Port Wound Closure compares synthetic tissue adhesives with seam for cutaneous wound closure to port plant in terms of cosmetic results and time savings at comparable risk for wound infection.
Study patients who undergo a subcutaneous venous port implant procedure are randomized into control group (conventional sutures) or into interventional group (synthetic tissue adhesive). The intervention time is documented. Follow-up visit is performed 8 weeks after port implantation. It includes a photo documentation, quality of life questionnaire (EQ5D) and pain scala questionnaire (POSAS) by patient and by 3 independent observers as well as the documentation of complications.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
128
Skin incision closure with standard subcuticular technique
Skin incision closure with topic skin adhesive Histoacryl® Flexible (n-Butyl-2-Cyanoacrylate Monomer)
University Hospital Jena
Jena, Thuringia, Germany
Cosmetic outcome after wound healing
Wound assessment by 3 independent evaluators (surgeons) and patient himself based on photo documentation
Time frame: 8 weeks
Cosmetic outcome after wound healing
Patient and observer scar assessment scale (POSAS)
Time frame: 8 weeks
Cosmetic outcome after wound healing
Life quality questionnaire EQ5D
Time frame: 8 weeks
Infection rate
Assessment of adverse events through AE documentation based on the adverse impact of surgical site infections (German: CDC Kriterien)
Time frame: 8 weeks
Economy of time for wound closure
Time measurement by stopwatch and exact documentation of intervention time of subcutaneous suture and skin closure time
Time frame: 10 minutes
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