be defined as patient-reported costs plus medical costs for inpatient and outpatient care within 30 days from randomization. PVI will be deemed cost-effective by either 1) reducing 30-day IAA rate without increasing 30-day total societal costs, 2) reducing 30-day total societal costs without increasing 30-day IAA rate, or 3) reducing both 30-day societal costs and IAA rate.
Measured: 30 day follow up
Secondary outcomes (8)
Total patient-reported costs
Patient-reported costs will be assessed using a patient survey, which will be verbally administered by research personnel at each time point specified.
Measured: 30 days, 90 days, 6 months, and 12 months
Health-related quality of life as assessed by the EQ-5D-5L questionnaire
This is a 6 item questionnaire and the first 5 questions are each scored from 1 (no problem) - 5 (unable to), for a maximum score of 25, with a higher number indicating a worse outcome. The 6th question is scored on a Likert scale from 0 (worst health you can imagine) - 100 (best health you can imagine), with a higher score indicating a worse outcome.
Measured: 30 days, 90 days, 6 months, and 12 months
Index admission total hospital costs
Measured: Index admission (variable duration)
90-day total hospital costs
Measured: 90 day follow up
Index admission total length of hospital stay
Measured: Index admission (variable duration)
90-day total length of hospital stay
Measured: 90 day follow up
Number of days of work missed by participant
Measured: 12 months
Postoperative complications
Complications include IAA, clinically relevant IAA, superficial/deep surgical site infection, ED visit, readmission, reoperation, subsequent procedure, or mortality
Measured: 90 days follow up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Nov 2024
- Study start7 Apr 2025
- Primary completion30 Jun 2026 (estimated)
- Study completion31 Mar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Perforated AppendicitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 346 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The University of Texas Health Science Center, Houston
- Sponsor type
- University, hospital or other
- Collaborators
- National Center for Advancing Translational Sciences (NCATS)
- Responsible party
- Principal investigator, Dalya M Ferguson, MD, MS, The University of Texas Health Science Center, Houston
- Investigators
- Dalya Ferguson, MD, MS, Principal investigator, The University of Texas Health Science Center, Houston
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06705842
- Sponsor's protocol ID
- HSC-MS-24-0772
- Other IDs
- 1K12TR004908-01
- Status last verified
- Dec 2025
- First submitted
- 19 Nov 2024
- Last updated
- 11 Dec 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Starting 6 months after study publication, de-identified data and study materials may be made available to researchers on a case-by-case basis.
Study at a glance
From the registry record, last updated by the sponsor on 11 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The APPI-Cost Trial: Cost Assessment of Povidone-Iodine Irrigation for Prevention of Intra-abdominal Abscess in Perforated Appendicitis
- ClinicalTrials.gov ID
- NCT06705842
- Acronym / sponsor ID
- HSC-MS-24-0772
- Conditions
- Perforated Appendicitis
- Keywords
- Perforated Appendicitis, Povidone Iodine, Cost effectiveness, Intra-abdominal abscess, Appendectomy, Implementation science
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 346 participants (estimated)
- Lead sponsor
- The University of Texas Health Science Center, HoustonUniversity, hospital or other
- Collaborators
- National Center for Advancing Translational Sciences (NCATS)
- Study start
- 7 Apr 2025 (actual)
- Primary completion
- 30 Jun 2026 (estimated)
- Study completion
- 31 Mar 2027 (estimated)
- First posted
- 26 Nov 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| PVI | Active comparator | Drug: PVI |
| Usual Care | Active comparator | Drug: Usual Care |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Plan to undergo appendectomy for acute appendicitis
- Enrolled in study preoperatively
- Intraoperative diagnosis of perforated appendicitis
Key exclusion criteria (10 listed)
- Preoperative hemodynamic instability requiring ongoing infusion of vasopressors
- Allergy to iodine
- Uncontrolled hyper- or hypothyroidism
- Renal dysfunction
- Pregnant or breastfeeding
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PVIAfter removal of the appendix from the patient's abdomen and attainment of hemostasis, 10 mL/kg of 1% PVI (up to a maximum of 1,000 mL) will be used to irrigate the pelvis and right upper and lower quadrants. The solution will be left to dwell for 1 minute and then suctioned out | Drug | PVI |
| Usual CareSurgeons may utilize local irrigation with saline if deemed necessary, defined as instillation of a small volume (<100 mL) of liquid followed by aspiration, for the purpose of confirming hemostasis or suctioning thick fluid. Some surgeons may utilize large volume irrigation with saline solution, if that is consistent with their usual practice. Patients in the usual care arm will not receive PVI irrigation. | Drug | Usual Care |
Primary outcome
Cost-effectiveness of PVI relative to usual care
Time frame: 30 day follow up
Cost-effectiveness of PVI irrigation relative to usual care will be assessed as the incremental 30-day total societal costs per percent reduction in IAA rate. The Incremental Cost Effectiveness Ratio (ICER) will be calculated as: (societal costs with PVI irrigation minus societal costs with usual care) divided by (IAA rate with PVI minus IAA rate with usual care). IAA will be defined as an image-confirmed fluid collection deemed to be an IAA by an attending surgeon or radiologist, or an abscess confirmed during percutaneous intervention or reoperation. Societal costs will be defined as patient-reported costs plus medical costs for inpatient and outpatient care within 30 days from randomization. PVI will be deemed cost-effective by either 1) reducing 30-day IAA rate without increasing 30-day total societal costs, 2) reducing 30-day total societal costs without increasing 30-day IAA rate, or 3) reducing both 30-day societal costs and IAA rate.
8 secondary outcomes
Total patient-reported costs
Time frame: 30 days, 90 days, 6 months, and 12 months
Health-related quality of life as assessed by the EQ-5D-5L questionnaire
Time frame: 30 days, 90 days, 6 months, and 12 months
Index admission total hospital costs
Time frame: Index admission (variable duration)
90-day total hospital costs
Time frame: 90 day follow up
Index admission total length of hospital stay
Time frame: Index admission (variable duration)
90-day total length of hospital stay
Time frame: 90 day follow up
Number of days of work missed by participant
Time frame: 12 months
Postoperative complications
Time frame: 90 days follow up
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Dec 2025.
- Individual participant dataSharing planned: Undecided. Starting 6 months after study publication, de-identified data and study materials may be made available to researchers on a case-by-case basis.
Related trials for Perforated Appendicitis
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Piperacillin/Tazobactam Versus Ceftriaxone and Metronidazole for Children With Perforated Appendicitis
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Effect of Probiotic's Consumption on Several Markers in Perforated Appendix Patients With Diffuse Peritonitis
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Use of Antibiotic Irrigation to Decrease Wound Infections in Pediatric Perforated Appendicitis
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Dalya Ferguson, MD, MS principal investigator
The University of Texas Health Science Center, Houston
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing PVI in people with Perforated Appendicitis, run by The University of Texas Health Science Center, Houston at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 11 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Dalya M Ferguson, MD, MS ((713) 566-5098, Dalya.M.Ferguson@uth.tmc.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cost-effectiveness of PVI relative to usual care (time frame: 30 day follow up). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Dec 2025.