Surgical Wound Dehiscence

Conducting clinical research in line with the literature recommendation, with a method that is low-cost, accessible, easy-to-use, and examined in an evidence-based design related to cesarean section wound, which negatively affects the quality of life of women in the postpartum period, constitutes the original value and our main motivation of the project.

In women who undergo mastectomy for the treatment of breast cancer, autologous reconstruction using the deep inferior epigastric perforator (DIEP) flap is a common surgical procedure that aims to restore both the appearance and texture of the breast(s).Specifically, this requires the transfer of skin, fat, and perforator vessels from the abdomen to a recipient artery and vein in the chest to create a viable breast mound. Post-operatively, the abdominal donor site is routinely monitored for wound dehiscence, which has a reported incidence of up to 39% in this patient population; however, this incidence typically varies from 3.5% to 14%.
At the investigators' academic institution, patients who undergo DIEP breast reconstruction typically have ciNPT or traditional tape dressings applied to the closed abdominal donor site. These dressings are selected according to surgeon preference and typically remain in-situ until hospital discharge. As there remains clinical equipoise regarding the ability of ciNPT to reduce abdominal wound dehiscence, further research in the form of a parallel, two-arm RCT is warranted.
The investigators propose a randomized controlled superiority trial with the primary objective of comparing the incidence of wound dehiscence at 1 month in patients undergoing autologous DIEP breast reconstruction with ciNPT versus standard tape dressings for the abdominal donor site incision. The design and conduct of the proposed study will mirror the methodology of the recently completed pilot trial (NCT04985552) including randomization, interventions, and clinical outcomes.
The secondary objective of this study is to evaluate other clinical outcomes comparing ciNPT to standard tape dressings applied to the abdominal donor site incision. Secondary clinical outcomes will include: 2) the incidence of seroma formation and surgical site infection at 1 month; 2) quality of life as measured by BREAST-Q physical well-being abdomen and EQ-5D-5L pre-operatively, 1-month, 3-months, and 6-months postoperatively; 3) Scar appearance as measured by the SCAR-Q at 1-month, 3-months, and 6-months postoperatively.
As an adjunct to the main study, another secondary clinical outcome will include the overall incidence of MINS as diagnosed by postoperative abnormally elevated troponin levels (as per site-specific laboratory assay thresholds) and electrocardiograms (ECG) at 6-12 hours and 1, 2, and 3 days after surgery.

Mediastinitis is the most feared infectious complication after cardiac surgery. Several risk factors are known such as: obesity, diabetes, chronic obstructive pulmonary disease, double breast sampling, immunodeficiency, corticosteroid therapy, reoperation, chest radiotherapy, and dialysis. Three modes of contamination are described: intraoperative contamination, hematogenous dissemination during sepsis, gradual contamination from cutaneous dehiscence. It is important and simple to fight against this third mode. The dehiscence of the sternotomy scar represents a gateway and facilitates bacterial colonization and is a risk factor for infection of the surgical site. These skin disunities lead to an increase in health care costs due to extension of hospital stay, the cost of repeated nursing care, surgical revision, and the need for increased follow-up. They delay cardiac rehabilitation and return home. It is estimated that these simple disunities occur in more than 15% of cases, although fortunately they rarely result in mediastinitis. While the use of NPWT for the prevention of wound healing complications is permitted, its benefit has not been demonstrated. Its action is multiple with a reduction in the rate of repair of dressings and therefore of soiling, drainage of the wound, limitation of maceration, acceleration of healing. The use of NPWT as a dressing for sternotomies could prevent skin breakdown, and therefore superficial and deep surgical site infections.
Two types of NPWT devices exist, corresponding to 2 different types of treatment: the 7-day NPWT without dressing repair but with reservoir (PREVENA®), the NPWT with 3-day repair without reservoir (PICO®).
Given the cost and widespread use of NPWT for chirurgical site infection prophylaxis, it is important to conduct randomized trials to assess the expected benefit of these NPWTs designed for use on clean, closed surgical incisions. In cardiac surgery, its benefit has only been shown in a high-risk population: surgery for Coronary Artery Bypass Graft (CABG).
The present clinical investigation will be the first randomized, multicenter trial comparing the efficacy and safety of NPWT versus standard dressing in preventing the risk of scar dehiscence after cardiac surgery, in a standard population.
The patients will be followed for 90 days (3 months).