Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 3:32 AM
Ignite Modification Date:
2025-12-25 @ 3:32 AM
NCT ID:
NCT01835405
Eligibility Criteria:
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
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT01835405
Study Brief:
Protocol Section:
NCT01835405