BandGrip® Closure of Surgical Incisions Following Arthroscopic Surgery
Completed · Not applicable
Conditions studied: Surgical Incision
In brief
A single-arm, prospective, unblinded, post marketing, single center study using BandGrip to close incisions post arthroscopic shoulder surgery.
Key facts
- Study ID
- NCT03644316
- Run by
- BandGrip
- People needed
- 25
- Starts
- 2018-06-26
- Expected to finish
- 2018-10-30
- Last updated by the study team
- 2019-07-10
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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.
- The length of the subject's surgical incisions is less than or equal to 1.5 inches.
- 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.
- 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.
You may not qualify if…
- 1. Subject has a recent history of bleeding, coagulation, and/or clotting disorders.
- 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).
- 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.
- 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.
Where it is running
- Mercy Medical Center — Des Moines, Iowa, United States
Full record on ClinicalTrials.gov
Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.