The Effects of Post-Operative Interventions on Surgical Site Occurrences in Abdominal Wall Reconstructions: A Randomized Controlled Trial
Status: Recruiting
Location: See location...
Intervention Type: Drug, Device
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY
Randomized controlled trial to compare SSO's in abdominal wall reconstruction patients using Prevena, Prineo, and traditional incisional dressings.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: t
View:
• 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
Locations
United States
Ohio
Department of Plastic Surgery
RECRUITING
Columbus
Contact Information
Primary
Jeffrey Janis, MD
Jeffrey.Janis@osumc.edu
6143661242
Backup
Benjamin Sarac, MD
Benjamin.Sarac@osumc.edu
6143661242
Time Frame
Start Date: 2021-09-17
Estimated Completion Date: 2028-05-01
Participants
Target number of participants: 300
Treatments
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.
Related Therapeutic Areas
Sponsors
Leads: Ohio State University