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Completed

NCT Number: NCT02149979

Closure of Skin Incision Using CO2 Laser

The purpose of this study is to evaluate the safety and effectiveness of using Temperature Controlled Laser Soldering System for soft tissue bonding.

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Key information

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Department of Surgery B, "HaEmek" Medical Center, Afula, Israel

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About this study

Skin incisions can be closed by a variety of method which create temporary approximation of the wound edges until natural healing process ensue and reach a phase, where it is closed and can sustain the daily tensile forces.

The wound closure devices include sutures, staples, tapes, tissue adhesives. The Applied Physics group at the Tel Aviv University has developed a Temperature Controlled CO2 Laser Soldering system for soft tissue bonding.

This system includes features that make laser soldering suitable for clinical use. The Temperature Controlled Laser Soldering System is composed of CO2 fiberoptic laser device, Infrared fiber-optic radiometer, a computerized temperature control program, propriety grip device (Clamps) and concentrated Human Albumin as a soldering agent.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Male/Female age 18-65.
  • Subject is scheduled for laparoscopic cholecystectomy surgery.
  • Subject able to comprehend and sign informed consent for participation in this study.
  • Ability to comply with the study procedures and follow-up visits

Exclusion criteria

  • Subject has a history of hypertrophic or keloid scar formation
  • Subject is a pregnant and/or nursing woman
  • Subject has a known allergy to blood products
  • Subject is suffering from a bleeding disorders or using anticoagulant medications
  • Subject is suffering from hepatic or renal disorder
  • Subject is suffering from rheumatic and / or collagen disorder
  • Subject is using steroids
  • Subject is suffering from immunosuppressive disorder
  • Subject is suffering from Ischemic Heart Disease (IHD)
  • Subject is suffering from neoplastic disorder
  • Subject who has had an active illness within 4 weeks of study enrollment
  • Subject is participating in another study for an investigational drug and/or device within 3 months of study enrollment
  • Any condition which would make the participant, in the opinion of the investigator, unsuitable for the study.

Treatment and study plan

Temperature Controlled Laser Soldering

Device

This study had a prospective within-subject design. Patients allocated to laparoscopic cholecystectomy procedure were enrolled. After the completion of the laparoscopic cholecystectomy surgical procedure, 4 trocar port sites were randomly either sutured or laser soldered by employing the temperature-controlled laser soldering system.

Primary outcomes

  1. Primary study endpoint will be to establish the safety of using the Temperature Controlled Laser Soldering System for skin bonding and wounds closure. Safety will be established by paucity of serious adverse events and adverse events.

    Time frame: 3 months

Secondary outcomes

  1. Re-intervention: A subject is scored a success (1) if he had No Re-intervention by 3 months; otherwise he is scored a failure (0).

    Time frame: 3 months

  2. Wound dehiscence of at least 50% of wound length

    Time frame: 3 months

Sponsors and collaborators

Lead sponsor

Avraham Katzir

Other

Registry information

Important dates

Study start
2007
Primary completion
2008
Study completion
2009
First posted
May 29, 2014
Registry last updated
May 29, 2014

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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