Health Condition 1: null- Patients undergoing a planned elective CABG procedure (likely to have incision for saphenous vein harvesting) and have easily approximated skin edges of wounds from incisions.
Conditions
Interventions
Intervention1: MAR-CUTIS®: Use of MAR-CUTIS® to close easily approximated skin edges of wounds from surgical incisions
Control Intervention1: NONE: N/A
Sponsors
Medical Adhesive Revolution GmbH
Eligibility
Inclusion criteria
Inclusion criteria: 1. Subject age of > 18 years and Male only 2. Subject undergoing a planned elective Coronary artery bypass grafting (CABG) surgical procedure and likely to have an incision for saphenous vein harvesting. 3. Subject with not more than two co-morbidities and in relatively good general health in the opinion of the Investigator with no conditions that would significantly impact wound healing as determined by medical history and review of recent concomitant medications. 4. Be willing to follow instructions for incision care as instructed by the investigator, and refrain from swimming or soaking in a tub during the first 10 days of the study. 5. Subject or their legal representative is willing and able to sign an Ethics Committee approved informed consent form and agrees to comply with study requirements.
Exclusion criteria
Exclusion criteria: 1. Have peripheral vascular disease; 2. Have insulin dependent diabetes mellitus; 3. Be known to have a blood clotting disorder; 4. Be receiving antibiotic therapy for pre-existing condition or infection; 5. Be known to be HbsAg positive, HIV positive, HCV positive or otherwise immunocompromised; 6. Have known personal or family history of keloid formation or hypertrophy; 7. Be currently taking systemic steroids; 8. Have known or suspected allergy or sensitivity to urethane, cyanoacrylate, formaldehyde, tapes or adhesives; 9. Have incision type or location known to have an incidence of cyanosis or other healing abnormalities; 10. Have burst or stellate lacerations due to crush or hard blow, 11. Have animal or human bites 12. Have decubitus ulcer. 13. Be participating in any current clinical trial or have participated in any clinical trial within 30 days of enrolment in this study; 14. Lab values showing inflammation parameters above normal (e.g. Luc > 20,000)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. The primary safety endpoint is the incidence of all device related adverse events. 2. The primary effectiveness endpoint is to show a sustained and safe wound closure with MAR-CUTIS®. Wounds will be evaluated for apposition (50, 50â??99, and 100%), and dehiscence (50% and 50%).Timepoint: 10 Days | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Cosmetic outcome of using MAR-CUTIS® Topical Skin Adhesive as topical skin wound closure. Wounds will be evaluated for cosmetics using a modified Hollander Wound Evaluation Scale (HWES).Timepoint: 10 Days | — |
Countries
India
Contacts
Public ContactNaresh Kumar Pagidimarry
STAR Hospitals
Outcome results
None listed