MedTrace Logo

Dermabond PRINEO for Total Shoulder Arthroplasty

NCT03860181 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 89

Last updated 2021-10-01

Study results available
· View outcomes & findings →

Summary

This is a research study to find out whether wound closure (the process of closing the surgical wound after the procedure is complete) with Dermabond PRINEO Skin Closure System (PRINEO) will be faster and improve wound healing compared to standard closing methods after total shoulder replacement. The PRINEO system involves using running stitches to close the wound, and then taping over the sutures with a sticky film that holds the wound closed.

Conditions

  • Surgical Wound
  • Shoulder Arthritis
  • Surgical Incision

Interventions

PROCEDURE

Subcuticular Sutures - Surgeon 1

This intervention closes incisions after shoulder arthroplasty using subcuticular sutures with Dermabond.The deep layer closure will require interrupted sutures.

PROCEDURE

Metal Staples - Surgeon 2

This intervention closes incisions after shoulder arthroplasty with metal staples. The deep layer closure will require interrupted sutures,

DEVICE

PRINEO - Surgeon 1

The closure system uses the Dermabond PRINEO (which is similar to clear tape stuck over the wound) placed over running sutures for both the deep and subcuticular layer.

DEVICE

PRINEO - Surgeon 2

The closure system uses the Dermabond PRINEO (which is similar to clear tape stuck over the wound) placed over running sutures for both the deep and subcuticular layer.

Sponsors & Collaborators

  • Johnson & Johnson

    collaborator INDUSTRY

  • Medical University of South Carolina

    lead OTHER

Principal Investigators

  • Josef Eichinger, MD · Medical University of South Carolina

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-03-25
Primary Completion
2020-06-23
Completion
2020-06-23
FDA Device
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03860181 on ClinicalTrials.gov