NCT05173519

Brief Summary

This prospective, randomized, controlled, blinded clinical trial is designed to assess the incidence of all time and all types of wound-related complications following total joint arthroplasty (TJA) when two different types of topical skin adhesives are used to close the incision.

Trial Health

33
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Trial recruitment is currently suspended
Enrollment
310

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Oct 2022

Typical duration for not_applicable

Geographic Reach
1 country

4 active sites

Status
suspended

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 29, 2021

Completed
1 month until next milestone

First Posted

Study publicly available on registry

December 30, 2021

Completed
10 months until next milestone

Study Start

First participant enrolled

October 25, 2022

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2025

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2025

Completed
Last Updated

February 7, 2024

Status Verified

February 1, 2024

Enrollment Period

2.2 years

First QC Date

November 29, 2021

Last Update Submit

February 5, 2024

Conditions

Osteoarthritis

Outcome Measures

Primary Outcomes (1)

  • All time wound complications

    any occurrence of a wound-related complication following surgery

    From surgery to 30 days post-op

Secondary Outcomes (3)

  • Dry time

    From time of initial product placement on the skin to when the entire application is dry to the touch with a gloved hand

  • User satisfaction with study treatment

    Up to 1 hour after study product application

  • Subject satisfaction with study treatment

    Up to 14 days following surgery

Study Arms (2)

Omnibond topical skin adhesive

ACTIVE COMPARATOR
Device: Omnibond Topical Skin Adhesive

Dermabond topical skin adhesive

ACTIVE COMPARATOR
Device: Dermabond Advanced Topical Skin Adhesive

Interventions

Omnibond Topical Skin AdhesiveDEVICE

Application of Omnibond topical skin adhesive to close incision following surgery

Omnibond topical skin adhesive
Dermabond Advanced Topical Skin AdhesiveDEVICE

Application of Dermabond topical skin adhesive to close incision following surgery

Dermabond topical skin adhesive

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patient ≥18 years old
  • Male or non-pregnant, non-lactating, postmenopausal or surgically sterilized females
  • Subjects scheduled to undergo primary, elective total knee arthroplasty or total hip arthroplasty
  • Subjects provide informed consent, which will consist of reading, signing, and dating the informed consent document after the Investigator, sub-Investigator or other designated study staff member has explained the study procedures, risks, and contact information
  • Subjects deemed able to understand and comply with study visit schedule and procedures

You may not qualify if:

  • Local skin conditions such as dermatitis, eczema, psoriasis that, in the opinion of the investigator, will make it difficult to assess wound complications or local skin reactions following surgery
  • Pregnant, lactating females, or females of childbearing potential not willing to practice an effective method of contraception
  • Active or previous infection in the skin or the knee or hip to be operated, evidence of gangrene
  • Subjects who have participated in this trial previously and who were withdrawn
  • Subjects with known allergies to product components including cyanoacrylate, formaldehyde, benzalkonium chloride or have known allergies or skin sensitivity to the Convatec Aquacel dressing.
  • Inability or refusal to provide informed consent or follow study and wound care instructions

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

Columbia University

New York, New York, 10032, United States

Location

JIS Orthopaedics

New Albany, Ohio, 43054, United States

Location

Rothman Orthopaedic Institute

Philadelphia, Pennsylvania, 19107, United States

Location

Rhode Island Hospital

Providence, Rhode Island, 02903, United States

Location

MeSH Terms

Conditions

Osteoarthritis

Condition Hierarchy (Ancestors)

ArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic Diseases

Study Officials

  • Tiffany Morrison, MS

    Center for Innovation and Research Organization

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
NETWORK
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 29, 2021

First Posted

December 30, 2021

Study Start

October 25, 2022

Primary Completion

January 1, 2025

Study Completion

February 1, 2025

Last Updated

February 7, 2024

Record last verified: 2024-02

Locations

US(4)