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

NCT04906408 | Recruiting FDA Device

• 1 other identifier: 2021H0061
• Study Type: interventional
• Target: 300
• Locations: 1 country
• Sites: 1

Brief Summary

Randomized controlled trial to compare SSO's in abdominal wall reconstruction patients using Prevena, Prineo, and traditional incisional dressings.

Conditions

Abdomen Hernia

Keywords

Infection; seroma; hematoma; skin necrosis; EC fistula; Mesh infection; Hernia recurrence; Bulge; Prevena; Prineo; Abdominal wall reconstruction; SSO; dressings

Outcome Measures

Primary Outcomes (9)

• 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 Outcomes (27)

• Average Cost

  At 6 weeks postoperatively

• Average Cost

  At 3 months postoperatively

• Average Cost

  At 1 year postoperatively

• Average pain assessment score: PROMIS Pain Intensity survey

  At 6 weeks postoperatively

• Average pain assessment score: PROMIS Pain Intensity survey

  At 3 months postoperatively

Study Arms (3)

Prevena

EXPERIMENTAL

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

Prineo

EXPERIMENTAL

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

Standard Dressing

ACTIVE COMPARATOR

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

Interventions

Prevena DEVICE

Incisions will be dressed with closed incisional negative pressure wound therapy

Prevena

Prineo DEVICE

Incisions will be dressed with Prineo

Prineo

Traditional DRUG

Incisions will be dressed with bacitracin/xeroform

Standard Dressing

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Ohio State University: lead

Study Sites (1)

Department of Plastic Surgery

Columbus, Ohio, 43212, United States

RECRUITING

MeSH Terms

Conditions

Hernia, Abdominal; Infections; Seroma; Hematoma; Necrosis

Condition Hierarchy (Ancestors)

Hernia; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms; Inflammation; Pathologic Processes; Hemorrhage

Study Officials

• Jeffrey E Janis, MD

  Ohio State University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jeffrey Janis, MD

CONTACT

6143661242; Jeffrey.Janis@osumc.edu

Benjamin Sarac, MD

CONTACT

6143661242; Benjamin.Sarac@osumc.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Masking Details: Patient will not know what they received until randomization after consent process, surgeon will find out the day of surgery
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: Partially blinded prospective, randomized-controlled trial

Study Record Dates

• First Submitted: May 18, 2021
• First Posted: May 28, 2021
• Study Start: September 17, 2021
• Primary Completion (Estimated): May 1, 2028
• Study Completion (Estimated): May 1, 2028
• Last Updated: March 27, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)