BandGrip® Closure of Surgical Incisions Following Arthroscopic Surgery

The study objective is to assess the ease of incision closure, the cosmetic appearance of the
wounds on follow-up, and general subject satisfaction with the appearance of the healed
incisions following use of BandGrip. Up to 25 subjects will be enrolled at a single center.

Subjects who have undergone arthroscopic surgery of the shoulder and require closure of one
or two skin puncture sites will be enrolled. Following incision closure subjects will be seen
at the time of BandGrip removal (approximately 7-14 days after closure) and at 30 days for
assessment of the incisions.

The incidence of wound closure for each treated puncture site, defined as continuous
approximation of wound margins from the time of wound closure until the day of removal of the
wound closure device without dehiscence or need for reclosure.

Inclusion Criteria:

- 1. Subject is ≥ 18 years of age. 2. Subject had an arthroscopic shoulder procedure and
has at least two skin incisions that are assessed as requiring temporary approximation
of the skin edges.

3. The length of the subject's surgical incisions is less than or equal to 1.5 inches.

4. Subject must be willing to follow instructions for wound care provided by
investigator and refrain from picking at the treatment device, applying topical
medications to the wound, and swimming or soaking in a tub until the wound closure
device is removed.

5. Subject agrees to return for all required follow-up evaluations. 6. Subject is able
to comprehend and give informed consent for participation in this study.

Exclusion Criteria:

- 1. Subject has a recent history of bleeding, coagulation, and/or clotting disorders.

2. Subject is on dialysis. 3. Subject has a history of inflammatory and/or allergic
diseases or conditions of the skin involving the location of the incisions (e.g.,
psoriasis, Eczema, or dermatitis).

4. Subject has a history of drug abuse. 5. Subject has a history of chronic use of
oral steroids or immunosuppressants. 6. Subject has known personal or family history
of keloid or hypertrophic scarring.

7. Subject has a history of abnormal wound healing. 8. Subject's incisions are in a
high skin tension area. 9. Subject has a known allergy to BandGrip material
(polycarbonate). 10. Subject has a known cognitive or psychiatric disorder. 11.
Subject has an incision at site of active rash/skin lesion making evaluation
difficult.