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

NCT02125058 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 142

Last updated 2017-01-23

No results posted yet for this study

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.

Conditions

  • Skin Tumour
  • Surgery

Interventions

PROCEDURE

Transcutaneous sutures

Conventional excision followed by subcutaneous sutrues and transcutaneous sutures

PROCEDURE

Intracutaneous sutures

Conventional excision followed by subcutaneous sutrues and intracutaneous sutures

Sponsors & Collaborators

  • Maastricht University Medical Center

    lead OTHER

Principal Investigators

  • Xiaomeng Liu, drs. · Maastricht University Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-04-30
Primary Completion
2016-04-30
Completion
2016-04-30

Countries

  • Netherlands

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02125058 on ClinicalTrials.gov