LiquiBand Versus Dermabond Versus Sutures for Closure of Surgical Wounds

Advanced Medical Solutions

Status: Completed

Conditions: Surgical Incisions

Treatments: Device: Sutures (Prolene); Device: LiquiBand Flex; Device: Dermabond Advanced

Study type: Interventional

Funder types: Industry

Identifiers

NCT01835405

D-LBF001-05-1

Details and patient eligibility

About

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.

Enrollment: 66 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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66 participants in 3 patient groups

LiquiBand Flex

Active Comparator group

Description:

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.

Treatment:

Device: LiquiBand Flex

Dermabond Advanced

Active Comparator group

Description:

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.

Treatment:

Device: Dermabond Advanced

Sutures (Prolene)

Active Comparator group

Description:

Prolene™ Suture is indicated for use in general soft tissue approximation and/or ligation, including use in cardiovascular, ophthalmic and neurological procedures.

Treatment:

Device: Sutures (Prolene)