NCT01300520

Brief Summary

The current method of incision localization in many surgical procedures requires a doctor to reference a medical image, such as an X-ray, to judge where on the body an incision should be made. However, the precise information of the scan is not shown on the patient's skin. Surgeons commonly use palpation to locate the point of incision. They may feel for the area directly or find landmarks under the skin and estimate the location from there. The following factors further complicate palpation: overweight patients, foreign bodies that are difficult to feel for under the skin, fractures with little displacement, or locations under dense muscles. These difficulties are compounded for new surgeons, since palpation is a skill derived through experience. In many circumstances the surgeon only needs to know where to insert the tool or place the incision - they do not necessarily need to know the depth of the area of interest. If palpation proves ineffective, they may be forced to use fluoroscopy. By referencing the fluoroscopy image the surgeon moves a radiopaque marker, such as their surgical tool, closer to the area of interest. Fluoroscopy is time-consuming, and exposes medical personnel and the patient to radiation. Many fluoroscopic images may be required in a single procedure. By identifying the efficacy of this new medical device, "Target Tape", there is the potential outcome of making smaller incisions, faster localization, a reduction in fluoroscopy use and a reduced chance in surgical error and the associated costs. Target Tape is a non invasive device that is in a grid or ruler format that is placed against the subject's skin. The grid/ruler pattern will then appear on the medical imaging scan. Standard surgical skin ink is then used to place these markings in a defined pattern on the skin. This pattern mimics the Target Tape grid or ruler pattern. The medical practitioner can correlate these skin markings to the medical scan image to make their incisions in more accurate locations.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
5

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Mar 2011

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 18, 2011

Completed
3 days until next milestone

First Posted

Study publicly available on registry

February 21, 2011

Completed
8 days until next milestone

Study Start

First participant enrolled

March 1, 2011

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2011

Completed
2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2013

Completed
Last Updated

February 7, 2017

Status Verified

February 1, 2017

Enrollment Period

9 months

First QC Date

February 18, 2011

Last Update Submit

February 3, 2017

Conditions

Femoral FractureTibial Fracture

Keywords

FluoroscopyFemoral fractureTibial fractureSpinal Fusion

Outcome Measures

Primary Outcomes (1)

  • Incision Length

    Measuring the reduction in incision length from using Target Tape

    one year

Secondary Outcomes (2)

  • Reduction in Fluoroscopy Exposure

    one year

  • Procedure Time Savings

    One Year

Study Arms (2)

Target Tape

NO INTERVENTION

Including target tape in the procedure

Control

OTHER

Without target tape in the procedure

Device: Target Tape

Interventions

Target TapeDEVICE

Comparing procedures using Target Tape against procedures not using Target Tape

Control

Eligibility Criteria

Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Subject must be undergoing a radiological imaging, such as planar X-ray, fluoroscopy, CT or MRI

You may not qualify if:

  • Subjects who may have allergies to medical skin adhesives, medical skin inks or copper metal

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The University of British Columbia Department of Orthopaedics

Vancouver, British Columbia, V5Z1L8, Canada

Location

Related Publications (4)

  • Margarido CB, Mikhael R, Arzola C, Balki M, Carvalho JC. The intercristal line determined by palpation is not a reliable anatomical landmark for neuraxial anesthesia. Can J Anaesth. 2011 Mar;58(3):262-6. doi: 10.1007/s12630-010-9432-z. Epub 2010 Dec 3.

    PMID: 21128128BACKGROUND

  • Benzel, Edward. Spine Surgery: Techniques, Complication, Avoidance, and Management. 2nd. Philadelphia: Elsevier, 2005. 1521-1528. Print

    BACKGROUND

  • Gugala, Zbigniew, Arvind Nana, and Ronald Lindsey.

    BACKGROUND

  • Soar J, Peyton J, Leonard M, Pullyblank AM. Surgical safety checklists. BMJ. 2009 Jan 21;338:b220. doi: 10.1136/bmj.b220. No abstract available.

    PMID: 19158173BACKGROUND

MeSH Terms

Conditions

Femoral FracturesTibial Fractures

Condition Hierarchy (Ancestors)

Fractures, BoneWounds and InjuriesLeg Injuries

Study Officials

  • Piotr Blachut, MD, FRCS(C)

    The University of British Columbia Department of Orthopaedics

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 18, 2011

First Posted

February 21, 2011

Study Start

March 1, 2011

Primary Completion

December 1, 2011

Study Completion

December 1, 2013

Last Updated

February 7, 2017

Record last verified: 2017-02

Locations

CA(1)