LiquiBand Versus Dermabond Versus Sutures for Closure of Surgical Wounds

Not Applicable

Completed

• Conditions: Surgical Incisions
• Interventions: Device: LiquiBand Flex; Device: Sutures (Prolene); Device: Dermabond Advanced

• Registration Number: NCT01835405
• Lead Sponsor: Advanced Medical Solutions Ltd.

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2013-02-20
• Study First Submitted: 2013-04-12
• Study First Submitted QC: 2013-04-18
• Study First Posted: 2013-04-19
• Primary Completion: 2014-02-14
• Study Completion: 2014-02-14
• Status Verified: 2017-01
• Last Update Submitted: 2017-01-23
• Last Update Posted: 2017-01-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 66

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
LiquiBand Flex	LiquiBand Flex	LiquiBand® Flex skin adhesive is indicated for topical application only, to hold closed easily approximated skin edges from surgical incisions, including punctures from minimally invasive surgery, and simple, thoroughly cleansed trauma-induced lacerations. It may be used in conjunction with, but not in place of deep dermal sutures.
Sutures (Prolene)	Sutures (Prolene)	Prolene™ Suture is indicated for use in general soft tissue approximation and/or ligation, including use in cardiovascular, ophthalmic and neurological procedures.
Dermabond Advanced	Dermabond Advanced	Dermabond Advanced™ adhesive is intended for topical application only, to hold closed easily approximated skin edges of wounds from surgical incisions, including incisions from minimally invasive surgery, and simple, thoroughly cleansed, trauma-induced lacerations. Dermabond Advanced ™ adhesive may be used in conjunction with, but not in place of, deep dermal stitches.

Primary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Oncology Care Center, Beverly Hospital; 🇺🇸 Beverly, Massachusetts, United States