The Effects of Post-Operative Interventions on Surgical Site Occurrences in AWR
- Conditions
- Abdomen Hernia
- Interventions
- Device: PrineoDevice: PrevenaDrug: Traditional
- Registration Number
- NCT04906408
- Lead Sponsor
- Ohio State University
- Brief Summary
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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 300
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Prineo 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. Prevena 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. Standard Dressing Traditional 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.
- Primary Outcome Measures
Name Time Method Rate of Hematoma At 6 weeks postoperatively Rate of Skin necrosis At 6 weeks postoperatively Rate of Bulge At 6 weeks postoperatively Rate of Seroma At 6 weeks postoperatively Rate of Infection At 6 weeks postoperatively Rate of Dehiscence At 6 weeks postoperatively Rate of Enterocutaneous fistula At 6 weeks postoperatively Rate of Mesh infection At 6 weeks postoperatively Rate of Hernia recurrence At 6 weeks postoperatively
- Secondary Outcome Measures
Name Time Method Average Cost At 1 year postoperatively In USD of postoperative wound care and complications
Average scar assessment score: POSAS (Patient and Observer Scar) Assessment Scale) 2.0 survey At 3 months postoperatively Provider score: Minimum 7, Maximum 70, higher scores are worse appearance/outcome.
Patient score: Minimum 7, Maximum 70, higher scores are worse appearance/outcome.Rate of Enterocutaneous fistula At 1 year postoperatively Rate of Dehiscence At 1 year postoperatively Rate of infection At 1 year postoperatively Rate of Seroma At 1 year postoperatively Rate of Hematoma At 3 months postoperatively Rate of Mesh infection At 1 year postoperatively Average pain assessment score: PROMIS Pain Intensity survey At 1 year postoperatively Minimum 3, Maximum 15, higher scores are worse pain/outcomes
Rate of Skin Necrosis At 1 year postoperatively Rate of Hernia Recurrence At 1 year postoperatively Rate of Bulge At 1 year postoperatively
Trial Locations
- Locations (1)
Department of Plastic Surgery
🇺🇸Columbus, Ohio, United States