Treatment of surgical scars in breast reduction with laser device, to prevent scar hypertrophy.

Every trauma or surgery leaves a scar in the skin. Even thorough surgery and
meticulous stitching can not prevent the formation of excessive scarring in
predisposed individuals. It is thought that the kind of immune reaction
influences the scar formation and can give them a raised and red appearance as
seen in burn wounds. Patients often seek help to improve the functional and
cosmetic impairments due to the excessive scarring.

There are indications that early laser treatment of wounds can reduce scar
formation. With the laser device the wound will be heated, which is thought to
be responsible for a reduced inflammatory reaction and hence for a reduced scar
formation. The purpose of this study is to determine whether treatment of
surgical wounds directly after closure with the EkkyLite* laser system will
improve clinical and cosmetic appearance relative to untreated wounds in women
who undergo breast reduction surgery.

In this study the cosmetic and physical appearance of scars are evaluated in
patients undergoing breast reduction surgery. Wounds treated with laser therapy
with the EkkyLite system are compared with untreated wounds within the same
subject. The study is a prospective, randomized, controlled, left-right
comparison study.
The enrollment period is 1 year and the follow-up period is 1 year.
Patients are randomly assigned to one of two treatment groups:
Group 1: Laser treatment of right lateral and left medial infra-mammary scar
Group 2: Laser treatment of left lateral and right medial infra-mammary scar

The laser treatment that will be assessed in this study will be used at the end
of the surgical operation only, directly after closure of the surgical wound.
Breast reduction surgery is performed exactly as is customary. The wound is
closed with the normal sutures; Monocryl® 3.0 subcutaneously and Monocryl® 4.0
intra-cutaneously. After closure a part of the surgical wounds at the underside
of both breasts (left and right) will be treated with the EkkyLiteTM laser
device. Which part exactly is treated shall be decided by randomization.
The laser beam will be applied spot-by-spot. The power and duration of the
laser shots, which have to correspond to the size of the spot used (20x4 mm),
will be adjusted.
Fluence will be adjusted to patient skin phototype:
* 110J/cm² to skin phototype I to III (shot duration of 13 seconds)
* 85J/cm² to skin phototype IV (shot duration of 10) seconds

The risk of the treatment is very small. No adverse effects of the treatment
have been reported yet. The possibility of overheating (burning) of the tissue
are prevented by the system itself. Treatment and follow-up is as normal. The
effectiveness of the EkkyLiteTM laser has been demonstrated in breast
enlargement surgery and abdominal surgery. However, scientific evidence that
excessive hypertrophic scar tissue formation is prevented by laser treatment
with the EkkyLiteTM device is still lacking, it can not be assumed on forehand
that the patient will benefit from the treatment. The only extra burden for the
patient is the time invested for filling in questionnaires at four follow-up
time points.