Wound Closure After Port Implantation-A Randomized Controlled Trial Comparing Tissue Adhesive and Intracutaneous
Saskia Witting1, Maja Ingwersen, Thomas Lehmann
1Department of Radiology, Jena University Hospital, Friedrich Schiller University of Jena; Institute for Medical Statistics, Computer Science and Data Science Jena, Jena University Hospital, Jena; Department of General, Visceral and Vascular Surgery, Jena University Hospital, Friedrich-Schiller-University Jena; Department of Trauma-, Handand Reconstructive Surgery, University Hospital Jena, Friedrich-Schiller-University Jena; Department of Dermatology, University Hospital Jena, Friedrich-Schiller-University Jena.
Background:
Wound healing after pectoral port implantation is a major factor determining the success or failure of the procedure. Infection and wound dehiscence can endanger the functionality of the port system and impede chemotherapy. The cosmetic result is important for patient satisfaction as well.
Methods:
From August 2015 to July 2017, adult patients with an indication for port implantation were entered into a prospective, randomized and controlled single-center study. The skin incision was closed either with tissue adhesive or with an intracutaneous suture. The primary endpoints were the total score of the scar evaluated by the patient and the investigator on the POSAS scale (Patient and Observer Scar Assessment Scale: 6 [normal skin] to 60 points), blinded assessment of photographic documentation by ten evaluating physicians, and the patient's reported quality of life. The calculation of case numbers was based only on the patients' overall POSAS assessment, which was tested for non-inferiority. The secondary endpoints were other complications (infection, dehiscence) and the duration of wound closure (trial registration number NCT02551510).
Results:
156 patients (60 ± 13 years, 64% women) participated in the study. The patient-assessed total POSAS score of tissue adhesive revealed non-inferiority to suturing (adhesive 11.7 ± 5.8 vs. suture 10.1 ± 4.0, p for non-inferiority <0.001). Both the investigators in their POSAS assessments and the blinded physician evaluators in their assessment of photographically documented wounds rated wound closure by suturing better than closure with tissue adhesive. No significant differences were found between groups with respect to quality of life or the frequency of wound infection or dehiscence.
Conclusion:
Closure of the upper cutaneous layer with tissue adhesive is a suitable and safe method of wound closure after port implantation.
