Comparing the OptiClose® System with traditional skin wound closure with intracutaneous sutures on wound closing time, patient comfort, cosmetic results, surgical handling, and costs.
ID
Source
Brief title
Condition
- Tissue disorders NEC
- Skin and subcutaneous tissue therapeutic procedures
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Wound closure time.
Costeffectiveness
Secondary outcome
Patient comfort
Cosmetic results
Background summary
The OptiClose® System has been introduced recently in dermatological surgeries
and showed a good cosmetic result, excellent wearing comfort for the patient
and good handling characteristics for the surgeon. We would like to compare the
characteristics (reduced operating time and increased patient comfort) of the
OptiClose® System after median sternotomy.
Study objective
Comparing the OptiClose® System with traditional skin wound closure with
intracutaneous sutures on wound closing time, patient comfort, cosmetic
results, surgical handling, and costs.
Study design
Prospective randomized controlled pilot study
Intervention
In one group the skin wound after median sternotomy is closed by intracutaneous
sutures and in the other group the skin is closed with the OptiClose® System.
Study burden and risks
There are no risks involved in participation in the study. Expected benefits
for the patient are better cosmetic result of the scar and an increase of
patient comfort during wearing the OptiClose® System.
Dr. Molewaterplein 50
Rotterdam 3015 GE
NL
Dr. Molewaterplein 50
Rotterdam 3015 GE
NL
Listed location countries
Age
Inclusion criteria
* Adult patients (*18 year);
* Signed informed consent;
* Patients undergoing median sternotomy.
Exclusion criteria
* Current pregnancy;
* Allergy to any kind of wound foil;
* Previous median sternotomy;
* Future planned median sternotomy within 3 months;
* Poor comprehension of Dutch or absence of an interpreter
Design
Recruitment
Medical products/devices used
metc-ldd@lumc.nl
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In other registers
| Register | ID |
|---|---|
| CCMO | NL42487.058.13 |