The Effects of Post-Operative Interventions on Surgical Site Occurrences in AWR

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.

Study Overview

• Status: Recruiting
• Conditions: Abdomen Hernia
• Intervention / Treatment: Device: Prevena; Device: Prineo; Drug: Traditional

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 Type: Interventional
• Enrollment (Estimated): 300
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Jeffrey Janis, MD; Phone Number: 6143661242; Email: Jeffrey.Janis@osumc.edu
• Study Contact Backup: Name: Benjamin Sarac, MD; Phone Number: 6143661242; Email: Benjamin.Sarac@osumc.edu

Study Locations

• United States
  • Ohio
    • Columbus, Ohio, United States, 43212
      • Recruiting
      • Department of Plastic Surgery
      • Contact: Jeffrey Janis, MD; Phone Number: 614-293-8566; Email: Jeffrey.Janis@osumc.edu
      • Contact: Benjamin Sarac, MD
      • Contact: Austin Seaman, BS

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Single Group Assignment
• Masking: Single

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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: Prevena; Incisions will be dressed with closed incisional negative pressure wound therapy
Experimental: 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.	Device: Prineo; Incisions will be dressed with Prineo
Active Comparator: Standard Dressing; 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 bacitracin/xeroform

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Rate of Infection	At 6 weeks postoperatively
Rate of Seroma	At 6 weeks postoperatively
Rate of Hematoma	At 6 weeks postoperatively
Rate of Dehiscence	At 6 weeks postoperatively
Rate of Skin necrosis	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
Rate of Bulge	At 6 weeks postoperatively

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Average Cost	In USD of postoperative wound care and complications	At 6 weeks postoperatively
Average Cost	In USD of postoperative wound care and complications	At 3 months postoperatively
Average Cost	In USD of postoperative wound care and complications	At 1 year postoperatively
Average pain assessment score: PROMIS Pain Intensity survey	Minimum 3, Maximum 15, higher scores are worse pain/outcomes	At 6 weeks postoperatively
Average pain assessment score: PROMIS Pain Intensity survey	Minimum 3, Maximum 15, higher scores are worse pain/outcomes	At 3 months postoperatively
Average pain assessment score: PROMIS Pain Intensity survey	Minimum 3, Maximum 15, higher scores are worse pain/outcomes	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.	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.	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.	At 3 months postoperatively
Rate of infection		At 3 months postoperatively
Rate of infection		At 1 year postoperatively
Rate of Seroma		At 3 months postoperatively
Rate of Seroma		At 1 year postoperatively
Rate of Hematoma		At 1 year postoperatively
Rate of Hematoma		At 3 months postoperatively
Rate of Dehiscence		At 3 months postoperatively
Rate of Dehiscence		At 1 year postoperatively
Rate of Skin Necrosis		At 3 months postoperatively
Rate of Skin Necrosis		At 1 year postoperatively
Rate of Enterocutaneous fistula		At 3 months postoperatively
Rate of Enterocutaneous fistula		At 1 year postoperatively
Rate of Mesh infection		At 3 months postoperatively
Rate of Mesh infection		At 1 year postoperatively
Rate of Hernia Recurrence		At 3 months postoperatively
Rate of Hernia Recurrence		At 1 year postoperatively
Rate of Bulge		At 3 months postoperatively
Rate of Bulge		At 1 year postoperatively

Collaborators and Investigators

• Sponsor: Ohio State University
• Investigators: Principal Investigator: Jeffrey E Janis, MD, Ohio State University

Study record dates

Study Major Dates

• Study Start (Actual): September 17, 2021
• Primary Completion (Estimated): May 1, 2028
• Study Completion (Estimated): May 1, 2028

Study Registration Dates

• First Submitted: May 18, 2021
• First Submitted That Met QC Criteria: May 24, 2021
• First Posted (Actual): May 28, 2021

Study Record Updates

• Last Update Posted (Actual): March 27, 2025
• Last Update Submitted That Met QC Criteria: March 24, 2025
• Last Verified: March 1, 2025

More Information

Terms related to this study

• Keywords: Infection; seroma; hematoma; skin necrosis; EC fistula; Mesh infection; Hernia recurrence; Bulge; Prevena; Prineo; Abdominal wall reconstruction; SSO; dressings
• Additional Relevant MeSH Terms: Pathological Conditions, Anatomical; Hernia
• Other Study ID Numbers: 2021H0061

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Not decided yet

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No