Evaluation of the cosmetic result after 12 months of transcutaneous sutures versus intracutaneous sutures in the craniofacial area.
ID
Source
Brief title
Condition
- Skin neoplasms malignant and unspecified
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Cosmetic result measured on the POSAS (Patient and Observer Scar Assessment
Scale) by the patient and the researcher 12 months after surgery.
Secondary outcome
We will determine complications within two weeks and cosmetic result on the
four-point scale (bad, average, good, excellent) after 3 and 12 months between
both treatment.
Background summary
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. These techniques are the
most often used ones 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.
Study objective
Evaluation of the cosmetic result after 12 months of transcutaneous sutures
versus intracutaneous sutures in the craniofacial area.
Study design
A randomized controlled single-blinded multi-center trial.
Intervention
Local excision followd by intracutaneous or transcutaneous sutures. In both
groups sutures will be removed after zeven days and patients are asked to apply
a sunscreen on the scar daily for the first three months.
Study burden and risks
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. The hospital
visits will, if possible, be combined with regular follow-up visits.
In addition, they are asked to apply a sunscreen on the scar once daily during
the follow-up of the first three months.
P. Debyelaan 25
Maastricht 6229HX
NL
P. Debyelaan 25
Maastricht 6229HX
NL
Listed location countries
Age
Inclusion criteria
Skin tumor (benign or maligne) in the craniofacial area of minimaal 5mm in diameter
Excision is the therapy of choice followed by primary closure
Patients of 18 years or older
Exclusion criteria
Patients better suited for non-surgical treatment
Patients suited for excision but reconstruction by transplantation, flaps, or secundary granulation is necessary
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| ClinicalTrials.gov | NCT02125058 |
| CCMO | NL46056.068.13 |