“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”

Abstract

Background: In breast reconstruction operations, surgical wound dehiscence is a serious complication that generates a significant burden on patients and health care systems. There are indications that postoperative treatment with closed-incision negative-pressure therapy has been associated with reduced wound dehiscence rates. This randomized clinical trial examines the effect of closed-incision negative-pressure application on abdominal donor-site surgical wound dehiscence in low- and high-risk patients undergoing breast reconstruction with a deep inferior epigastric perforator flap. Methods: Eighty eligible women, stratified as low- or high-risk patients, were included and were randomized for treatment with either closed-incision negative-pressure or adhesive strips by drawing sealed, opaque envelopes. All surgeons were kept blinded for allocation. Primary outcomes were surgical wound dehiscence and surgical-site infection at the abdominal donor site on follow-up after 12 weeks. Secondary outcomes were seroma and hematoma formation. Five patients were excluded from the study because of insufficient 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 closed-incision negative-pressure (n = 36) or adhesive strips (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 percent; 95 percent CI, 1.5 to 41.7 percent). No statistically significant differences were found in surgical-site infection or secondary outcomes. Conclusion: In this randomized clinical trial, postoperative treatment with closed-incision negative-pressure therapy decreased the incidence of surgical wound dehiscence at the abdominal donor site in low- and high-risk deep inferior epigastric perforator flap breast reconstruction patients. CLINICAL QUESTION/LEVEL OF EVIDENCE: Therapeutic, I.

Influence of Closed-incision Negative Pressure Wound Therapy on Abdominal Site Complications in Autologous Breast Reconstruction

“…Wound dehiscence has been shown to cause significant morbidity, including decreased patient quality of life, prolonged hospital stays, and increased care costs. 17,27,[31][32][33][34][35][36][37][38][39][40][41][42] Our finding is congruent with other studies examining ciNPWT in orthopedic trauma, 5,43 breast surgery, 11,14,15,44 abdominal wall reconstruction, 34,45 laparotomy, 46,47 ventral hernia repair, 48 and reviews combing multiple types of procedures. 36,41,45,[49][50][51][52] However, results in the literature are mixed, and other studies do not show this relationship.…”

“…78 In addition, wound dehiscence and infection often occur together and are often reported alone even when they are both present. 27,33,38 Our findings on seroma rates were similarly not statistically significant (P = 0.63). Some studies demonstrate a benefit on rates of seroma with the use of ciN-PWT, 11,41,44,49,50,52,54,55,63 but results are mixed.…”

“… 78 In addition, wound dehiscence and infection often occur together and are often reported alone even when they are both present. 27 , 33 , 38 …”

“…Of the eight studies included, six were retrospective cohorts, [19][20][21][22]25,26 one was a retrospective case-control, 24 and one was a single-blinded, randomized clinical trial. 27 Data on 1009 patients were reported, and data on surgery type were corroborated in seven of the studies. Of the 578 patients in the seven studies, 527 underwent DIEP, 28 underwent MS-TRAM, and 23 underwent DIEP/MS-TRAM.…”

Clinical and Oncologic Safety in Modern Breast Reconstruction

“…Outside the breast, donor-site complications may slow an otherwise uneventful recovery. In a randomized controlled trial with 75 women, Muller-Sloof et al 10 show that closed-incision negative-pressure therapy decreases wound dehiscence.…”