Intracutaneous Versus Transcutaneous Sutures in the Face (IC vs TC Sutures)

January 20, 2017 updated by: Maastricht University Medical Center

Randomized Controlled Trial for the Cosmetic Result of Intracutaneous Versus Transcutaneous Sutures After Dermatologic Surgery in the Face

Rationale:

Skin cancer is common in Caucasians and often exists on sun-exposed areas, such as the face. Treatment of choice is mostly excision and result in an irreversible scar. As the incidence of skin cancer is rising, also among young people, it is important to obtain a good cosmetic outcome after treatment. It is believed that the type of closure of the wound after excision can influence the cosmetic result. Currently, primary closure of the excision can occur by transcutaneous (TC) or intracutaneous (IC) suturing. Both techniques are widely used among dermatologists and plastic surgeons and the choice is mainly dependent on the preference of the physician. Research comparing the cosmetic result of both techniques in the craniofacial area is lacking.

Objective:

Evaluation of the cosmetic result of transcutaneous sutures versus intracutaneous sutures in the craniofacial area.

Study design:

A randomized controlled single-blinded multi-center trial.

Study population:

Patients older than 18 years, with craniofacial skin tumor receiving surgery followed by primary closure at the department of Dermatology and Plastic Surgery of the Maastricht University Medical Centre, the department of Dermatology of Catharina hospital Eindhoven and the department of Plastic surgery of Orbis Medical Centre Sittard.

Intervention:

Excision of the tumor followed by IC sutures or TC sutures

Main study endpoints:

Cosmetic result measured on the Patient and Observer Scar Assessment Scale (POSAS) by the patient and the researcher 12 months after surgery.

Nature and extent of the burden and risks associated with participation, benefit and group relatedness:

All patients who participate have an indication for excision and will be assigned to one of the suture techniques. Both techniques are widely used in the regular patient care. Therefore, no extra risks are associated with it.

Patients will be asked to visit the hospital 3 months and 1 year following treatment, at which point a questionnaire will be filled in and the redness of the scar will be measured by means of non-invasive techniques. In addition, patients will be asked to apply a sunscreen on the scar daily during the first three months of follow-up.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

142

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Netherlands
    • Limburg
      • Maastricht, Limburg, Netherlands, 6229HX
        • Maastricht University Hospital
      • Sittard, Limburg, Netherlands
        • Orbis Medical Center
    • Noord-Brabant
      • Eindhoven, Noord-Brabant, Netherlands
        • Catharina hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • All patients aged 18 years or older with a skin tumour of minimal 5mm in diameter in the craniofacial area requiring an excision followed by primary closure will be included. If a patient has more than one lesion, the largest lesion that can be closed primarily will be included as a maximum of one tumour per patient will be studied.

Exclusion Criteria:

  • Patients with skin lesions on the ears, nose, mucosal part of the lips or eyelids as patients suited for excision but where a transplantation, flap or secondary granulation is necessary for reconstruction of the defect will be excluded. Patients not capable of informed consent will also be excluded.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: Transcutaneous sutures
Procedure: Transcutaneous sutures
Conventional excision followed by subcutaneous sutrues and transcutaneous sutures
Other: Intracutaneous sutures
Procedure: Intracutaneous sutures
Conventional excision followed by subcutaneous sutrues and intracutaneous sutures

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The study aims to evaluate the cosmetic outcome 12 months post-treatment of IC compared to TC sutures after excision of a skin tumor in the face. Cosmetic result after surgery in the face
Time Frame: after 1 year
The study aims to evaluate the cosmetic outcome 12 months post-treatment of IC compared to TC sutures after excision of a skin tumor in the face.
after 1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Maastricht University Medical Center

Investigators

  • Principal Investigator: Xiaomeng Liu, drs., Maastricht University Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2014

Primary Completion (Actual)

April 1, 2016

Study Completion (Actual)

April 1, 2016

Study Registration Dates

First Submitted

January 15, 2014

First Submitted That Met QC Criteria

April 24, 2014

First Posted (Estimate)

April 29, 2014

Study Record Updates

Last Update Posted (Estimate)

January 23, 2017

Last Update Submitted That Met QC Criteria

January 20, 2017

Last Verified

April 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NL46056.068.13

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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