LiquiBand Versus Dermabond Versus Sutures for Closure of Surgical Wounds

Surgical Incisions Clinical Trial

Official title:

A Prospective, Single-centre Study to Compare the Use of LiquiBand® Flex, Dermabond Advanced™ or Conventional Sutures for the Topical Closure of Surgical Wounds

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01835405
• Other study ID #: D-LBF001-05-1
• Status: Completed
• Phase: N/A
• First received: April 12, 2013
• Last updated: January 23, 2017
• Start date: February 20, 2013
• Est. completion date: February 14, 2014

Study information

• Verified date: January 2017
• Source: Advanced Medical Solutions (Plymouth) Ltd
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 66
• Est. completion date: February 14, 2014
• Est. primary completion date: February 14, 2014
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Surgical Incisions

Intervention

Device:
• LiquiBand Flex

• Dermabond Advanced

• Sutures (Prolene)

Locations

Country	Name	City	State
United States	Oncology Care Center, Beverly Hospital	Beverly	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
Advanced Medical Solutions (Plymouth) Ltd

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To compare cosmetic outcomes at follow up	Cosmesis to be evaluated by a panel of masked evaluators using a modified Hollander Wound Evaluation Scale	3 months post treatment