compare the SoClose system with traditional skin wound closure with intracutaneous suturs of small skin excision on: cosmetics, wound healing, closing time, patient comfort and costs.
ID
Source
Brief title
Condition
- Skin and subcutaneous tissue therapeutic procedures
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
cosmetic result
Secondary outcome
patient comfort, surgical handling, wound infection, wound dehiscence, allergic
reaction, wound closing time and costs
Background summary
The SoClos system has recently been introduced in de dermatological surgery and
already showed promising cosmetic results, excellent comfort for the patient
during wearing and good handling characteristics for the dermatologist of
surgeon. The SoClose system consists of a adhesive sheets and a flip-over
system, which makes closing skin wounds accurate, simple and tension free.
Before surgery, the wound is covered with an incision foil, through which the
excision is made. At the end of the procedure the incision foil is removed and
the skin is closed with the flip-over strips that are situated under the
incision foil. We would like to compare the outcomes of woundhealing after
excisions of small skin lesions with conventional woundclosing, the
intracutaneous suturing with Monosyn.
Study objective
compare the SoClose system with traditional skin wound closure with
intracutaneous suturs of small skin excision on: cosmetics, wound healing,
closing time, patient comfort and costs.
Study design
A prospective multicenter cohort study
Intervention
wound closure with the SoClose system (woundfoil) instead of the conventional
intracutaneous sutures.
Study burden and risks
There are no or minimal risks involved in participation in the study. A
previous cohort study already showed that the SoClose system is a reliable and
feasible system for closing small surgical wounds and showed promising results
according to wound healing and cosmetics. Expected benefits for the patient are
better comfort during wearing of the SoClose system, improved wound healing en
better cosmetic result.
The burden of the study for the patient will include a visit the the outpatient
clinic at 14 days and 6 months after excision and fill out questionnaires a
those time points. Most patients not included in this study, also have a
protocol visit to the outpatient clinic after 14 days when sutures have to be
removes, or in follow-up after 6 months in case of a skin malignancy.
Therefore, the extra burden of participating in the study is low.
Maasstadweg 21
Rotterdam 3079 DZ
NL
Maasstadweg 21
Rotterdam 3079 DZ
NL
Listed location countries
Age
Inclusion criteria
adults, signed informed consent, skin lesion on the trunk or extremities, excision leading to a scar with margins <7.5 cm
Exclusion criteria
pregnancy, allergy to any kind of wound foil, poor comprehension of dutch language or absence of an interpreter, Moh's surgery
Design
Recruitment
Medical products/devices used
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 |
|---|---|
| CCMO | NL57665.101.16 |