Omnibond vs Dermabond

Center for Innovation and Research Organization

Status: Suspended

Conditions: Osteoarthritis

Treatments: Device: Omnibond Topical Skin Adhesive; Device: Dermabond Advanced Topical Skin Adhesive

Study type: Interventional

Funder types: NETWORK

Identifiers

NCT05173519

Omnibond001

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 310 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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 Subjects who have participated in this trial previously and who were withdrawn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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

---

310 participants in 2 patient groups

Omnibond topical skin adhesive

Active Comparator group

Treatment:

Device: Omnibond Topical Skin Adhesive

Dermabond topical skin adhesive

Active Comparator group

Treatment:

Device: Dermabond Advanced Topical Skin Adhesive