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RecruitingNot ApplicableNCT04906408

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

Sponsor

Ohio State University

Enrollment

300 participants

Start Date

Sep 17, 2021

Study Type

INTERVENTIONAL

Conditions

Abdomen Hernia

Summary

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

Eligibility

Min Age: 18 Years

Inclusion Criteria3

  • 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 Criteria5

  • 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

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Interventions

DEVICEPrevena

Incisions will be dressed with closed incisional negative pressure wound therapy

DEVICEPrineo

Incisions will be dressed with Prineo

DRUGTraditional

Incisions will be dressed with bacitracin/xeroform

Locations(1)

Department of Plastic Surgery

Columbus, Ohio, United States

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NCT04906408