Dermabond PRINEO for Total Shoulder Arthroplasty

NCT03860181 | Completed Results FDA Device

• 1 other identifier: 00084714
• Study Type: interventional
• Target: 89
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (3)

• Comparison of the Total Cost of Wound Closure When Using Dermabond PRINEO Versus the Surgeon's Control.

  Closure cost was calculated by evaluating the cost of wound closure products ($) per patient, plus the cost of the operating room ($) per minute, multiplied by the closure time (minutes) per centimeter of incision length, then multiplied by the average incision length (cm) per patient.

  3 months post-operative

• Comparing Patient Satisfaction Ratings Between D.PRINEO and Controls

  Patient satisfaction ratings were on a scale from 0-10, where 0 = very dissatisfied and 10 = very satisfied.

  3 months post-operatively

• Mean Closure Time Per Centimeter of Incision

  This closure time was measured from the first stitch for closure to the application of the wound dressing. The incision length was measured immediately after closure.

  Immediate/at time of surgery

Secondary Outcomes (8)

• Median Overall Opinion Score Reported by Operating Surgeon

  Up to 3 months

• Median Wound Inflammation Score (AIRE) Reported by Operating Physician

  Up to 3 months post surgery

• Median Scar Assessment (POSAS) by Operating Surgeon

  Up to 3 months post surgery

• Wound Cosmesis (MHCS) Score by Operating Physician

  Up to 3 months post surgery

• Differences Between Patient and Surgeon Total POSAS Scores

  3 months post-operatively

Study Arms (4)

Traditional Dermabond + subcuticular sutures - Surgeon 1

ACTIVE COMPARATOR

Subcuticular sutures with traditional Dermabond applied to incision.

Procedure: Subcuticular Sutures - Surgeon 1

Metal staples - Surgeon 2

ACTIVE COMPARATOR

Metal staples

Procedure: Metal Staples - Surgeon 2

Dermabond PRINEO - Surgeon 1

EXPERIMENTAL

Dermabond PRINEO System

Device: PRINEO - Surgeon 1

Dermabond PRINEO - Surgeon 2

EXPERIMENTAL

Dermabond PRINEO System

Device: PRINEO - Surgeon 2

Interventions

Subcuticular Sutures - Surgeon 1 PROCEDURE

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

Traditional Dermabond + subcuticular sutures - Surgeon 1

Metal Staples - Surgeon 2 PROCEDURE

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

Metal staples - Surgeon 2

PRINEO - Surgeon 1 DEVICE

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.

Dermabond PRINEO - Surgeon 1

PRINEO - Surgeon 2 DEVICE

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.

Dermabond PRINEO - Surgeon 2

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

Subjects will be included if: * They are 18 years or older; * They are undergoing primary total shoulder arthroplasty by the principal and co-investigator. * They are willing and have the capacity to provide informed consent; * They expect to continue their post-operative follow up care with their operating surgeons at Medical University of South Carolina (MUSC). Subjects will be excluded if: * They have a unique, identifying tattoo or skin marking within 2 inches of intended site of surgical incision * They self-report a known hypersensitivity to cyanoacrylate, formaldehyde, benzalkonium chloride, or pressure sensitive adhesive; * They self-report or have a documented prior ipsilateral shoulder arthroplasty or other open ipsilateral shoulder surgery utilizing the delto-pectoral approach; * Their medical record shows that they are HIV positive or otherwise immunocompromised; * Their medical record shows a skin abnormality or dermatological condition which affects skin healing; * They report a personal or family history of significant keloid or significant hypertrophic scar formations, or other problems with wound healing.

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Medical University of South Carolina: lead
• Johnson & Johnson: collaborator

Study Sites (1)

Medical University of South Carolina

Charleston, South Carolina, 29425, United States

Location

MeSH Terms

Conditions

Surgical Wound

Condition Hierarchy (Ancestors)

Wounds and Injuries

Results Point of Contact

• Title: Josef Eichinger, MD
• Organization: Medical University of South Carolina

eichinge@musc.edu

843-876-0111

Study Officials

• Josef Eichinger, MD

  Medical University of South Carolina

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: February 27, 2019
• First Posted: March 1, 2019
• Study Start: March 25, 2019
• Primary Completion: June 23, 2020
• Study Completion: June 23, 2020
• Last Updated: October 1, 2021
• Results First Posted: August 25, 2021

Record last verified: 2021-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)