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

Abstract

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.

Keywords:

• DIEP Flap
• autologous breast reconstruction
• tissue glue
• surgical adhesive
• seroma

View addendum:

Tissue Adhesive: Current Uses and Strengths

Acknowledgments

We thank Andrea Alexa Hernandez for editing the manuscript.

Disclosure statement

No potential conflict of interest was reported by the author(s).

Level of evidence

Level IV: Evidence obtained from multiple time series with or without the intervention, such as case studies. Dramatic results in uncontrolled trials might also be regarded as this type of evidence.