Incisional Negative Pressure Wound Therapy in High Risk Patients Undergoing Panniculectomy: A Prospective Randomized Controlled Trial
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|ClinicalTrials.gov Identifier: NCT03010137|
Recruitment Status : Terminated (Lack of staff resources to properly consent and enroll patients into the study.)
First Posted : January 4, 2017
Results First Posted : June 9, 2020
Last Update Posted : June 9, 2020
|Condition or disease||Intervention/treatment||Phase|
|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||Procedure: Incisional Negative Pressure Wound Therapy Procedure: Standard Closure with Skin Glue Device: PICO (Smith&Nephew) Device: Dermabond||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||30 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Incisional Negative Pressure Wound Therapy in High Risk Patients Undergoing Panniculectomy: A Prospective Randomized Controlled Trial|
|Study Start Date :||December 2015|
|Actual Primary Completion Date :||March 13, 2019|
|Actual Study Completion Date :||March 13, 2019|
Placebo Comparator: Standard Closure
After surgical closure is complete, the patient receives standard of care operative incision treatment (dermabond/topical skin adhesive).
Procedure: Standard Closure with Skin Glue
Final wound closure with skin glue.
Active Comparator: Incisional Negative Pressure Wound Therapy
After surgical closure is complete, an incisional negative pressure wound therapy device is applied to the incision in its entirety. This device is placed on the wound, sterilely, in the operating room, at the conclusion of the procedure. The incisional negative pressure wound therapy device is to remain in place for 7 days, and is removed in clinic after completion.
Procedure: Incisional Negative Pressure Wound Therapy
Device: PICO (Smith&Nephew)
Off the shelf, disposable negative pressure wound therapy device. Contains sterile dressing as well as an attached small (pager sized) suction device/canister.
- Major Wound Healing Complications [ Time Frame: Up to 3 months after operation ]Abscess, Hematoma or any wound complication requiring return to the operating room.
- Minor Wound Healing Complications [ Time Frame: Up to 3 months after operation ]Cellulitis, Seroma, Superficial Wound Separation
- Time to Drain Removal [ Time Frame: Up to 3 months after operation ]Time to final drain removal after the operation
- Scarring [ Time Frame: data not collected due to early termination ]Will assess using Vancouver Scar Scale
- Pain Score Self Reported by the Patient After Surgery [ Time Frame: data not collected due to early termination ]Assess via a visual analog scale at specified intervals
- Quality of Life as Measured by SF-36 Validated Survey [ Time Frame: data not collected due to early termination ]Assess via SF-36 validated survey at specified intervals
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03010137
|United States, California|
|University of California, Davis Medical Center|
|Sacramento, California, United States, 95817|
|Principal Investigator:||Michael S Wong, MD||University of California, Davis|