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

Conditions

• Abdomen Hernia

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Accepted

Interventions

• Prevena — DEVICE
  Incisions will be dressed with closed incisional negative pressure wound therapy
• Prineo — DEVICE
  Incisions will be dressed with Prineo
• Traditional — DRUG
  Incisions will be dressed with bacitracin/xeroform

Study Details

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

Key Dates

Start date

Sep 17, 2021

Status verified

Mar 2025

Primary completion

May 1, 2028

Completion

May 1, 2028

Study Design

Enrollment

300 participants (estimated)

Allocation

RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

PREVENTION

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.

Primary Outcome Measure

Rate of Infection [ Time Frame: At 6 weeks postoperatively ]

Central Contacts

• Jeffrey Janis, MD
  6143661242
  [email protected]
• Benjamin Sarac, MD
  6143661242
  [email protected]

Locations (1)

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