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

NCT ID: NCT02125058

Last Updated: 2017-01-23

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 142 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-04-30
• Study Completion Date: 2016-04-30

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.

Conditions

Skin Tumour; Surgery

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Transcutaneous sutures

Transcutaneous sutures

Group Type: OTHER

Transcutaneous sutures

Intervention Type: PROCEDURE

Conventional excision followed by subcutaneous sutrues and transcutaneous sutures

Intracutaneous sutures

Intracutaneous sutures

Group Type: OTHER

Intracutaneous sutures

Intervention Type: PROCEDURE

Conventional excision followed by subcutaneous sutrues and intracutaneous sutures

Interventions

Transcutaneous sutures

Conventional excision followed by subcutaneous sutrues and transcutaneous sutures

Intervention Type: PROCEDURE

Intracutaneous sutures

Conventional excision followed by subcutaneous sutrues and intracutaneous sutures

Intervention Type: PROCEDURE

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Maastricht University Medical Center

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Xiaomeng Liu, drs.

Role: PRINCIPAL_INVESTIGATOR

Maastricht University Hospital

Locations

Maastricht University Hospital

Maastricht, Limburg, Netherlands

Orbis Medical Center

Sittard, Limburg, Netherlands

Catharina Hospital

Eindhoven, North Brabant, Netherlands

Countries

Netherlands

Other Identifiers

NL46056.068.13

Identifier Type: -

Identifier Source: org_study_id