NCT02125058

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

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 142 (actual)
• Sponsor: Maastricht University Medical Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Type	Name	Description
PROCEDURE	Transcutaneous sutures	Conventional excision followed by subcutaneous sutrues and transcutaneous sutures
PROCEDURE	Intracutaneous sutures	Conventional excision followed by subcutaneous sutrues and intracutaneous sutures

Timeline

• Start date: 2014-04-01
• Primary completion: 2016-04-01
• Completion: 2016-04-01
• First posted: 2014-04-29
• Last updated: 2017-01-23

Locations

3 sites across 1 country: Netherlands