Randomized Single-Center Study of Effectiveness and Safety of a Resorbable Lysine-Based Urethane Adhesive for a Drain-Free Closure of the Abdominal Donor Site in a DIEP Flap Breast Reconstruction Procedure.

Autor: Fertsch S; Department of Plastic Surgery, SANA Clinic Düsseldorf Gerresheim, Düsseldorf, Germany.; Department of Health, University of Witten, Herdecke, Germany., Michalak M; Department of Computer Science and Statistics, Poznan University of Medical Sciences, Poznan, Poland., Andree C; Department of Plastic Surgery, SANA Clinic Düsseldorf Gerresheim, Düsseldorf, Germany., Munder B; Department of Plastic Surgery, SANA Clinic Düsseldorf Gerresheim, Düsseldorf, Germany., Hagouan M; Department of Plastic Surgery, SANA Clinic Düsseldorf Gerresheim, Düsseldorf, Germany., Schulz T; Department of Plastic Surgery, SANA Clinic Düsseldorf Gerresheim, Düsseldorf, Germany., Stambera P; Department of Plastic Surgery, SANA Clinic Düsseldorf Gerresheim, Düsseldorf, Germany., Steammler K; Department of Plastic Surgery, SANA Clinic Düsseldorf Gerresheim, Düsseldorf, Germany., Grueter L; Department of Plastic Surgery, SANA Clinic Düsseldorf Gerresheim, Düsseldorf, Germany., Kornetka J; Department of Plastic Surgery, SANA Clinic Düsseldorf Gerresheim, Düsseldorf, Germany., Wolter A; Department of Plastic Surgery, SANA Clinic Düsseldorf Gerresheim, Düsseldorf, Germany.; Department of Health, University of Witten, Herdecke, Germany.
Jazyk: angličtina
Zdroj: Journal of investigative surgery : the official journal of the Academy of Surgical Research [J Invest Surg] 2022 Jun; Vol. 35 (6), pp. 1404-1414. Date of Electronic Publication: 2022 Mar 09.
DOI: 10.1080/08941939.2022.2046215
Abstrakt: Objective: The hypothesis of this parallel group randomized trial testifies if TissuGlu is a safe and an effective alternative to the conventional drainage placement in regard to post-operative fluid management in the abdominal donor site for autologous (DIEP flap) breast reconstruction with a higher postoperative patient quality of life.
Patients and Methods: Data was collected for 58 women who required to be at min.18 years old with a BMI < 30 and not taking any SSRIs (Selective Serotonin Reuptake Inhibitors).Exclusion criteria: Discharge with indwelling suction drains at the abdominal site or signs of wound infection during hospital stay.The patients were randomized into a study group (donor site closure with application of surgical adhesive without drains) and a control group (donor site closure with drains) using a randomly sorted sealed envelope system.Th e primary outcome was defined as the number of post-operative seroma formations.The secondary endpoint was the evaluation of patient satisfaction with both methods.
Results: 58 patients underwent a DIEP reconstruction (29 in the control- and 29 in the study group).Both groups were homogenous. Rate of seroma was 17%(5/29) in the study group and 10%(3/29) in the control group which showed no statistical significance (p-value = 0.71).Smoking and previous abdominal surgery turned out to be a risk factor for seroma formation in the study group.Overall satisfaction was evaluated with a questionnaire and was higher in the study group.
Conclusion: The abdominal closure with the surgical adhesive seems to be a safe procedure that contributes to patient satisfaction and increases the independence upon discharge in patients with adequate inclusion criteria.
Databáze: MEDLINE
Externí odkaz:
Nepřihlášeným uživatelům se plný text nezobrazuje