Clinical trial NCT03644316: BandGrip® Closure of Surgical Incisions Following Arthroscopic Surgery
Official title: BandGrip® Closure of Surgical Incisions Following Arthroscopic Surgery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Surgical Incision
Lead sponsor: BandGrip
Sponsor class: INDUSTRY
First posted: 2018-08-23
Enrollment: 25
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: A single-arm, prospective, unblinded, post marketing, single center study using BandGrip to close incisions post arthroscopic shoulder surgery.

Detailed description: 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Incidence of complete would closure
timeFrame: 30 days post treatment
Secondary outcomes:
measure: Incidence of partial wound apposition
timeFrame: 10 and 30 days post closure
measure: Incision Cosmesis
timeFrame: 10 and 30 days post closure
measure: Subject Satisfaction with cosmetic appearance of healed incision
timeFrame: 10 and 30 days post surgery
measure: Physician Satisfaction with cosmetic appearance of healed incision
timeFrame: 10 and 30 days post surgery
measure: Time to closure and removal of wound closure device
timeFrame: at surgical procedure and 10 days
measure: Adverse events
timeFrame: 30 days post surgery
Other outcomes:
Locations:
city: Des Moines
country: United States
facility: Mercy Medical Center
state: Iowa
Study officials:
affiliation: Mercy Medical Center
name: Kyle Galles, MD
role: PRINCIPAL_INVESTIGATOR
References: