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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.

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

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.

Jeffrey Janis, MD contact

6143661242

Jeffrey.Janis@osumc.edu

Benjamin Sarac, MD contact

6143661242

Benjamin.Sarac@osumc.edu

United States1 site, 1 recruiting
  • Department of Plastic Surgery

    Columbus, Ohio, 43212

    Jeffrey Janis, MD, 614-293-8566, Jeffrey.Janis@osumc.edu

    Benjamin Sarac, MD

    Recruiting

Other trials in United States

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 groups in NCT04906408
Study groupRoleWhat they receive
PrevenaExperimentalPatients 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
PrineoExperimentalPatients 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 DressingActive comparatorPatients 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.

  1. Rate of Infection

    Measured: At 6 weeks postoperatively

  2. Rate of Seroma

    Measured: At 6 weeks postoperatively

  3. Rate of Hematoma

    Measured: At 6 weeks postoperatively

  4. Rate of Dehiscence

    Measured: At 6 weeks postoperatively

  5. Rate of Skin necrosis

    Measured: At 6 weeks postoperatively

  6. Rate of Enterocutaneous fistula

    Measured: At 6 weeks postoperatively

  7. Rate of Mesh infection

    Measured: At 6 weeks postoperatively

  8. Rate of Hernia recurrence

    Measured: At 6 weeks postoperatively

  9. Rate of Bulge

    Measured: At 6 weeks postoperatively

Secondary outcomes (27)
  1. Average Cost

    In USD of postoperative wound care and complications

    Measured: At 6 weeks postoperatively

  2. Average Cost

    In USD of postoperative wound care and complications

    Measured: At 3 months postoperatively

  3. Average Cost

    In USD of postoperative wound care and complications

    Measured: At 1 year postoperatively

  4. Average pain assessment score: PROMIS Pain Intensity survey

    Minimum 3, Maximum 15, higher scores are worse pain/outcomes

    Measured: At 6 weeks postoperatively

  5. Average pain assessment score: PROMIS Pain Intensity survey

    Minimum 3, Maximum 15, higher scores are worse pain/outcomes

    Measured: At 3 months postoperatively

  6. Average pain assessment score: PROMIS Pain Intensity survey

    Minimum 3, Maximum 15, higher scores are worse pain/outcomes

    Measured: At 1 year postoperatively

  7. 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

  8. 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

  9. 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

  10. Rate of infection

    Measured: At 3 months postoperatively

  11. Rate of infection

    Measured: At 1 year postoperatively

  12. Rate of Seroma

    Measured: At 3 months postoperatively

  13. Rate of Seroma

    Measured: At 1 year postoperatively

  14. Rate of Hematoma

    Measured: At 1 year postoperatively

  15. Rate of Hematoma

    Measured: At 3 months postoperatively

  16. Rate of Dehiscence

    Measured: At 3 months postoperatively

  17. Rate of Dehiscence

    Measured: At 1 year postoperatively

  18. Rate of Skin Necrosis

    Measured: At 3 months postoperatively

  19. Rate of Skin Necrosis

    Measured: At 1 year postoperatively

  20. Rate of Enterocutaneous fistula

    Measured: At 3 months postoperatively

  21. Rate of Enterocutaneous fistula

    Measured: At 1 year postoperatively

  22. Rate of Mesh infection

    Measured: At 3 months postoperatively

  23. Rate of Mesh infection

    Measured: At 1 year postoperatively

  24. Rate of Hernia Recurrence

    Measured: At 3 months postoperatively

  25. Rate of Hernia Recurrence

    Measured: At 1 year postoperatively

  26. Rate of Bulge

    Measured: At 3 months postoperatively

  27. 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.

  1. First posted28 May 2021
  2. Study start17 Sep 2021
  3. Primary completion1 May 2028 (estimated)
  4. Study completion1 May 2028 (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 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)
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

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.

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