Standard wound closure with/without incisional negative pressure wound therapy (INPWT) in high risk patients having panniculectomy

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"Is surgical wound healing complications, pain, and scarring improved with incisional negative pressure wound therapy (INPWT)?"
Age:
18 to 100 years old
Gender:
Any
Healthy Volunteers:
No
Keywords:
wound, obese, panniculectomy, surgery, kidney transplant
Type:
Procedure study
Investigator:
Description
The purpose of this study is to determine how well standard wound closure compared to standard wound closure and incisional negative pressure wound therapy performs in regards to wound healing complications, pain and scarring. Incisional negative pressure therapy (INPWT) has previously been shown to decrease wound healing complications in certain patient populations. We have found a group of patients, those who have panniculectomies in preparation for renal transplant, experience significantly higher rates of wound healing complications. We believe the best way to demonstrate benefits of incisional negative pressure wound therapy will be in this group of patients known to have significantly higher rates of wound complications. This study will compare 1) the rate of wound healing complications between the two groups, 2) the time to drain removal as well as 3) the scar quality, amount of postoperative pain and quality of life experienced between the two groups. This is a randomized study, meaning that patients will be randomly assigned to the control or test groups. Neither you nor your surgeon will pick which group you are assigned to. You must be willing to have either closure method performed to participate in this study
This study requires
Medical history and questionnaires
Surgery: panniculectomy with incisional negative pressure wound therapy, or
panniculectomy with standard skin closure
Follow up clinical visits (variable)
Questionnaires mailed to home
Who can participate?
Inclusion Criteria:

- All patients undergoing panniculectomy in preparation for renal transplantation at the University of California Davis Medical Center. Patients who are entered into the trial and have 30 days of follow up, and those in the INPWT study arm who successfully complete 7 days of treatment, will be included.


Exclusion Criteria:

- All patients who previously demonstrated a hypersensitivity reaction to adhesives and qualify for panniculectomy in preparation for renal transplantation, or all patients who are undergoing panniculectomy for reasons other than in preparation for renal transplantation (i.e. after massive weight loss or for cosmetic reasons). Patients who do not complete the duration of treatment of negative pressure wound therapy (7 days), or patients who do not follow up for a minimum of 30 days from the date of surgery will be excluded. Adults unable to consent, infants, children, teenagers, pregnant patients and prisoners will be excluded. It is also extremely unlikely, based on our study population, that we will encounter any of these patients.
Resources
Schedule
Study duration and period
Approximately 6 months
Recruitment period
From Dec. 22, 2015
Location
UC Davis Plastic and Reconstructive Surgery
3301 C Street
Suite 1100
Sacramento, CA 95816
Contact
Chad Bailey, MD
Research Topic
Conditions:
  • Complications Wounds
  • Negative Pressure Wound Therapy
  • Wound Healing Delayed
  • Incisional
  • Panniculectomy
  • Incisional Negative Pressure Wound Therapy
  • Incisional Vac
  • Wound Vac
  • Obese
  • Renal Failure
  • Kidney Transplant; Complications
  • Wound Healing Complication

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