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

Primary Purpose

Abdomen Hernia

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Prevena
Prineo
Traditional
Sponsored by
Ohio State University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Abdomen Hernia focused on measuring Infection, seroma, hematoma, skin necrosis, EC fistula, Mesh infection, Hernia recurrence, Bulge, Prevena, Prineo, Abdominal wall reconstruction, SSO, dressings

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Department of Plastic SurgeryRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Active Comparator

Arm Label

Prevena

Prineo

Standard Dressing

Arm Description

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.

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.

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.

Outcomes

Primary Outcome Measures

Rate of Infection
Rate of Seroma
Rate of Hematoma
Rate of Dehiscence
Rate of Skin necrosis
Rate of Enterocutaneous fistula
Rate of Mesh infection
Rate of Hernia recurrence
Rate of Bulge

Secondary Outcome Measures

Average Cost
In USD of postoperative wound care and complications
Average Cost
In USD of postoperative wound care and complications
Average Cost
In USD of postoperative wound care and complications
Average pain assessment score: PROMIS Pain Intensity survey
Minimum 3, Maximum 15, higher scores are worse pain/outcomes
Average pain assessment score: PROMIS Pain Intensity survey
Minimum 3, Maximum 15, higher scores are worse pain/outcomes
Average pain assessment score: PROMIS Pain Intensity survey
Minimum 3, Maximum 15, higher scores are worse pain/outcomes
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.
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.
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.
Rate of infection
Rate of infection
Rate of Seroma
Rate of Seroma
Rate of Hematoma
Rate of Hematoma
Rate of Dehiscence
Rate of Dehiscence
Rate of Skin Necrosis
Rate of Skin Necrosis
Rate of Enterocutaneous fistula
Rate of Enterocutaneous fistula
Rate of Mesh infection
Rate of Mesh infection
Rate of Hernia Recurrence
Rate of Hernia Recurrence
Rate of Bulge
Rate of Bulge

Full Information

First Posted
May 18, 2021
Last Updated
January 18, 2023
Sponsor
Ohio State University
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1. Study Identification

Unique Protocol Identification Number
NCT04906408
Brief Title
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

2. Study Status

Record Verification Date
January 2023
Overall Recruitment Status
Recruiting
Study Start Date
September 17, 2021 (Actual)
Primary Completion Date
May 1, 2025 (Anticipated)
Study Completion Date
May 1, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Ohio State University

4. Oversight

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
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Abdomen Hernia
Keywords
Infection, seroma, hematoma, skin necrosis, EC fistula, Mesh infection, Hernia recurrence, Bulge, Prevena, Prineo, Abdominal wall reconstruction, SSO, dressings

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
Partially blinded prospective, randomized-controlled trial
Masking
Investigator
Masking Description
Patient will not know what they received until randomization after consent process, surgeon will find out the day of surgery
Allocation
Randomized
Enrollment
300 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Prevena
Arm Type
Experimental
Arm Description
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.
Arm Title
Prineo
Arm Type
Experimental
Arm Description
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.
Arm Title
Standard Dressing
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
Prevena
Intervention Description
Incisions will be dressed with closed incisional negative pressure wound therapy
Intervention Type
Device
Intervention Name(s)
Prineo
Intervention Description
Incisions will be dressed with Prineo
Intervention Type
Drug
Intervention Name(s)
Traditional
Intervention Description
Incisions will be dressed with bacitracin/xeroform
Primary Outcome Measure Information:
Title
Rate of Infection
Time Frame
At 6 weeks postoperatively
Title
Rate of Seroma
Time Frame
At 6 weeks postoperatively
Title
Rate of Hematoma
Time Frame
At 6 weeks postoperatively
Title
Rate of Dehiscence
Time Frame
At 6 weeks postoperatively
Title
Rate of Skin necrosis
Time Frame
At 6 weeks postoperatively
Title
Rate of Enterocutaneous fistula
Time Frame
At 6 weeks postoperatively
Title
Rate of Mesh infection
Time Frame
At 6 weeks postoperatively
Title
Rate of Hernia recurrence
Time Frame
At 6 weeks postoperatively
Title
Rate of Bulge
Time Frame
At 6 weeks postoperatively
Secondary Outcome Measure Information:
Title
Average Cost
Description
In USD of postoperative wound care and complications
Time Frame
At 6 weeks postoperatively
Title
Average Cost
Description
In USD of postoperative wound care and complications
Time Frame
At 3 months postoperatively
Title
Average Cost
Description
In USD of postoperative wound care and complications
Time Frame
At 1 year postoperatively
Title
Average pain assessment score: PROMIS Pain Intensity survey
Description
Minimum 3, Maximum 15, higher scores are worse pain/outcomes
Time Frame
At 6 weeks postoperatively
Title
Average pain assessment score: PROMIS Pain Intensity survey
Description
Minimum 3, Maximum 15, higher scores are worse pain/outcomes
Time Frame
At 3 months postoperatively
Title
Average pain assessment score: PROMIS Pain Intensity survey
Description
Minimum 3, Maximum 15, higher scores are worse pain/outcomes
Time Frame
At 1 year postoperatively
Title
Average scar assessment score: POSAS (Patient and Observer Scar) Assessment Scale) 2.0 survey
Description
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
Title
Average scar assessment score: POSAS (Patient and Observer Scar) Assessment Scale) 2.0 survey
Description
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
Title
Average scar assessment score: POSAS (Patient and Observer Scar) Assessment Scale) 2.0 survey
Description
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
Title
Rate of infection
Time Frame
At 3 months postoperatively
Title
Rate of infection
Time Frame
At 1 year postoperatively
Title
Rate of Seroma
Time Frame
At 3 months postoperatively
Title
Rate of Seroma
Time Frame
At 1 year postoperatively
Title
Rate of Hematoma
Time Frame
At 1 year postoperatively
Title
Rate of Hematoma
Time Frame
At 3 months postoperatively
Title
Rate of Dehiscence
Time Frame
At 3 months postoperatively
Title
Rate of Dehiscence
Time Frame
At 1 year postoperatively
Title
Rate of Skin Necrosis
Time Frame
At 3 months postoperatively
Title
Rate of Skin Necrosis
Time Frame
At 1 year postoperatively
Title
Rate of Enterocutaneous fistula
Time Frame
At 3 months postoperatively
Title
Rate of Enterocutaneous fistula
Time Frame
At 1 year postoperatively
Title
Rate of Mesh infection
Time Frame
At 3 months postoperatively
Title
Rate of Mesh infection
Time Frame
At 1 year postoperatively
Title
Rate of Hernia Recurrence
Time Frame
At 3 months postoperatively
Title
Rate of Hernia Recurrence
Time Frame
At 1 year postoperatively
Title
Rate of Bulge
Time Frame
At 3 months postoperatively
Title
Rate of Bulge
Time Frame
At 1 year postoperatively

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jeffrey Janis, MD
Phone
6143661242
Email
Jeffrey.Janis@osumc.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Benjamin Sarac, MD
Phone
6143661242
Email
Benjamin.Sarac@osumc.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jeffrey E Janis, MD
Organizational Affiliation
Ohio State University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of Plastic Surgery
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43212
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jeffrey Janis, MD
Phone
614-293-8566
Email
Jeffrey.Janis@osumc.edu
First Name & Middle Initial & Last Name & Degree
Benjamin Sarac, MD
First Name & Middle Initial & Last Name & Degree
Austin Seaman, BS

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
Not decided yet

Learn more about this trial

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

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