RECRUITING

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

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Conditions

Abdomen HerniaInfectionseromahematomaskin necrosisEC fistulaMesh infectionHernia recurrenceBulgePrevenaPrineoAbdominal wall reconstructionSSOdressings

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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

Official Title

The Effects of Post-Operative Interventions on Surgical Site Occurrences in Abdominal Wall Reconstructions: A Randomized Controlled Trial

Quick Facts

Study Start:2021-09-17
Study Completion:2026-05-01
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT04906408

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:Yes
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Age \> 18
  2. * Patients presenting for elective ventral hernia repair
  3. * 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
  1. * 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
  2. * Patients with active life-threatening cardiac disease, pulmonary disease, renal disease, hematologic disease presenting for elective ventral hernia repair
  3. * 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
  4. * Patients with severe systemic sepsis
  5. * Patients with frank purulence in the wound -Patients with an open wound following surgery -Patients undergoing a panniculectomy

Contacts and Locations

Study Contact

Jeffrey Janis, MD
CONTACT
6143661242
Jeffrey.Janis@osumc.edu
Benjamin Sarac, MD
CONTACT
6143661242
Benjamin.Sarac@osumc.edu

Principal Investigator

Jeffrey E Janis, MD
PRINCIPAL_INVESTIGATOR
Ohio State University

Study Locations (Sites)

Department of Plastic Surgery
Columbus, Ohio, 43212
United States

Collaborators and Investigators

Sponsor: Ohio State University

  • Jeffrey E Janis, MD, PRINCIPAL_INVESTIGATOR, Ohio State University

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2021-09-17
Study Completion Date2026-05-01

Study Record Updates

Study Start Date2021-09-17
Study Completion Date2026-05-01

Terms related to this study

Keywords Provided by Researchers

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

Additional Relevant MeSH Terms

  • Abdomen Hernia