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OpenTrials
Completed

NCT Number: NCT01835405

LiquiBand Versus Dermabond Versus Sutures for Closure of Surgical Wounds

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.

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Key information

Conditions

Surgical Incisions Surgical Wound Wounds and Injuries

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Oncology Care Center, Beverly Hospital

Beverly, Massachusetts, 01915, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

LiquiBand Flex

Device

Dermabond Advanced

Device

Sutures (Prolene)

Device

Primary outcomes

  1. To compare cosmetic outcomes at follow up

    Time frame: 3 months post treatment

    Cosmesis to be evaluated by a panel of masked evaluators using a modified Hollander Wound Evaluation Scale

Sponsors and collaborators

Lead sponsor

Advanced Medical Solutions Ltd.

Industry

Registry information

Official study 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

Important dates

Study start
2013
Primary completion
2014
Study completion
2014
First posted
Apr 19, 2013
Registry last updated
Jan 24, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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