Surgical Incisions
Conditions
Brief summary
To evaluate the cosmetic outcome, effectiveness, user and subject satisfaction, and safety of LiquiBand® Flex in relation to DermaBond Advanced™ and conventional sutures for the topical closure of surgical wounds.
Interventions
Sponsors
Advanced Medical Solutions Ltd.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Male or Female aged 18 or older on day of enrollment * Scheduled for surgical procedure by a delegated study surgeon * Fresh surgical wound with evenly distributed tension over length of incision * Willing and able to sign informed consent * Agree to return for 2 week (+/- 7 days) and 3 month (90 days +/- 7 days) post-procedure follow-up visit
Exclusion criteria
* Known sensitivity to cyanoacrylates, formaldehyde or acetone products * Wounds in which incision edges are under high tension or not easily apposed (after deep layer suture), or over joints (unless immobilized) * Wounds less than 15mm in length * Wounds in which haemostasis is not able to be achieved, eg, drain is placed or Warfarin level \>2.5 prior to surgery * Wounds in which deep closure could not be achieved * Surgical procedures involving mucus membranes or eyes * Mental incapacity, dementia, or inability to give informed consent * Pregnant or nursing * Disease related or pharmacologically immuno-compromised
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| To compare cosmetic outcomes at follow up | 3 months post treatment | Cosmesis to be evaluated by a panel of masked evaluators using a modified Hollander Wound Evaluation Scale |
Countries
United States
Outcome results
None listed