Omnibond vs Dermabond

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

SUSPENDED

Clinical Phase

NA

Total Enrollment

310 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-10-25

Study Completion Date

2025-02-28

Brief Summary

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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.

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Detailed Description

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The aim of this study is to assess the incidence of incision healing complications in patients undergoing primary total knee replacement and total hip replacement treated with either Omnibond or Dermabond advanced topical skin adhesive. All patients undergoing a primary, elective TKA and THA at participating centers that sign a consent form will be followed up for a period of up to 30 days to determine if there are any incision healing complications.

Secondary outcomes will include dry time of the topical skin adhesive, user satisfaction, patient satisfaction, and incidence of adverse events.

Conditions

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Osteoarthritis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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Omnibond topical skin adhesive

Group Type ACTIVE_COMPARATOR

Omnibond Topical Skin Adhesive

Intervention Type DEVICE

Application of Omnibond topical skin adhesive to close incision following surgery

Dermabond topical skin adhesive

Group Type ACTIVE_COMPARATOR

Dermabond Advanced Topical Skin Adhesive

Intervention Type DEVICE

Application of Dermabond topical skin adhesive to close incision following surgery

Interventions

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Omnibond Topical Skin Adhesive

Application of Omnibond topical skin adhesive to close incision following surgery

Intervention Type DEVICE

Dermabond Advanced Topical Skin Adhesive

Application of Dermabond topical skin adhesive to close incision following surgery

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

1. Patient ≥18 years old
2. Male or non-pregnant, non-lactating, postmenopausal or surgically sterilized females
3. Subjects scheduled to undergo primary, elective total knee arthroplasty or total hip arthroplasty
4. 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
5. Subjects deemed able to understand and comply with study visit schedule and procedures

Exclusion Criteria

1. 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
2. Pregnant, lactating females, or females of childbearing potential not willing to practice an effective method of contraception
3. Active or previous infection in the skin or the knee or hip to be operated, evidence of gangrene
4. Subjects who have participated in this trial previously and who were withdrawn
5. Subjects with known allergies to product components including cyanoacrylate, formaldehyde, benzalkonium chloride or have known allergies or skin sensitivity to the Convatec Aquacel dressing.
6. Inability or refusal to provide informed consent or follow study and wound care instructions

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No