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BandGrip® Closure of Surgical Incisions Following Arthroscopic Surgery

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ClinicalTrials.gov Identifier: NCT03644316
Recruitment Status : Completed
First Posted : August 23, 2018
Last Update Posted : July 10, 2019
Sponsor:
Information provided by (Responsible Party):
BandGrip

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

Condition or disease Intervention/treatment Phase
Surgical Incision Device: BandGrip skin closure device Not Applicable

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.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 25 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: BandGrip® Closure of Surgical Incisions Following Arthroscopic Surgery
Actual Study Start Date : June 26, 2018
Actual Primary Completion Date : August 30, 2018
Actual Study Completion Date : October 30, 2018

Arm Intervention/treatment
Experimental: BandGrip
Topical skin closure device
Device: BandGrip skin closure device
topical skin closure device




Primary Outcome Measures :
  1. Incidence of complete would closure [ Time Frame: 30 days post treatment ]
    complete 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.


Secondary Outcome Measures :
  1. Incidence of partial wound apposition [ Time Frame: 10 and 30 days post closure ]
    at least 50% wound apposition

  2. Incision Cosmesis [ Time Frame: 10 and 30 days post closure ]
    use of a 0 to 100 mm visual analog scale (100mm is best outcome)

  3. Subject Satisfaction with cosmetic appearance of healed incision [ Time Frame: 10 and 30 days post surgery ]
    use of a 0 to 100mm visual analog scale (100mm is best outcome)

  4. Physician Satisfaction with cosmetic appearance of healed incision [ Time Frame: 10 and 30 days post surgery ]
    use of a 0 to 100mm visual analog scale (100mm is best outcome)

  5. Time to closure and removal of wound closure device [ Time Frame: at surgical procedure and 10 days ]
    amount of time to apply and remove BandGrip

  6. Adverse events [ Time Frame: 30 days post surgery ]
    collection of device complaints



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03644316


Locations
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United States, Iowa
Mercy Medical Center
Des Moines, Iowa, United States, 50314
Sponsors and Collaborators
BandGrip
Investigators
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Principal Investigator: Kyle Galles, MD Mercy Medical Center

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Responsible Party: BandGrip
ClinicalTrials.gov Identifier: NCT03644316     History of Changes
Other Study ID Numbers: OPS-002
First Posted: August 23, 2018    Key Record Dates
Last Update Posted: July 10, 2019
Last Verified: July 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: No
Pediatric Postmarket Surveillance of a Device Product: No
Product Manufactured in and Exported from the U.S.: No

Additional relevant MeSH terms:
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Surgical Wound
Wounds and Injuries