Clinical trial NCT04906408: The Effects of Post-Operative Interventions on Surgical Site Occurrences in AWR
Official title: The Effects of Post-Operative Interventions on Surgical Site Occurrences in Abdominal Wall Reconstructions: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Abdomen Hernia
Keywords: Infection
seroma
hematoma
skin necrosis
EC fistula
Mesh infection
Hernia recurrence
Bulge
Prevena
Prineo
Abdominal wall reconstruction
SSO
dressings
Lead sponsor: Ohio State University
Sponsor class: OTHER
First posted: 2021-05-28
Enrollment: 300
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Intervention model description: Partially blinded prospective, randomized-controlled trial
Primary purpose: PREVENTION

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.

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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

Primary outcomes:
measure: Rate of Infection
timeFrame: At 6 weeks postoperatively
measure: Rate of Seroma
timeFrame: At 6 weeks postoperatively
measure: Rate of Hematoma
timeFrame: At 6 weeks postoperatively
measure: Rate of Dehiscence
timeFrame: At 6 weeks postoperatively
measure: Rate of Skin necrosis
timeFrame: At 6 weeks postoperatively
measure: Rate of Enterocutaneous fistula
timeFrame: At 6 weeks postoperatively
measure: Rate of Mesh infection
timeFrame: At 6 weeks postoperatively
measure: Rate of Hernia recurrence
timeFrame: At 6 weeks postoperatively
measure: Rate of Bulge
timeFrame: At 6 weeks postoperatively
Secondary outcomes:
measure: Average Cost
timeFrame: At 6 weeks postoperatively
measure: Average Cost
timeFrame: At 3 months postoperatively
measure: Average Cost
timeFrame: At 1 year postoperatively
measure: Average pain assessment score: PROMIS Pain Intensity survey
timeFrame: At 6 weeks postoperatively
measure: Average pain assessment score: PROMIS Pain Intensity survey
timeFrame: At 3 months postoperatively
measure: Average pain assessment score: PROMIS Pain Intensity survey
timeFrame: At 1 year postoperatively
measure: Average scar assessment score: POSAS (Patient and Observer Scar) Assessment Scale) 2.0 survey
timeFrame: At 1 year postoperatively
measure: Average scar assessment score: POSAS (Patient and Observer Scar) Assessment Scale) 2.0 survey
timeFrame: At 6 weeks postoperatively
measure: Average scar assessment score: POSAS (Patient and Observer Scar) Assessment Scale) 2.0 survey
timeFrame: At 3 months postoperatively
measure: Rate of infection
timeFrame: At 3 months postoperatively
measure: Rate of infection
timeFrame: At 1 year postoperatively
measure: Rate of Seroma
timeFrame: At 3 months postoperatively
measure: Rate of Seroma
timeFrame: At 1 year postoperatively
measure: Rate of Hematoma
timeFrame: At 1 year postoperatively
measure: Rate of Hematoma
timeFrame: At 3 months postoperatively
measure: Rate of Dehiscence
timeFrame: At 3 months postoperatively
measure: Rate of Dehiscence
timeFrame: At 1 year postoperatively
measure: Rate of Skin Necrosis
timeFrame: At 3 months postoperatively
measure: Rate of Skin Necrosis
timeFrame: At 1 year postoperatively
measure: Rate of Enterocutaneous fistula
timeFrame: At 3 months postoperatively
measure: Rate of Enterocutaneous fistula
timeFrame: At 1 year postoperatively
measure: Rate of Mesh infection
timeFrame: At 3 months postoperatively
measure: Rate of Mesh infection
timeFrame: At 1 year postoperatively
measure: Rate of Hernia Recurrence
timeFrame: At 3 months postoperatively
measure: Rate of Hernia Recurrence
timeFrame: At 1 year postoperatively
measure: Rate of Bulge
timeFrame: At 3 months postoperatively
measure: Rate of Bulge
timeFrame: At 1 year postoperatively
Other outcomes:
Locations:
city: Columbus
country: United States
facility: Department of Plastic Surgery
state: Ohio
Study officials:
affiliation: Ohio State University
name: Jeffrey E Janis, MD
role: PRINCIPAL_INVESTIGATOR
References: