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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

Tracking Information
First Submitted Date  ICMJE August 20, 2018
First Posted Date  ICMJE August 23, 2018
Last Update Posted Date July 10, 2019
Actual Study Start Date  ICMJE June 26, 2018
Actual Primary Completion Date August 30, 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 21, 2018)
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.
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT03644316 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: August 21, 2018)
  • Incidence of partial wound apposition [ Time Frame: 10 and 30 days post closure ]
    at least 50% wound apposition
  • Incision Cosmesis [ Time Frame: 10 and 30 days post closure ]
    use of a 0 to 100 mm visual analog scale (100mm is best outcome)
  • 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)
  • 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)
  • 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
  • Adverse events [ Time Frame: 30 days post surgery ]
    collection of device complaints
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE BandGrip® Closure of Surgical Incisions Following Arthroscopic Surgery
Official Title  ICMJE BandGrip® Closure of Surgical Incisions Following Arthroscopic Surgery
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Surgical Incision
Intervention  ICMJE Device: BandGrip skin closure device
topical skin closure device
Study Arms  ICMJE Experimental: BandGrip
Topical skin closure device
Intervention: Device: BandGrip skin closure device
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: August 21, 2018)
25
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE October 30, 2018
Actual Primary Completion Date August 30, 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.

Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03644316
Other Study ID Numbers  ICMJE OPS-002
Has Data Monitoring Committee No
U.S. FDA-regulated Product
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
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party BandGrip
Study Sponsor  ICMJE BandGrip
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Kyle Galles, MD Mercy Medical Center
PRS Account BandGrip
Verification Date July 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP