LiquiBand Versus Dermabond Versus Sutures for Closure of Surgical Wounds

NCT01835405 | Completed

• 1 other identifier: D-LBF001-05-1
• Study Type: interventional
• Target: 66
• Locations: 1 country
• Sites: 1

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.

Conditions

Surgical Incisions

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (3)

LiquiBand Flex

ACTIVE COMPARATOR

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.

Device: LiquiBand Flex

Dermabond Advanced

ACTIVE COMPARATOR

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.

Device: Dermabond Advanced

Sutures (Prolene)

ACTIVE COMPARATOR

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

Device: Sutures (Prolene)

Interventions

LiquiBand Flex DEVICE

LiquiBand Flex

Dermabond Advanced DEVICE

Dermabond Advanced

Sutures (Prolene) DEVICE

Sutures (Prolene)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Advanced Medical Solutions Ltd.: lead

Study Sites (1)

Oncology Care Center, Beverly Hospital

Beverly, Massachusetts, 01915, United States

Location

MeSH Terms

Conditions

Surgical Wound

Interventions

Sutures

Condition Hierarchy (Ancestors)

Wounds and Injuries

Intervention Hierarchy (Ancestors)

Surgical Fixation Devices; Surgical Equipment; Equipment and Supplies

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 12, 2013
• First Posted: April 19, 2013
• Study Start: February 20, 2013
• Primary Completion: February 14, 2014
• Study Completion: February 14, 2014
• Last Updated: January 24, 2017

Record last verified: 2017-01

Locations

US (1)