Status:
COMPLETED
LiquiBand Versus Dermabond Versus Sutures for Closure of Surgical Wounds
Lead Sponsor:
Advanced Medical Solutions Ltd.
Conditions:
Surgical Incisions
Eligibility:
All Genders
18+ years
Phase:
NA
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 sur...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
February 20 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 14 2014
Estimated Enrollment :
66 Patients enrolled
Trial Details
Trial ID
NCT01835405
Start Date
February 20 2013
End Date
February 14 2014
Last Update
January 24 2017
Active Locations (1)
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1
Oncology Care Center, Beverly Hospital
Beverly, Massachusetts, United States, 01915