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

Primary Purpose

Skin Tumour, Surgery

Status
Completed
Phase
Not Applicable
Locations
Netherlands
Study Type
Interventional
Intervention
Transcutaneous sutures
Intracutaneous sutures
Sponsored by
Maastricht University Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Skin Tumour focused on measuring intracutaneous sutures, transcutaneous sutures, dermatological surgery, facial area

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Maastricht University Hospital
  • Orbis Medical Center
  • Catharina Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Other

Other

Arm Label

Transcutaneous sutures

Intracutaneous sutures

Arm Description

Transcutaneous sutures

Intracutaneous sutures

Outcomes

Primary Outcome Measures

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
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.

Secondary Outcome Measures

Full Information

First Posted
January 15, 2014
Last Updated
January 20, 2017
Sponsor
Maastricht University Medical Center
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1. Study Identification

Unique Protocol Identification Number
NCT02125058
Brief Title
Intracutaneous Versus Transcutaneous Sutures in the Face (IC vs TC Sutures)
Official Title
Randomized Controlled Trial for the Cosmetic Result of Intracutaneous Versus Transcutaneous Sutures After Dermatologic Surgery in the Face
Study Type
Interventional

2. Study Status

Record Verification Date
April 2015
Overall Recruitment Status
Completed
Study Start Date
April 2014 (undefined)
Primary Completion Date
April 2016 (Actual)
Study Completion Date
April 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Maastricht University Medical Center

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Skin Tumour, Surgery
Keywords
intracutaneous sutures, transcutaneous sutures, dermatological surgery, facial area

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
142 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Transcutaneous sutures
Arm Type
Other
Arm Description
Transcutaneous sutures
Arm Title
Intracutaneous sutures
Arm Type
Other
Arm Description
Intracutaneous sutures
Intervention Type
Procedure
Intervention Name(s)
Transcutaneous sutures
Intervention Description
Conventional excision followed by subcutaneous sutrues and transcutaneous sutures
Intervention Type
Procedure
Intervention Name(s)
Intracutaneous sutures
Intervention Description
Conventional excision followed by subcutaneous sutrues and intracutaneous sutures
Primary Outcome Measure Information:
Title
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
Description
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.
Time Frame
after 1 year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Xiaomeng Liu, drs.
Organizational Affiliation
Maastricht University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Maastricht University Hospital
City
Maastricht
State/Province
Limburg
ZIP/Postal Code
6229HX
Country
Netherlands
Facility Name
Orbis Medical Center
City
Sittard
State/Province
Limburg
Country
Netherlands
Facility Name
Catharina Hospital
City
Eindhoven
State/Province
Noord-Brabant
Country
Netherlands

12. IPD Sharing Statement

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

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