Prevention of Seroma Formation and Wound Complications Using NPWT Devices
Seroma, Wound Dehiscence, Wound Infection
About this trial
This is an interventional prevention trial for Seroma
Eligibility Criteria
Inclusion Criteria:
- 30 total patients undergoing panniculectomy alone following massive weight loss
- 30 total patients undergoing formal abdominoplasty (including undermining of skin flaps, rectus fascia plication and liposuction) following massive weight loss
- 30 total non-massive weight loss patients undergoing formal lipo-abdominoplasty
- 30 total patients undergoing ventral hernia repair using acellular dermal matrix
- 30 total patients undergoing bilateral breast reconstruction using acellular dermal matrix with 30 breasts randomized to conventional closed suction (one breast left vs right) and 30 breasts randomized to continuous negative pressure devices (=60 breasts total)
Exclusion Criteria:
- presence of necrotic tissue
- untreated osteomyelitis
- malignancy (except terminal patients for quality of life issues)
- untreated malnutrition
- use on exposed arteries, veins, or organs
- use on non-enteric and unexplored fistulas Special precaution will be taken when using the NPWT device in patients on anticoagulants, exhibiting otherwise difficult hemostasis, or non-adherent patients.
Sites / Locations
- Yale University School of Medicine
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm 5
Arm 6
Arm 7
Arm 8
Arm 9
Arm 10
Experimental
Experimental
Experimental
Experimental
Experimental
No Intervention
No Intervention
No Intervention
No Intervention
No Intervention
Breast Recon with acellular dermal matrix (ADM) on NPWT
Lipoabdominoplasty on NPWT
Abdominoplasty on NPWT
Ventral Hernia Repair (VHR) on NPWT
Panniculectomy on NPWT
Breast Recon with ADM on Jackson-Pratt (JP) Drains
Abdominoplasty on JP Drains
Lipoabdominoplasty on JP Drains
Ventral Hernia Repair (VHR) on JP Drains
Panniculectomy on JP Drains
The Smith&Nephew Renasys*GO device connected to non-compressible drains will be applied to the lipoabdominoplasty patients enrolled in this arm.
The Smith&Nephew Renasys*GO device connected to non-compressible drains will be applied to the abdominoplasty patients enrolled in this arm.
The Smith&Nephew Renasys*GO device connected to non-compressible drains will be applied to the VHR patients enrolled in this arm.
The Smith&Nephew Renasys*GO device connected to non-compressible drains will be applied to the panniculectomy patients enrolled in this arm.
Standard of Care. The Jackson-Pratt (JP) drain is used following surgery to collect bodily fluids from the surgical site.
Standard of Care. The Jackson-Pratt (JP) drain is used following surgery to collect bodily fluids from the surgical site.
Standard of Care. The Jackson-Pratt (JP) drain is used following surgery to collect bodily fluids from the surgical site.
Standard of Care
Standard of care. The Jackson-Pratt (JP) drain is used following surgery to collect bodily fluids from the surgical site.