Abdomen HerniaNCT04906408
The Effects of Post-Operative Interventions on Surgical Site Occurrences in AWR
A study testing Prevena, Prineo and Traditional in people with Abdomen Hernia, run by Ohio State University at 1 site in United States.
Trial summary
Randomized controlled trial to compare SSO's in abdominal wall reconstruction patients using Prevena, Prineo, and traditional incisional dressings. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Abdomen Hernia
- What is being tested?
- Prevena, Prineo and Traditional
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 300 participants
- Where
- 1 siteUnited States
- Study dates
- 17 Sep 2021to 1 May 2028
- Phase
- Interventional
- 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Age > 18
- Patients presenting for elective ventral hernia repair
- Patients deemed to be good surgical candidates, with no active life-threatening cardiac disease, pulmonary disease, renal disease, hematologic disease -Patients who will have a closed incision following the surgery
Who cannot join
- Known allergy to any material used in any wound treatment (Prevena- Acrylic adhesive or silver, Prineo- Dermabond glue, Standard- Bacitracin, Xeroform, surgical tape) -Active smokers (within the past 4 weeks) presenting for elective hernia repair
- Patients with active life-threatening cardiac disease, pulmonary disease, renal disease, hematologic disease presenting for elective ventral hernia repair
- Patients presenting for emergent ventral hernia repair (in the setting of bowel strangulation, necrosis, penetrating trauma) as it will be difficult to consent those patients for the study preoperatively
- Patients with severe systemic sepsis
- Patients with frank purulence in the wound -Patients with an open wound following surgery -Patients undergoing a panniculectomy
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
Department of Plastic Surgery
Columbus, Ohio, 43212
Jeffrey Janis, MD, 614-293-8566, Jeffrey.Janis@osumc.edu
Benjamin Sarac, MD
About this study
Official title: The Effects of Post-Operative Interventions on Surgical Site Occurrences in Abdominal Wall Reconstructions: A Randomized Controlled Trial
Randomized controlled trial to compare SSO's in abdominal wall reconstruction patients using Prevena, Prineo, and traditional incisional dressings.
Read the detailed description
Surgical site occurrences (SSOs) are a common complication of complex abdominal wall reconstruction (AWR), with rates ranging from 29-63.6%. Contributors to the high rates include: 1) comorbidities in this patient population such as; obesity, diabetes, smoking, and poor nutrition; 2) the need for complex surgical techniques including component separation, the use of mesh, skin resection, and the creation of adjacent skin flaps; 3) the possibility of contamination as a result of enterotomies or infected mesh from a previous procedure.
Any measures that can be taken to reduce the rates of surgical site occurrences are worthy of investigation, as they would help to decrease the morbidity and mortality of these procedures, while also potentially decreasing the overall cost associated with them. One measure of particular interest is what post-operative intervention, or wound dressing, is used. Many options exist. Those widely used include Prevena™, a vacuum assisted therapy that goes directly over the closed incision to assist with closure. This system works by placing a small piece of foam over the closed incision and then applying a vacuum over the foam. This allows the vacuum to apply uniformed pressure over the incision. It is thought that this vacuum creates negative pressure that helps to prevent contamination, hold the incision together, and remove fluid and infectious materials from the incision site. Another commonly used product is Prineo™, a self-adhering mesh that utilizes Dermabond™ glue technology that goes directly over the closed incision to assist with closure. The glue dries quickly over the incision and mesh, creating a barrier that is flexible but also resistant to contamination. While blocking potential contaminants such as water and bacteria from getting in, it allows water vapor to escape, while promoting a moist wound healing environment. There is also the traditional wound dressing which consists of Bacitracin antibiotics on a xeroform gauze, covered with a standard abdominal pad and tape.
Prevena™ has been widely studied in plastic surgery, specifically in AWR for large ventral hernias and for other complex abdominal reconstructions and is associated with reductions in SSOs from 22-51%. While there is strong evidence to support the use of Prevena in this patient population, there remains skepticism due to the lack of randomized, prospective studies to support its use. Prineo™ has not been studied as in depth, but multiple studies have shown it to be as efficacious as standard wound dressings in regard to wound healing, if not better.
There are currently no published reports comparing the rates of SSOs between these three therapies. This information is important to collect due to their potential abilities to reduce the rates of SSOs. Finding which decreases this rate the most can help guide decision making in our practice and potentially across the world.
When a patient with a ventral hernia or an abdominal wall tumor presents to the senior author for evaluation for abdominal wall reconstruction, a full history and physical examination will be performed. Patients who satisfy the study inclusion and exclusion criteria will be offered the opportunity to participate in the study. If they agree to participate, informed consent and HIPAA forms will be filled out and signed.
Patients will then be randomized to group A (Prevena™) or group B (Prineo™) or group C (Standard wound dressing) using a random number generator made in Microsoft Excel. They will not be told which group they are in, and only the principal investigator, co-investigators and operating room staff will be aware of which post-operative intervention is being used until after the surgery.
The patients will be asked to fill out 1 survey preoperatively: PROMIS Pain Intensity survey
They will then undergo surgery and will be followed within one week for wound dressing removal if needed, then at 6 weeks, 3 months, and 1 year and as needed. They will be evaluated for ventral hernia recurrence, bulge, or other SSOs throughout the follow-up period.
They will be asked to fill out the PROMIS Pain Intensity survey and POSAS 2.0 survey at 6 weeks, 3 months, and 1 year.
- Conditions
- Abdomen Hernia
- Being tested
- Prevena, Prineo, Traditional
- Keywords
- Infection, seroma, hematoma, skin necrosis, EC fistula, Mesh infection, Hernia recurrence, Bulge, Prevena, Prineo, Abdominal wall reconstruction, SSO, dressings
- Medical subject headings
- Hernia, Abdominal, Infections, Seroma, Hematoma, Necrosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PrevenaDevice
Incisions will be dressed with closed incisional negative pressure wound therapy
PrineoDevice
Incisions will be dressed with Prineo
TraditionalDrug
Incisions will be dressed with bacitracin/xeroform
| Study group | Role | What they receive |
|---|---|---|
| Prevena | Experimental | Patients will then be randomized to group A (Prevena™) or group B (Prineo™) or group C (Standard wound dressing) using a random number generator made in Microsoft Excel. They will be made aware of which group they are in after the consent and randomization process, in order for proper post-operative teaching during the pre-operative clinic visit. The principal investigator, co-investigators and operating room staff will be aware of which post-operative intervention is being used on the day of surgery. Receives: Device: Prevena |
| Prineo | Experimental | Patients will then be randomized to group A (Prevena™) or group B (Prineo™) or group C (Standard wound dressing) using a random number generator made in Microsoft Excel. They will be made aware of which group they are in after the consent and randomization process, in order for proper post-operative teaching during the pre-operative clinic visit. The principal investigator, co-investigators and operating room staff will be aware of which post-operative intervention is being used on the day of surgery. Receives: Device: Prineo |
| Standard Dressing | Active comparator | Patients will then be randomized to group A (Prevena™) or group B (Prineo™) or group C (Standard wound dressing) using a random number generator made in Microsoft Excel. They will be made aware of which group they are in after the consent and randomization process, in order for proper post-operative teaching during the pre-operative clinic visit. The principal investigator, co-investigators and operating room staff will be aware of which post-operative intervention is being used on the day of surgery. Receives: Drug: Traditional |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of Infection
Measured: At 6 weeks postoperatively
Rate of Seroma
Measured: At 6 weeks postoperatively
Rate of Hematoma
Measured: At 6 weeks postoperatively
Rate of Dehiscence
Measured: At 6 weeks postoperatively
Rate of Skin necrosis
Measured: At 6 weeks postoperatively
Rate of Enterocutaneous fistula
Measured: At 6 weeks postoperatively
Rate of Mesh infection
Measured: At 6 weeks postoperatively
Rate of Hernia recurrence
Measured: At 6 weeks postoperatively
Rate of Bulge
Measured: At 6 weeks postoperatively
Secondary outcomes (27)
Average Cost
In USD of postoperative wound care and complications
Measured: At 6 weeks postoperatively
Average Cost
In USD of postoperative wound care and complications
Measured: At 3 months postoperatively
Average Cost
In USD of postoperative wound care and complications
Measured: At 1 year postoperatively
Average pain assessment score: PROMIS Pain Intensity survey
Minimum 3, Maximum 15, higher scores are worse pain/outcomes
Measured: At 6 weeks postoperatively
Average pain assessment score: PROMIS Pain Intensity survey
Minimum 3, Maximum 15, higher scores are worse pain/outcomes
Measured: At 3 months postoperatively
Average pain assessment score: PROMIS Pain Intensity survey
Minimum 3, Maximum 15, higher scores are worse pain/outcomes
Measured: At 1 year postoperatively
Average scar assessment score: POSAS (Patient and Observer Scar) Assessment Scale) 2.0 survey
Provider score: Minimum 7, Maximum 70, higher scores are worse appearance/outcome.
Patient score: Minimum 7, Maximum 70, higher scores are worse appearance/outcome.
Measured: At 1 year postoperatively
Average scar assessment score: POSAS (Patient and Observer Scar) Assessment Scale) 2.0 survey
Provider score: Minimum 7, Maximum 70, higher scores are worse appearance/outcome.
Patient score: Minimum 7, Maximum 70, higher scores are worse appearance/outcome.
Measured: At 6 weeks postoperatively
Average scar assessment score: POSAS (Patient and Observer Scar) Assessment Scale) 2.0 survey
Provider score: Minimum 7, Maximum 70, higher scores are worse appearance/outcome.
Patient score: Minimum 7, Maximum 70, higher scores are worse appearance/outcome.
Measured: At 3 months postoperatively
Rate of infection
Measured: At 3 months postoperatively
Rate of infection
Measured: At 1 year postoperatively
Rate of Seroma
Measured: At 3 months postoperatively
Rate of Seroma
Measured: At 1 year postoperatively
Rate of Hematoma
Measured: At 1 year postoperatively
Rate of Hematoma
Measured: At 3 months postoperatively
Rate of Dehiscence
Measured: At 3 months postoperatively
Rate of Dehiscence
Measured: At 1 year postoperatively
Rate of Skin Necrosis
Measured: At 3 months postoperatively
Rate of Skin Necrosis
Measured: At 1 year postoperatively
Rate of Enterocutaneous fistula
Measured: At 3 months postoperatively
Rate of Enterocutaneous fistula
Measured: At 1 year postoperatively
Rate of Mesh infection
Measured: At 3 months postoperatively
Rate of Mesh infection
Measured: At 1 year postoperatively
Rate of Hernia Recurrence
Measured: At 3 months postoperatively
Rate of Hernia Recurrence
Measured: At 1 year postoperatively
Rate of Bulge
Measured: At 3 months postoperatively
Rate of Bulge
Measured: At 1 year postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 May 2021
- Study start17 Sep 2021
- Primary completion1 May 2028 (estimated)
- Study completion1 May 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Abdomen HerniaStudies of the same condition, open and under way.
- More trials run by Ohio State UniversityThe sponsor's other registered studies.
- 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 N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Single group
- Model description
- Partially blinded prospective, randomized-controlled trial
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ohio State University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jeffrey Janis, Ohio State University
- Investigators
- Jeffrey E Janis, MD, Principal investigator, Ohio State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04906408
- Sponsor's protocol ID
- 2021H0061
- Status last verified
- Mar 2025
- First submitted
- 18 May 2021
- Last updated
- 27 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No: Not decided yet
Study at a glance
From the registry record, last updated by the sponsor on 27 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Post-Operative Interventions on Surgical Site Occurrences in Abdominal Wall Reconstructions: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT04906408
- Acronym / sponsor ID
- 2021H0061
- Conditions
- Abdomen Hernia
- Keywords
- Infection, seroma, hematoma, skin necrosis, EC fistula, Mesh infection, Hernia recurrence, Bulge
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Ohio State UniversityUniversity, hospital or other
- Study start
- 17 Sep 2021 (actual)
- Primary completion
- 1 May 2028 (estimated)
- Study completion
- 1 May 2028 (estimated)
- First posted
- 28 May 2021 (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.
Randomized controlled trial to compare SSO's in abdominal wall reconstruction patients using Prevena, Prineo, and traditional incisional dressings.
Detailed description
Surgical site occurrences (SSOs) are a common complication of complex abdominal wall reconstruction (AWR), with rates ranging from 29-63.6%. Contributors to the high rates include: 1) comorbidities in this patient population such as; obesity, diabetes, smoking, and poor nutrition; 2) the need for complex surgical techniques including component separation, the use of mesh, skin resection, and the creation of adjacent skin flaps; 3) the possibility of contamination as a result of enterotomies or infected mesh from a previous procedure.
Any measures that can be taken to reduce the rates of surgical site occurrences are worthy of investigation, as they would help to decrease the morbidity and mortality of these procedures, while also potentially decreasing the overall cost associated with them. One measure of particular interest is what post-operative intervention, or wound dressing, is used. Many options exist. Those widely used include Prevena™, a vacuum assisted therapy that goes directly over the closed incision to assist with closure. This system works by placing a small piece of foam over the closed incision and then applying a vacuum over the foam. This allows the vacuum to apply uniformed pressure over the incision. It is thought that this vacuum creates negative pressure that helps to prevent contamination, hold the incision together, and remove fluid and infectious materials from the incision site. Another commonly used product is Prineo™, a self-adhering mesh that utilizes Dermabond™ glue technology that goes directly over the closed incision to assist with closure. The glue dries quickly over the incision and mesh, creating a barrier that is flexible but also resistant to contamination. While blocking potential contaminants such as water and bacteria from getting in, it allows water vapor to escape, while promoting a moist wound healing environment. There is also the traditional wound dressing which consists of Bacitracin antibiotics on a xeroform gauze, covered with a standard abdominal pad and tape.
Prevena™ has been widely studied in plastic surgery, specifically in AWR for large ventral hernias and for other complex abdominal reconstructions and is associated with reductions in SSOs from 22-51%. While there is strong evidence to support the use of Prevena in this patient population, there remains skepticism due to the lack of randomized, prospective studies to support its use. Prineo™ has not been studied as in depth, but multiple studies have shown it to be as efficacious as standard wound dressings in regard to wound healing, if not better.
There are currently no published reports comparing the rates of SSOs between these three therapies. This information is important to collect due to their potential abilities to reduce the rates of SSOs. Finding which decreases this rate the most can help guide decision making in our practice and potentially across the world.
When a patient with a ventral hernia or an abdominal wall tumor presents to the senior author for evaluation for abdominal wall reconstruction, a full history and physical examination will be performed. Patients who satisfy the study inclusion and exclusion criteria will be offered the opportunity to participate in the study. If they agree to participate, informed consent and HIPAA forms will be filled out and signed.
Patients will then be randomized to group A (Prevena™) or group B (Prineo™) or group C (Standard wound dressing) using a random number generator made in Microsoft Excel. They will not be told which group they are in, and only the principal investigator, co-investigators and operating room staff will be aware of which post-operative intervention is being used until after the surgery.
The patients will be asked to fill out 1 survey preoperatively: PROMIS Pain Intensity survey
They will then undergo surgery and will be followed within one week for wound dressing removal if needed, then at 6 weeks, 3 months, and 1 year and as needed. They will be evaluated for ventral hernia recurrence, bulge, or other SSOs throughout the follow-up period.
They will be asked to fill out the PROMIS Pain Intensity survey and POSAS 2.0 survey at 6 weeks, 3 months, and 1 year.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind (investigator)
- Number of arms
- 3
- Model description
- Partially blinded prospective, randomized-controlled trial
| Arm | Type | Receives |
|---|---|---|
| Prevena | Experimental | Device: PrevenaPatients will then be randomized to group A (Prevena™) or group B (Prineo™) or group C (Standard wound dressing) using a random number generator made in Microsoft Excel. They will be made aware of which group they are in after the consent and randomization process, in order for proper post-operative teaching during the pre-operative clinic visit. The principal investigator, co-investigators and operating room staff will be aware of which post-operative intervention is being used on the day of surgery. |
| Prineo | Experimental | Device: PrineoPatients will then be randomized to group A (Prevena™) or group B (Prineo™) or group C (Standard wound dressing) using a random number generator made in Microsoft Excel. They will be made aware of which group they are in after the consent and randomization process, in order for proper post-operative teaching during the pre-operative clinic visit. The principal investigator, co-investigators and operating room staff will be aware of which post-operative intervention is being used on the day of surgery. |
| Standard Dressing | Active comparator | Drug: TraditionalPatients will then be randomized to group A (Prevena™) or group B (Prineo™) or group C (Standard wound dressing) using a random number generator made in Microsoft Excel. They will be made aware of which group they are in after the consent and randomization process, in order for proper post-operative teaching during the pre-operative clinic visit. The principal investigator, co-investigators and operating room staff will be aware of which post-operative intervention is being used on the day of surgery. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Age > 18
- Patients presenting for elective ventral hernia repair
- Patients deemed to be good surgical candidates, with no active life-threatening cardiac disease, pulmonary disease, renal disease, hematologic disease -Patients who will have a closed incision following the surgery
Key exclusion criteria (5 listed)
- Known allergy to any material used in any wound treatment (Prevena- Acrylic adhesive or silver, Prineo- Dermabond glue, Standard- Bacitracin, Xeroform, surgical tape) -Active smokers (within the past 4 weeks) presenting for elective hernia repair
- Patients with active life-threatening cardiac disease, pulmonary disease, renal disease, hematologic disease presenting for elective ventral hernia repair
- Patients presenting for emergent ventral hernia repair (in the setting of bowel strangulation, necrosis, penetrating trauma) as it will be difficult to consent those patients for the study preoperatively
- Patients with severe systemic sepsis
- Patients with frank purulence in the wound -Patients with an open wound following surgery -Patients undergoing a panniculectomy
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 |
|---|---|---|
| PrevenaIncisions will be dressed with closed incisional negative pressure wound therapy | Device | Prevena |
| PrineoIncisions will be dressed with Prineo | Device | Prineo |
| TraditionalIncisions will be dressed with bacitracin/xeroform | Drug | Standard Dressing |
Primary outcome
Rate of Infection
Time frame: At 6 weeks postoperatively
Rate of Seroma
Time frame: At 6 weeks postoperatively
Rate of Hematoma
Time frame: At 6 weeks postoperatively
Rate of Dehiscence
Time frame: At 6 weeks postoperatively
Rate of Skin necrosis
Time frame: At 6 weeks postoperatively
Rate of Enterocutaneous fistula
Time frame: At 6 weeks postoperatively
Rate of Mesh infection
Time frame: At 6 weeks postoperatively
Rate of Hernia recurrence
Time frame: At 6 weeks postoperatively
Rate of Bulge
Time frame: At 6 weeks postoperatively
27 secondary outcomes
Average Cost
Time frame: At 6 weeks postoperatively
Average Cost
Time frame: At 3 months postoperatively
Average Cost
Time frame: At 1 year postoperatively
Average pain assessment score: PROMIS Pain Intensity survey
Time frame: At 6 weeks postoperatively
Average pain assessment score: PROMIS Pain Intensity survey
Time frame: At 3 months postoperatively
Average pain assessment score: PROMIS Pain Intensity survey
Time frame: At 1 year postoperatively
Average scar assessment score: POSAS (Patient and Observer Scar) Assessment Scale) 2.0 survey
Time frame: At 1 year postoperatively
Average scar assessment score: POSAS (Patient and Observer Scar) Assessment Scale) 2.0 survey
Time frame: At 6 weeks postoperatively
Average scar assessment score: POSAS (Patient and Observer Scar) Assessment Scale) 2.0 survey
Time frame: At 3 months postoperatively
Rate of infection
Time frame: At 3 months postoperatively
Rate of infection
Time frame: At 1 year postoperatively
Rate of Seroma
Time frame: At 3 months postoperatively
Rate of Seroma
Time frame: At 1 year postoperatively
Rate of Hematoma
Time frame: At 1 year postoperatively
Rate of Hematoma
Time frame: At 3 months postoperatively
Rate of Dehiscence
Time frame: At 3 months postoperatively
Rate of Dehiscence
Time frame: At 1 year postoperatively
Rate of Skin Necrosis
Time frame: At 3 months postoperatively
Rate of Skin Necrosis
Time frame: At 1 year postoperatively
Rate of Enterocutaneous fistula
Time frame: At 3 months postoperatively
Rate of Enterocutaneous fistula
Time frame: At 1 year postoperatively
Rate of Mesh infection
Time frame: At 3 months postoperatively
Rate of Mesh infection
Time frame: At 1 year postoperatively
Rate of Hernia Recurrence
Time frame: At 3 months postoperatively
Rate of Hernia Recurrence
Time frame: At 1 year postoperatively
Rate of Bulge
Time frame: At 3 months postoperatively
Rate of Bulge
Time frame: At 1 year postoperatively
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 27 Mar 2025.
- Individual participant dataSharing planned: No. Not decided yet
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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.
Jeffrey E Janis, MD principal investigator
Ohio State University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Prevena, Prineo and Traditional in people with Abdomen Hernia, run by Ohio State University 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 5 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 27 Mar 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.
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 Jeffrey Janis, MD (6143661242, Jeffrey.Janis@osumc.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rate of Infection (time frame: At 6 weeks postoperatively). The study lists 9 primary outcomes in all. 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 27 Mar 2025.