Recruiting

Observational Study

Sponsor:

Ohio State University

Code:

NCT04906408

Conditions

Abdomen Hernia

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

Interventions

Prevena

Prineo

Traditional

Study Details

Brief summary:

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

Conditions

Abdomen Hernia

Study ID

NCT04906408

Start date

Sep 17, 2021

Status verified date

Mar, 2025

Completion date

May 1, 2028

Anticipated

Primary completion date

May 1, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

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 Design

Enrollment

300 participants

Anticipated

Allocation

Randomized

Intervention Model

Single group

Primary purpose

Prevention

Interventions and Outcome Measures

Arms

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.

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.

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.

Interventions

Prevena

Incisions will be dressed with closed incisional negative pressure wound therapy

Prineo

Incisions will be dressed with Prineo

Traditional

Incisions will be dressed with bacitracin/xeroform

Primary outcome measure

  • Rate of Infection [ Time Frame: At 6 weeks postoperatively ]
  • Rate of Seroma [ Time Frame: At 6 weeks postoperatively ]
  • Rate of Hematoma [ Time Frame: At 6 weeks postoperatively ]
  • Rate of Dehiscence [ Time Frame: At 6 weeks postoperatively ]
  • Rate of Skin necrosis [ Time Frame: At 6 weeks postoperatively ]
  • Rate of Enterocutaneous fistula [ Time Frame: At 6 weeks postoperatively ]
  • Rate of Mesh infection [ Time Frame: At 6 weeks postoperatively ]
  • Rate of Hernia recurrence [ Time Frame: At 6 weeks postoperatively ]
  • Rate of Bulge [ Time Frame: At 6 weeks postoperatively ]

Central Contacts and Locations

Central contacts

Jeffrey Janis, MD

6143661242Jeffrey.Janis@osumc.edu

Benjamin Sarac, MD

6143661242Benjamin.Sarac@osumc.edu

Locations

Department of Plastic Surgery

Recruiting

Columbus, Ohio, United States, 43212

Contacts

Jeffrey Janis, MD

614-293-8566Jeffrey.Janis@osumc.edu

More Information

Sponsor

Ohio State University

Last update posted

Mar 27, 2025

Last verified

Mar, 2025

Keywords

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

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Ohio State University on 2025-03-27.