Omnibond vs Dermabond

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms	No
Study Type An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes. An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes. Searching Both is inclusive of interventional and observational studies.	Interventional
Eligible Ages	18 Years and Over
Gender	All

More Inclusion & Exclusion Criteria

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 Subjects who have participated in this trial previously and who were withdrawn. 5.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 Details

Trial ID: This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.	NCT05173519
Phase Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans. Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data. Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs. Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.	N/A
Lead Sponsor The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.	Center for Innovation and Research Organization
Principal Investigator The person who is responsible for the scientific and technical direction of the entire clinical study.	Tiffany Morrison, MS
Principal Investigator Affiliation	Center for Innovation and Research Organization
Agency Class Category of organization(s) involved as sponsor (and collaborator) supporting the trial.	Other
Overall Status	Enrolling by invitation
Countries	United States
Conditions The disease, disorder, syndrome, illness, or injury that is being studied.	Osteoarthritis

Additional Details

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.

Arms & Interventions

Arms

Active Comparator: Omnibond topical skin adhesive

Active Comparator: Dermabond topical skin adhesive

Interventions

Device: - Omnibond Topical Skin Adhesive

Application of Omnibond topical skin adhesive to close incision following surgery

Device: - Dermabond Advanced Topical Skin Adhesive

Application of Dermabond topical skin adhesive to close incision following surgery

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

Columbia University, New York, New York

Status

Address

Columbia University

New York, New York, 10032

JIS Orthopaedics, New Albany, Ohio

Status

Address

JIS Orthopaedics

New Albany, Ohio, 43054

Rothman Orthopaedic Institute, Philadelphia, Pennsylvania

Status

Address

Rothman Orthopaedic Institute

Philadelphia, Pennsylvania, 19107

Rhode Island Hospital, Providence, Rhode Island

Status

Address

Rhode Island Hospital

Providence, Rhode Island, 02903

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