Please select the arm or intervention descriptions that belong to the clinical trial below.
Title: Prevention of Seroma Formation and Wound Complications Using NPWT Devices
Brief Summary: The specific aim of this study is to improve post-operative wound care in the morbidly-obese body-contouring patient population following massive weight loss undergoing either panniculectomy or formal abdominoplasty, those patients undergoing complex abdominal wall reconstruction (i.e. ventral hernia repair) and breast reconstruction with acellular dermal matrix, as well as patients undergoing regular lipo-abdominoplasty by comparing the effectiveness of standard closed-suction drains versus the immediate application of continuous negative pressure via a NPWT (negative pressure wound therapy) device attached to non-compressible drains. Additionally, we aim to demonstrate increases both in cost-effectiveness and quality of life in these patients with the use of the NPWT wound care apparatus.

Hypothesis 1 Continuous negative pressure devices decrease the incidence of wound complications in comparison with conventional closed suction drains when used in patients after massive weight loss undergoing body-contouring procedures (panniculectomies alone and formal abdominoplasties), and in patients undergoing VHR and breast reconstruction with acellular dermal matrix, as well as those undergoing regular lipo-abdominoplasty.

Hypothesis 2 Although initially more costly than traditional closed suction drains, the use of continuous negative pressure devices will in the long-term result in lower total health care costs in the above-stated patient population due to a decreased need for additional procedures and/or clinical management, including surgical interventions, hospital admissions, administration of antibiotics, multiple follow-up office visits, and chronic wound care.

Hypothesis 3 Better quality of life is associated with the use of continuous negative pressure devices compared to closed suction drains in these patient populations.


Options:
A: Arm Label: Negative pressure wound therapy; Type: EXPERIMENTAL; Interventions: Device: Negative pressure wound therapy | Arm Label: Control; Type: ACTIVE_COMPARATOR; Interventions: Other: Micropore tape | Intervention Type: DEVICE; Name: Negative pressure wound therapy; Assigned to Arm(s): Negative pressure wound therapy | Intervention Type: OTHER; Name: Micropore tape; Assigned to Arm(s): Control
B: Arm Label: Breast Recon with acellular dermal matrix (ADM) on NPWT; Type: EXPERIMENTAL; Interventions: Device: Renasys*GO Negative Pressure Wound Therapy System | Arm Label: Lipoabdominoplasty on NPWT; Type: EXPERIMENTAL; Interventions: Device: Renasys*GO Negative Pressure Wound Therapy System | Arm Label: Abdominoplasty on NPWT; Type: EXPERIMENTAL; Interventions: Device: Renasys*GO Negative Pressure Wound Therapy System | Arm Label: Ventral Hernia Repair (VHR) on NPWT; Type: EXPERIMENTAL; Interventions: Device: Renasys*GO Negative Pressure Wound Therapy System | Arm Label: Panniculectomy on NPWT; Type: EXPERIMENTAL; Interventions: Device: Renasys*GO Negative Pressure Wound Therapy System | Arm Label: Breast Recon with ADM on Jackson-Pratt (JP) Drains; Type: NO_INTERVENTION; Interventions: N/A | Arm Label: Abdominoplasty on JP Drains; Type: NO_INTERVENTION; Interventions: N/A | Arm Label: Lipoabdominoplasty on JP Drains; Type: NO_INTERVENTION; Interventions: N/A | Arm Label: Ventral Hernia Repair (VHR) on JP Drains; Type: NO_INTERVENTION; Interventions: N/A | Arm Label: Panniculectomy on JP Drains; Type: NO_INTERVENTION; Interventions: N/A | Intervention Type: DEVICE; Name: Renasys*GO Negative Pressure Wound Therapy System; Assigned to Arm(s): Abdominoplasty on NPWT, Breast Recon with acellular dermal matrix (ADM) on NPWT, Lipoabdominoplasty on NPWT, Panniculectomy on NPWT, Ventral Hernia Repair (VHR) on NPWT
C: Arm Label: Current Standard; Type: ACTIVE_COMPARATOR; Interventions: Device: Standard Tegaderm (3M Healthcare, St. Paul, MN) adhesive dressing | Arm Label: Negative Pressure Wound Therapy; Type: EXPERIMENTAL; Interventions: Device: Prevena (Negative Pressure Wound Therapy Device) | Intervention Type: DEVICE; Name: Prevena (Negative Pressure Wound Therapy Device); Assigned to Arm(s): Negative Pressure Wound Therapy | Intervention Type: DEVICE; Name: Standard Tegaderm (3M Healthcare, St. Paul, MN) adhesive dressing; Assigned to Arm(s): Current Standard
D: Arm Label: Negative Pressure Wound Therapy; Type: EXPERIMENTAL; Interventions: Device: Negative Pressure Wound Therapy, Other: Usual Care of Surgical Wound | Arm Label: Usual Care of Surgical Wound; Type: ACTIVE_COMPARATOR; Interventions: Other: Usual Care of Surgical Wound | Intervention Type: DEVICE; Name: Negative Pressure Wound Therapy; Assigned to Arm(s): Negative Pressure Wound Therapy | Intervention Type: OTHER; Name: Usual Care of Surgical Wound; Assigned to Arm(s): Negative Pressure Wound Therapy, Usual Care of Surgical Wound

Answer: B