An interventional study of Prevena and Prineo in Abdomen Hernia, sponsored by Ohio State University. Recruiting at 1 site in United States. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-03-27.
Sponsored by Ohio State University · Not applicable, Interventional, and Prevention
Randomized controlled trial to compare SSO's in abdominal wall reconstruction patients using Prevena, Prineo, and traditional incisional dressings.
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.
82 studies on the registry are indexed under Hernia, Abdominal; 19 are open to participants now.
This study's planned enrollment of 300 is above the median of 90 across 48 interventional studies indexed under Hernia, Abdominal.
Browse Hernia, Abdominal studies →Ohio State University is the lead sponsor of 663 studies on the registry; 148 are open to participants now.
Of its 67 completed or terminated interventional studies of FDA-regulated products, 49 (73%) have results posted.
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Exclusion Criteria:
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.
Device: Prevena
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.
Device: Prineo
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.
Drug: Traditional
Incisions will be dressed with closed incisional negative pressure wound therapy
Incisions will be dressed with Prineo
Incisions will be dressed with bacitracin/xeroform
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
Average Cost
In USD of postoperative wound care and complications
Time frame: At 6 weeks postoperatively
Average Cost
In USD of postoperative wound care and complications
Time frame: At 3 months postoperatively
Average Cost
In USD of postoperative wound care and complications
Time frame: At 1 year postoperatively
Average pain assessment score: PROMIS Pain Intensity survey
Minimum 3, Maximum 15, higher scores are worse pain/outcomes
Time frame: At 6 weeks postoperatively
Average pain assessment score: PROMIS Pain Intensity survey
Minimum 3, Maximum 15, higher scores are worse pain/outcomes
Time frame: At 3 months postoperatively
Average pain assessment score: PROMIS Pain Intensity survey
Minimum 3, Maximum 15, higher scores are worse pain/outcomes
Time frame: 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.
Time frame: 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.
Time frame: 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.
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
Plan to share: No — Not decided yet
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