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Trial record 2 of 8 for:    18090752 [PUBMED-IDS]

COEBICS: Comparison of Erythema Between Interrupted and Continuous Sutures (COEBICS)

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ClinicalTrials.gov Identifier: NCT02997306
Recruitment Status : Not yet recruiting
First Posted : December 20, 2016
Last Update Posted : December 20, 2016
Sponsor:
Information provided by (Responsible Party):
David Zloty, University of British Columbia

Brief Summary:
This is a randomized, controlled, prospective study which relies on computer-assisted skin image processing of scar photographs, to establish whether simple interrupted or running sutures are associated with the greatest degree of erythema when used to repair surgical defects arising from Moh's micrographic surgery (MMS) of facial skin cancers. Furthermore, through the use of the customized software that the investigators have developed for this purpose, an effort will be made to better understand the evolution (including progression and subsequent regression) of erythema over time in these scars.

Condition or disease Intervention/treatment Phase
Surgical Scar Erythema Procedure: Superior/Medial Running Sutures Procedure: Inferior/Lateral Running Sutures Not Applicable

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: COEBICS: Comparison of Erythema Between Interrupted and Continuous Sutures
Study Start Date : January 2017
Estimated Primary Completion Date : October 2017
Estimated Study Completion Date : December 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Scars

Arm Intervention/treatment
Experimental: Superior/Medial Running Sutures
In this cohort, the running sutures will be randomized to be oriented on Superior/Medial half of the scar, and the remaining half of the scar will be closed with simple interrupted sutures.
Procedure: Superior/Medial Running Sutures
Simple interrupted stitches and running (continuous) stitches are the two most frequently used suturing techniques. The erythema secondary to these suturing techniques will be compared by utilizing them side-by-side for closure of post-Moh's surgical defect repair in each patient. This intervention consists of running sutures being used for closure of the Superior/Medial half of the incision, and interrupted sutures being used on the Inferior/Lateral half of the incision.

Experimental: Inferior/Lateral Running Sutures
In this cohort, the running sutures will be randomized to be oriented on Inferior/Lateral half of the scar, and the remaining half of the scar will be closed with simple interrupted sutures.
Procedure: Inferior/Lateral Running Sutures
Simple interrupted stitches and running (continuous) stitches are the two most frequently used suturing techniques. The erythema secondary to these suturing techniques will be compared by utilizing them side-by-side for closure of post-Moh's surgical defect repair in each patient. This intervention consists of running sutures being used for closure of the Inferior/Lateral half of the incision, and interrupted sutures being used on the Superior/Medial half of the incision.




Primary Outcome Measures :
  1. Change in the Intensity of Scar Erythema [ Time Frame: 1 week, 8 weeks, and 6 months post-operatively ]
    The degree of scar erythema post-operatively will be assessed in each half of each patient's scar by quantifying both the intensity and the surface area of erythema. This will be achieved digitally by employing the customized software developed by the investigators for this purpose.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

Subjects will be included only if the following conditions are all met:

  1. The subject is 18 years of age or older.
  2. The subject is presenting with a facial surgical defect after MMS that requires a repair resulting in a scar of more than 4 cm in length.
  3. The subject is willing and capable of cooperating to the extent and degree required by the protocol.

Exclusion Criteria:

Subjects will be excluded if any of the following conditions are met:

  1. The subject has a history of keloidal scarring.
  2. The subject will require radiation therapy after surgery.
  3. The subject is participating in another investigational drug or device study within 30 days of proposed study enrolment.
  4. The subject is not able to fully understand the protocol and consent documents.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02997306


Contacts
Contact: David Zloty, MD, FRCPC 604-875-4888 David.Zloty@vch.ca
Contact: Ali Majdzadeh 778-887-4040 amajdzadeh@alumni.ubc.ca

Locations
Canada, British Columbia
Dermatologic Surgery Centre at the Vancouver General Hospital Skin Care Centre Not yet recruiting
Vancouver, British Columbia, Canada, V5Z 4E8
Contact: David Zloty, MD, FRCPC    604-875-4888    David.Zloty@vch.ca   
Principal Investigator: David Zloty, MD, FRCPC         
Sub-Investigator: Ali Majdzadeh         
Sub-Investigator: Ardalan Akbari, BSc         
Sponsors and Collaborators
University of British Columbia
Investigators
Principal Investigator: David Zloty, MD, FRCPC Department of Dermatology and Skin Science, University of British Columbia

Publications:
Responsible Party: David Zloty, Clinical Professor, University of British Columbia
ClinicalTrials.gov Identifier: NCT02997306     History of Changes
Other Study ID Numbers: H16-01802
First Posted: December 20, 2016    Key Record Dates
Last Update Posted: December 20, 2016
Last Verified: December 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by David Zloty, University of British Columbia:
Moh's Surgery
Erythema
Face
Simple Interrupted Sutures
Running Sutures
Image Processing

Additional relevant MeSH terms:
Erythema
Skin Diseases