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Hernia Abdominal WallPhase 4PRETOXNCT07220382

Preoperative BOTOX® Injection for Large Ventral Hernia Repair

A Phase 4 study testing OnabotulinumtoxinA Injection, OnabotulinumtoxinA and 0.9 % Normal Saline in people with Hernia Abdominal Wall and Botox Injection, run by The Cleveland Clinic at 1 site in United States.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

This study is for adults who need open surgery to repair a very large abdominal (ventral) hernia. This study tests whether a one-time, image-guided injection of a medicine commonly known as "BOTOX®" (onabotulinumtoxinA) into the side abdominal muscles 3-7 weeks before surgery helps surgeons close the abdominal wall… Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
OnabotulinumtoxinA Injection, OnabotulinumtoxinA and 0.9 % Normal Saline
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
188 participants
Where
1 siteUnited States
Study dates
3 Nov 2025to 15 Dec 2029
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

  • Adult (greater than or equal to 18 years of age)
  • Candidate for elective open repair of ventral hernia
  • Preoperative imaging demonstrating either:
  • ventral hernia defect width of at lest 15 cm; AND/OR,
  • Tanaka volume ratio of at least 25%
  • Planned elective hernia repair in an open fashion via a midline laparotomy with posterior component separation and transversus abdominis release

Who cannot join

  • Emergent cases
  • Pregnancy and/or breastfeeding at time of intramuscular injection
  • Inability to provide informed consent
  • Inability to receive either study intervention (i.e. allergy to local anesthetics utilized for intervention administration, allergy and/or contraindication to any botulinum toxin, inability to attend outpatient administration of study intervention, inability to conform to safety check schedule)
  • Known congenital or acquired neuromuscular disorder
  • Presence of stoma
Show all 10Show fewer
  • Current infection at time of intramuscular injection
  • Flank hernias s defined by EHS L1-L4
  • BMI > 45 kg/m^2
  • Diaphragmatic hemiparesis or chronic obstructive pulmonary disease (COPD) with chronic oxygen dependence

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Lucas R Beffa, MD contact

216-445-5975

beffal@ccf.org

Vishal Rajesh, MD, MPH contact

216-904-8880

rajeshv@ccf.org

United States1 site, 1 recruiting

  • Cleveland Clinic Main Campus

    Cleveland, Ohio, 44195

    Lucas R Beffa, MD, 216-445-5975, beffal@ccf.org

    Vishal Rajesh, MD, MPH, 216-904-8880, rajeshv@ccf.org

    Recruiting

Other trials in United States

About this study

Official title: PREoperative Targeted OnabotulinumtoXina Injection for Abdominal Wall Reconstruction: A Randomized, Double-Blind, Placebo-Controlled Trial

This study is for adults who need open surgery to repair a very large abdominal (ventral) hernia. This study tests whether a one-time, image-guided injection of a medicine commonly known as "BOTOX®" (onabotulinumtoxinA) into the side abdominal muscles 3-7 weeks before surgery helps surgeons close the abdominal wall fully at the end of the operation. Closing the muscle and tissue layers ("primary fascial closure") is linked to fewer problems after surgery and better quality of life.

Participants will be randomly assigned (like a coin flip) to receive either the BOTOX® medicine or a saltwater (placebo) injection. Neither patients nor the care team will know which one was given. All participants will still have their planned hernia repair in the standard way that we repair patients who are not part of the study. The study will track whether the abdomen can be closed without leaving a gap, and investigators will also look at recovery, complications, time in the ICU or on a ventilator, length of stay, pain, and quality-of-life scores. Most information will be collected during participants' hospital stay, but the investigators will continue to see how participants are doing up to 2 years after surgery. Short phone check-ins will occur before surgery, and after surgery follow-up happens around 30 days, 90 days, 1 year, and 2 years.

Possible risks from the injection include temporary muscle weakness, trouble swallowing or breathing, pain or infection at the injection site, and (if CT is used for guidance) a small amount of radiation exposure. Surgery itself carries the usual risks (pain, bleeding, wound problems). Benefits are not guaranteed, but the injection may make closure easier and recovery smoother. About 188 people will take part at Cleveland Clinic.

Read the detailed description

Background and Rationale:

Massive ventral hernias (pre-op axial width ≥15 cm and/or Tanaka volume ratio >25%) seldom achieve primary fascial closure (PFC) and are associated with higher respiratory morbidity, intensive care unit (ICU) utilization, post-operative pain, hospital length of stay (LOS), cost, and recurrence. Spasticity/fibrosis of the external oblique-internal oblique-transversus abdominis (EO/IO/TA) complex likely limits lateral abdominal wall compliance and impedes midline medialization. Pre-operative, image-guided onabotulinumtoxinA (BOTOX®) has been proposed to elongate the lateral wall, enlarge the functional abdominal domain, reduce closure pressures, and thereby increase the primary fascial closure (PFC) rate. Prior institutional data show ~77% PFC in this population without pre-op toxin, whereas retrospective series suggest ~95% with toxin utilization, motivating a definitive randomized trial.

Design:

Single-center, randomized, double-blind, placebo-controlled superiority trial. Randomization uses pre-generated block allocation (statistician-generated). Analyses will be intention-to-treat (ITT), with a parallel per-protocol (PP) analyses limited to participants who receive the assigned injection and undergo AWR within 21-48 days post-injection. A single interim analysis is planned at 50% completion of primary endpoint. Intention-to-treat (ITT) is primary method of analysis; however, a per-protocol (PP) analysis will also be conducted as this supports causal inference among adherent participants. An independent DMC will review interim results and advise on continuation/early stopping.

Interventions:

Fully described in 'Arms and Interventions' section. Participants will either receive image-guided injections of BOTOX® at six sites on the lateral abdominal wall (three sites per side) with a total of 300 units give (2 u / cc concentration; 25 cc at each site); or, participants will receive the same volume of a 0.9% saline solution (25 cc at each site).

End Points and Outcomes:

Fully described in the 'Outcomes Measures' section. Primary endpoint is primary fascial closure (PFC), the successful closure of hernia defect at the conclusion of the case. Additional secondary outcomes regarding clinical course and patient-reported outcomes will be captured at 30 days, 90 days, 1 year, and 2 years.

Exploratory outcomes include cost and healthcare utilization information, as well as comparison of physiological parameters between treatment groups.

Data Stewardship:

Primary data capture occurs in the ACHQC registry, supplemented by an institutional REDCap database for variables not routinely captured (e.g., physiologic measures) in the registry.

Being tested
OnabotulinumtoxinA Injection, Saline (placebo) Injection, OnabotulinumtoxinA, 0.9 % Normal Saline, Open Ventral Hernia Repair
Keywords
BOTOX, Ventral Hernia, Abdominal Wall Reconstruction, OnabotulinumtoxinA, Preoperative BOTOX, Primary Fascial Closure, Fascial Bridging, Transversus Abdominis Release, Posterior Component Separation
Medical subject headings
Hernia, Abdominal, Hernia, Incisional Hernia, Hernia, Ventral

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • OnabotulinumtoxinA InjectionProcedure or surgery

    Also called BOTOX® Injection

    A total of 300 units of onabotulinumtoxinA will be reconstituted 150 cc of injectable 0.9% NaCl (for a final concentration of 2 units / cc). Each side of the abdominal wall will receive a total 75 cc distributed across three injection sites (six injection sites total per patient). At each injection site, the muscle bodies of the transversus abdominis, internal oblique, and external oblique will receive an equivalent volume of product under ultrasonic or radiographic visualization.

  • Saline (placebo) InjectionProcedure or surgery

    150 cc of injectable 0.9% NaCl will be prepared. Each side of the abdominal wall will receive a total 75 cc distributed across three injection sites. At each injection site, the muscle bodies of the transversus abdominis, internal oblique, and external oblique will receive an equivalent volume of product under ultrasonic or radiographic visualization.

  • OnabotulinumtoxinADrug

    Also called BOTOX®

    300 units of onabotulinumtoxinA will be prepared and administered as described in: "Procedure/Surgery: OnabotulinumtoxinA Injections"

  • 0.9 % Normal SalineDrug

    Also called Saline, Salt Water, Placebo, Normal Saline

    150cc of normal saline will be prepared and administered as described in: "Procedure/Surgery: Saline (placebo) Injection".

  • Open Ventral Hernia RepairProcedure or surgery

    Also called Abdominal Wall Reconstruction, Posterior Component Separation

    Open abdominal wall reconstruction will be conducted in our standard fashion for the repair of very large hernias. The surgery is the same for patients who are not in the study. Surgeons will be blinded to the study arm of participant patients.

Study groups in NCT07220382
Study groupRoleWhat they receive
OnabotulinumtoxinA GroupExperimentalThese patients will receive image-guided botulinumtoxin injections as described 21-48 days prior to open ventral hernia repair.
Receives: Procedure: OnabotulinumtoxinA Injection; Drug: OnabotulinumtoxinA; Procedure: Open Ventral Hernia Repair
Placebo GroupPlacebo comparatorThese patients will receive image-guided saline (placebo) injections as described 21-48 days prior to open ventral hernia repair.
Receives: Procedure: Saline (placebo) Injection; Drug: 0.9 % Normal Saline; Procedure: Open Ventral Hernia Repair

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Primary Fascial Closure (PFC) at conclusion of Hernia Surgery (Yes / No, determined by surgeon)

    Primary fascial closure (PFC) is the successful closure of the hernia. It will be defined in a binary, categorical manner as: "Yes" (fascial closed) or "No" (fascia not closed and bridging mesh required). To be considered "Yes" for PFC, the midline anterior fascia must be completely re-approximated via absorbable running or figure-of-eight sutures. If any segment of the anterior fascia cannot be approximated and closed, the patient will require anterior bridging and this would be considered a failure of PFC.

    Surgeons will decide if the fascia can be closed or if it cannot be closed by their expertise and discretion. No prespecified criteria have been established which dictate operative decision-making. The study team will record an outcome of "Yes" for PFC if the fascia is successfully closed by the surgeon via an eligible technique as previously described.

    Measured: This will be measured (recorded) on the day of the hernia repair surgery, which will be 21 to 48 days after receiving your BOTOX injection.

Secondary outcomes (42)

  1. 30-Day Surgical Site Occurrence (SSO) - Proportion of Participants (%)

    SSOs will be abstracted from the clinical record in a prospective fashion. They are defined as wound-related problems at or near the incision within 30 days of surgery (e.g., infection, fluid or blood collections, wound separation, or skin edge death). These will be measured on an individual level basis, and will be captured via patient interview and chart review within the specified timeframe. Aggregate calculation for a population: numerator = participants with ≥1 SSO; denominator = all randomized participants who underwent surgery; unit = participants (%).

    Measured: Approximately 30 to 45 days after hernia repair surgery, which would be approximately 2 to 3 months after injection procedure.

  2. 30-Day Surgical Site Infection (SSI) - Proportion of Participants (%)

    Any incisional or organ/space infection within 30 days, identified by treating teams. These will be measured on an individual level basis, and will be captured via patient interview, clinician-report, and/or chart review within the specified timeframe. Defined via any antibiotic and/or antimicrobial treatment of an infection at the surgical site. Positive culture or proof of pathogen not needed. Aggregate calculation for a population: numerator = participants with ≥1 SSO; denominator = all randomized participants who underwent surgery; unit = participants (%).

    Measured: Approximately 30 to 45 days after hernia repair surgery, which would be approximately 2 to 3 months after injection procedure.

  3. 30-Day SSOPI (Surgical Site Occurrence Requiring Procedural Intervention) - Proportion of Participants (%)

    These are SSO events (as described in 30-Day SSO outcome) that required a bedside/clinic or OR procedure (e.g., aspiration, drainage, debridement) within 30 days. Cumulative SSOPIs will be calculated for each group. Additionally, aggregate calculation for a study group: numerator = participants with ≥1 SSOPI; denominator = all randomized participants who underwent surgery; unit = participants (%).

    Measured: Approximately 30 to 45 days after hernia repair surgery, which would be approximately 2 to 3 months after injection procedure.

  4. 30-Day Readmission - Proportion of Participants (%)

    Any inpatient hospital readmission within 30 days of index surgery. "How measured": EHR review/REDCap; unit = participants (%).

    Measured: Approximately 30 to 45 days after hernia repair surgery, which would be approximately 2 to 3 months after injection procedure.

  5. 30-Day Reoperation - Proportion of Participants (%)

    Any return to the operating room related to the index surgery within 30 days. "How measured": EHR/REDCap; unit = participants (%).

    Measured: Approximately 30 to 45 days after hernia repair surgery, which would be approximately 2 to 3 months after injection procedure.

  6. 30-Day Hospital Length of Stay - Days

    Days from operation to hospital discharge. "How measured": EHR discharge date minus surgery date; unit = days.

    Measured: Approximately 30 to 45 days after hernia repair surgery, which would be approximately 2 to 3 months after injection procedure.

  7. 30-Day ICU Admission - Proportion of Participants (%)

    Any ICU care during the index stay or within 30 days (planned or unplanned). "How measured": EHR/REDCap; unit = participants (%).

    Measured: Approximately 30 to 45 days after hernia repair surgery, which would be approximately 2 to 3 months after injection procedure.

  8. Duration of Mechanical Ventilation (Index Hospitalization) - Hours

    Total ventilator time during and after surgery until final extubation during the index stay. Will be sub-divided as during surgery and after surgery. "How measured": anesthesia/intensive care record; unit = hours (may also be displayed as days:hours)

    Measured: Approximately 30 to 45 days after hernia repair surgery, which would be approximately 2 to 3 months after injection procedure.

  9. 30-Day Myocardial Infarction (MI) - Proportion of Participants (%)

    MI within 30 days per treating clinician diagnosis. "How measured": medical record review, patient interview, and/or clinical diagnosis. Unit = participants (%).

    Measured: Approximately 30 to 45 days after hernia repair surgery, which would be approximately 2 to 3 months after injection procedure.

  10. 30-Day Pneumonia - Proportion of Participants (%)

    Clinically diagnosed pneumonia within 30 days. "How measured": patient interview, medical record review, or clinical diagnosis. Unit = participants (%).

    Measured: Approximately 30 to 45 days after hernia repair surgery, which would be approximately 2 to 3 months after injection procedure.

  11. 30-Day Renal Failure/Acute Kidney Injury (AKI) - Proportion of Participants (%)

    Acute kidney injury/failure within 30 days. "How measured": clinician diagnosis, medical record review, and/or KDIGO Guidelines. Unit = participants (%).

    Measured: Approximately 30 to 45 days after hernia repair surgery, which would be approximately 2 to 3 months after injection procedure.

  12. 30-Day Post-operative Ileus - Proportion of Participants (%)

    Ileus requiring clinical management within 30 days. Defined as placement of an nasogastric tube or clinical diagnosis by surgeon based on intolerance of oral intake or delayed return of bowel function. "How measured": medical record review or clinician diagnosis. Unit = participants (%).

    Measured: Approximately 30 to 45 days after hernia repair surgery, which would be approximately 2 to 3 months after injection procedure.

  13. 30-Day Patient-Reported Outcomes Measurement Information System (PROMIS®) Pain Intensity Short Form 3a - T-Score (Raw Response score range: 0-10, Higher = Worse Pain)

    Three-item pain intensity questionnaire. "How measured": PROMIS-3a administered at follow-up; raw sum (3-15) converted to T-score (mean 50, SD 10); higher scores = more pain (worse). Unit = T-score.

    Measured: Approximately 30 to 45 days after hernia repair surgery, which would be approximately 2 to 3 months after injection procedure.

  14. 30-Day Hernia-Related Quality-of-Life Survey (HerQLes) - Score (0-100; Higher = Better QoL)

    12-item hernia-specific QoL instrument. "How measured": HerQLes administered at follow-up; score transformed 0-100, higher = better function/less disability. Unit = total score (0-100).

    Measured: Approximately 30 to 45 days after hernia repair surgery, which would be approximately 2 to 3 months after injection procedure.

  15. 30-Day Complication Severity (Clavien-Dindo) - Distribution of Highest Grade (I-V)

    Highest complication grade based on the Clavien-Dindo classification system per participant within 30 days. "How measured": graded in REDCap from clinical documentation; unit = participants in each grade (%). Minimum = I, maximum = V; higher grades = worse.

    Measured: Approximately 30 to 45 days after hernia repair surgery, which would be approximately 2 to 3 months after injection procedure.

  16. 90-Day SSO - Proportion of Participants (%)

    SSOs will be abstracted from the clinical record in a prospective fashion. They are defined as wound-related problems at or near the incision within 90 days of surgery (e.g., infection, fluid or blood collections, wound separation, or skin edge death). These will be measured on an individual level basis, and will be captured via patient interview and chart review within the specified timeframe. Aggregate calculation for a population: numerator = participants with ≥1 SSO; denominator = all randomized participants who underwent surgery; unit = participants (%).

    Measured: Approximately 3 months after hernia repair surgery, which would be about 4 to 5 months after injection procedure.

  17. 90-Day SSI - Proportion of Participants (%)

    Any incisional or organ/space infection within 90 days, identified by treating teams. These will be measured on an individual level basis, and will be captured via patient interview, clinician-report, and/or chart review within the specified timeframe. Defined via any antibiotic and/or antimicrobial treatment of an infection at the surgical site. Positive culture or proof of pathogen not needed. Aggregate calculation for a population: numerator = participants with ≥1 SSO; denominator = all randomized participants who underwent surgery; unit = participants (%).

    Measured: Approximately 3 months after hernia repair surgery, which would be about 4 to 5 months after injection procedure.

  18. 90-Day SSOPI - Proportion of Participants (%)

    These are SSO events (as described in 30-Day SSO outcome) that required a bedside/clinic or OR procedure (e.g., aspiration, drainage, debridement) within 90 days. Cumulative SSOPIs will be calculated for each group. Additionally, aggregate calculation for a study group: numerator = participants with ≥1 SSOPI; denominator = all randomized participants who underwent surgery; unit = participants (%).

    Measured: Approximately 3 months after hernia repair surgery, which would be about 4 to 5 months after injection procedure.

  19. 90-Day Complication Severity (Clavien-Dindo) - Distribution of Highest Grade (I-V)

    Highest complication grade based on the Clavien-Dindo classification system per participant within 90 days. "How measured": graded in REDCap from clinical documentation; unit = participants in each grade (%). Minimum = I, maximum = V; higher grades = worse.

    Measured: Approximately 3 months after hernia repair surgery, which would be about 4 to 5 months after injection procedure.

  20. 90-Day Comprehensive Complication Index (CCI) Score at 90 Days - Score

    Comprehensive Complication Index® score, which is a weighted score based on the number of complications in each Clavien-Dindo group within 90 postoperative days. "How measured": the individuals CCI score at 90-days, as calculated via https://www.cci-calculator.com/.

    Measured: Approximately 3 months after hernia repair surgery, which would be about 4 to 5 months after injection procedure.

  21. 90-Day Readmission - Proportion of Participants (%)

    Any inpatient hospital readmission within 30 days of index surgery. "How measured": EHR review/REDCap; unit = participants (%).

    Measured: Approximately 3 months after hernia repair surgery, which would be about 4 to 5 months after injection procedure.

  22. 90-Day Reoperation - Proportion of Participants (%)

    Any return to the operating room related to the index surgery within 90 days. "How measured": patient interview, medical record review, surgeon report; unit = participants (%).

    Measured: Approximately 3 months after hernia repair surgery, which would be about 4 to 5 months after injection procedure.

  23. 90-Day Patient-Reported Outcomes Measurement Information System (PROMIS®) Pain Intensity Short Form 3a - T-Score (Raw Response score range: 0-10, Higher = Worse Pain)

    Three-item pain intensity questionnaire. "How measured": PROMIS-3a administered at follow-up; raw sum (3-15) converted to T-score (mean 50, SD 10); higher scores = more pain (worse). Unit = T-score.

    Measured: Approximately 3 months after hernia repair surgery, which would be about 4 to 5 months after injection procedure.

  24. 90-Day Hernia-Related Quality-of-Life Survey (HerQLes) - Score (0-100; Higher = Better QoL)

    12-item hernia-specific QoL instrument. "How measured": HerQLes administered at follow-up; score transformed 0-100, higher = better function/less disability. Unit = total score (0-100).

    Measured: Approximately 3 months after hernia repair surgery, which would be about 4 to 5 months after injection procedure.

  25. 1-Year Surgical Site Occurrence (SSO) - Proportion of Participants (%)

    SSOs will be abstracted from the clinical record in a prospective fashion. They are defined as wound-related problems at or near the incision within 1 year of surgery (e.g., infection, fluid or blood collections, wound separation, or skin edge death). These will be measured on an individual level basis, and will be captured via patient interview and chart review within the specified timeframe. Aggregate calculation for a population: numerator = participants with ≥1 SSO; denominator = all randomized participants who underwent surgery; unit = participants (%).

    Measured: Approximately 1 year after hernia repair surgery

  26. 1-Year Surgical Site Infection (SSI) - Proportion of Participants (%)

    Any incisional or organ/space infection within 1 year, identified by treating teams. These will be measured on an individual level basis, and will be captured via patient interview, clinician-report, and/or chart review within the specified timeframe. Defined via any antibiotic and/or antimicrobial treatment of an infection at the surgical site. Positive culture or proof of pathogen not needed. Aggregate calculation for a population: numerator = participants with ≥1 SSO; denominator = all randomized participants who underwent surgery; unit = participants (%).

    Measured: Approximately 1 year after hernia repair surgery

  27. 1-Year SSOPI - Proportion of Participants (%)

    These are SSO events (as described in 30-Day SSO outcome) that required a bedside/clinic or OR procedure (e.g., aspiration, drainage, debridement) within 1 year. Cumulative SSOPIs will be calculated for each group. Additionally, aggregate calculation for a study group: numerator = participants with ≥1 SSOPI; denominator = all randomized participants who underwent surgery; unit = participants (%).

    Measured: Approximately 1 year after hernia repair surgery

  28. 1-Year Reoperation

    Any return to the operating room related to the index surgery within 1 year. "How measured": patient interview, medical record review, surgeon report; unit = participants (%).

    Measured: Approximately 1 year after hernia repair surgery

  29. 1-Year Reoperation for Hernia Recurrence

    Any return to the operating room related repair of a hernia within 7 cm of the hernia repaired in the original surgery within 1 year. "How measured": patient interview, medical record review, surgeon report; unit = participants (%).

    Measured: Approximately 1 year after hernia repair surgery

  30. 1-Year Hernia Recurrence (Clinical)

    A recurrence after hernia repair is defined as a new hernia detected within 7cm of the original repair. The hernia must be determined via imaging (ultrasound, computed tomography scan, or magnetic resonance imaging scan) or the documented physical exam of a licensed practitioner. Determined as within 1 year of the hernia repair surgery.

    Measured: Approximately 1 year after hernia repair surgery

  31. 1-Year Hernia Recurrence (Patient-Reported)

    Patient self-reported concern for recurrence based on response to the the question, "Do you feel or see a bulge?" on the Ventral Hernia Recurrence Inventory (VHRI) questionnaire. Asked at 1 year.

    Measured: Approximately 1 year after hernia repair surgery

  32. 1-Year Patient-Reported Outcomes Measurement Information System (PROMIS®) Pain Intensity Short Form 3a - T-Score (Raw Response score range: 0-10, Higher = Worse Pain)

    Three-item pain intensity questionnaire. "How measured": PROMIS-3a administered at follow-up; raw sum (3-15) converted to T-score (mean 50, SD 10); higher scores = more pain (worse). Unit = T-score.

    Measured: Approximately 1 year after hernia repair surgery

  33. 1-Year Hernia-Related Quality-of-Life Survey (HerQLes) - Score (0-100; Higher = Better QoL)

    12-item hernia-specific QoL instrument. "How measured": HerQLes administered at follow-up; score transformed 0-100, higher = better function/less disability. Unit = total score (0-100).

    Measured: Approximately 1 year after hernia repair surgery

  34. 2-Year Surgical Site Occurrence (SSO) - Proportion of Participants (%)

    SSOs will be abstracted from the clinical record in a prospective fashion. They are defined as wound-related problems at or near the incision within 2 years of surgery (e.g., infection, fluid or blood collections, wound separation, or skin edge death). These will be measured on an individual level basis, and will be captured via patient interview and chart review within the specified timeframe. Aggregate calculation for a population: numerator = participants with ≥1 SSO; denominator = all randomized participants who underwent surgery; unit = participants (%).

    Measured: Approximately 2 years after hernia repair surgery

  35. 2-Year Surgical Site Infection (SSI) - Proportion of Participants (%)

    Any incisional or organ/space infection within 2 years, identified by treating teams. These will be measured on an individual level basis, and will be captured via patient interview, clinician-report, and/or chart review within the specified timeframe. Defined via any antibiotic and/or antimicrobial treatment of an infection at the surgical site. Positive culture or proof of pathogen not needed. Aggregate calculation for a population: numerator = participants with ≥1 SSO; denominator = all randomized participants who underwent surgery; unit = participants (%).

    Measured: Approximately 2 years after hernia repair surgery

  36. 2-Year SSOPI - Proportion of Participants (%)

    These are SSO events (as described in 30-Day SSO outcome) that required a bedside/clinic or OR procedure (e.g., aspiration, drainage, debridement) within 2 years. Cumulative SSOPIs will be calculated for each group. Additionally, aggregate calculation for a study group: numerator = participants with ≥1 SSOPI; denominator = all randomized participants who underwent surgery; unit = participants (%).

    Measured: Approximately 2 years after hernia repair surgery

  37. 2-Year Reoperation

    Any return to the operating room related to the index surgery within 2 years. "How measured": patient interview, medical record review, surgeon report; unit = participants (%).

    Measured: Approximately 2 years after hernia repair surgery

  38. 2-Year Reoperation for Hernia Recurrence

    Any return to the operating room related repair of a hernia within 7 cm of the hernia repaired in the original surgery within 2 years. "How measured": patient interview, medical record review, surgeon report; unit = participants (%).

    Measured: Approximately 2 years after hernia repair surgery

  39. 2-Year Hernia Recurrence (Clinical)

    A recurrence after hernia repair is defined as a new hernia detected within 7cm of the original repair. The hernia must be determined via imaging (ultrasound, computed tomography scan, or magnetic resonance imaging scan) or the documented physical exam of a licensed practitioner. Determined as within 2 years of the hernia repair surgery.

    Measured: Approximately 2 years after hernia repair surgery

  40. 2-Year Hernia Recurrence (Patient-Reported)

    Patient self-reported concern for recurrence based on response to the the question, "Do you feel or see a bulge?" on the Ventral Hernia Recurrence Inventory (VHRI) questionnaire. Asked at 2 years.

    Measured: Approximately 2 years after hernia repair surgery

  41. 2-Year Patient-Reported Outcomes Measurement Information System (PROMIS®) Pain Intensity Short Form 3a - T-Score (Raw Response score range: 0-10, Higher = Worse Pain)

    Three-item pain intensity questionnaire. "How measured": PROMIS-3a administered at follow-up; raw sum (3-15) converted to T-score (mean 50, SD 10); higher scores = more pain (worse). Unit = T-score.

    Measured: Approximately 2 year after hernia repair surgery

  42. 2-Year Hernia-Related Quality-of-Life Survey (HerQLes) - Score (0-100; Higher = Better QoL)

    12-item hernia-specific QoL instrument. "How measured": HerQLes administered at follow-up; score transformed 0-100, higher = better function/less disability. Unit = total score (0-100).

    Measured: Approximately 2 year after hernia repair surgery

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted23 Oct 2025
  2. Study start3 Nov 2025
  3. Primary completion15 Dec 2027 (estimated)
  4. Study completion15 Dec 2029 (estimated)

Resources

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
Triple blind
Who is masked
Participant, Care provider, Outcomes assessor
Enrolment
188 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07220382
Sponsor's protocol ID
25-824
Acronym
PRETOX
Status last verified
Oct 2026
First submitted
17 Oct 2025
Last updated
26 Oct 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No: Patients will not be consented for the sharing of individual participant data outside of the Cleveland Clinic.

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing OnabotulinumtoxinA Injection, OnabotulinumtoxinA and 0.9 % Normal Saline in people with Hernia Abdominal Wall and Botox Injection, run by The Cleveland Clinic 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 6 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 26 Oct 2026. 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. Some participants in this study may receive a placebo. 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 Lucas R Beffa, MD (216-445-5975, beffal@ccf.org), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Primary Fascial Closure (PFC) at conclusion of Hernia Surgery (Yes / No, determined by surgeon) (time frame: This will be measured (recorded) on the day of the hernia repair surgery, which will be 21 to 48 days after receiving your BOTOX injection.). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07220382.

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 26 Oct 2026.

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