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"Closed Incision Negative Pressure Therapy (ciNPT) reduces abdominal donor site surgical wound dehiscence in Deep Internal Epigastric Perforator (DIEP) flap breast reconstructions: DEhiscence PREvention Study II (DEPRES II) - a Randomized Clinical Trial".

BACKGROUND
In breast reconstruction surgeries, surgical wound dehiscence is a serious complication which generates a significant burden on patients and healthcare systems. There are indications that postoperative treatment with closed incision negative pressure therapy (ciNPT) has been associated with reduced wound dehiscence rates. This randomized clinical trial examines the effect of ciNPT application on abdominal donor site surgical wound dehiscence in low- and high-risk patients undergoing a breast reconstruction with a deep internal epigastric perforator (DIEP) flap.


METHODS
Eighty eligible women, stratified as low- or high-risk patients, were included and were randomized for treatment with either ciNPT or adhesive strips (AS) by drawing sealed, opaque envelopes. All surgeons were kept blind for allocation. Primary outcomes were surgical wound dehiscence and surgical site infection at the abdominal donor site upon follow-up after 12 weeks. Secondary outcomes were seroma and hematoma formation. Five patients were excluded from the study due to non-sufficient exposure to the study treatment (n=4) or major protocol deviation (n=1).


RESULTS
A total of 75 women, low-risk (n=38) and high-risk (n=37), received either ciNPT (n=36) or AS (n=39). Patients' demographics did not differ significantly. Donor-site surgical wound dehiscence occurred in 23 patients; the Absolute Risk Reduction was statistically significant (21.6%, 95% Confidence Interval [1.5-41.7]). No statistically significant differences were found in surgical site infection or secondary outcomes.


CONCLUSIONS
In this randomized clinical trial, postoperative treatment with ciNPT decreased the incidence of surgical wound dehiscence at the abdominal donor site in low- and high-risk DIEP flap breast reconstruction patients.