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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
Sponsor:
Information provided by (Responsible Party):
University of California, Davis

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Prevention
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
Interventions Procedure: Incisional Negative Pressure Wound Therapy
Procedure: Standard Closure with Skin Glue
Device: PICO (Smith&Nephew)
Device: Dermabond
Enrollment 30
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Standard Closure Incisional Negative Pressure Wound Therapy
Hide Arm/Group Description

After surgical closure is complete, the patient receives standard of care operative incision treatment (dermabond/topical skin adhesive).

Standard Closure with Skin Glue

Dermabond: Final wound closure with skin glue.

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.

Incisional Negative Pressure Wound Therapy

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.

Period Title: Overall Study
Started 15 15
Completed 15 15
Not Completed 0 0
Arm/Group Title Standard Closure Incisional Negative Pressure Wound Therapy Total
Hide Arm/Group Description

After surgical closure is complete, the patient receives standard of care operative incision treatment (dermabond/topical skin adhesive).

Standard Closure with Skin Glue

Dermabond: Final wound closure with skin glue.

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.

Incisional Negative Pressure Wound Therapy

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.

Total of all reporting groups
Overall Number of Baseline Participants 15 15 30
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 15 participants 15 participants 30 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
15
 100.0%
13
  86.7%
28
  93.3%
>=65 years
0
   0.0%
2
  13.3%
2
   6.7%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 15 participants 15 participants 30 participants
54  (8.6) 57  (10) 55.6  (12.7)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 15 participants 15 participants 30 participants
Female
10
  66.7%
11
  73.3%
21
  70.0%
Male
5
  33.3%
4
  26.7%
9
  30.0%
Race and Ethnicity Not Collected   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 0 participants 0 participants 0 participants
0
[1]
Measure Analysis Population Description: Race and Ethnicity were not collected from any participant.
Region of Enrollment  
Measure Type: Count of Participants
Unit of measure:  Participants
United States Number Analyzed 15 participants 15 participants 30 participants
15
 100.0%
15
 100.0%
30
 100.0%
1.Primary Outcome
Title Major Wound Healing Complications
Hide Description Abscess, Hematoma or any wound complication requiring return to the operating room.
Time Frame Up to 3 months after operation
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Standard Closure Incisional Negative Pressure Wound Therapy
Hide Arm/Group Description:

After surgical closure is complete, the patient receives standard of care operative incision treatment (dermabond/topical skin adhesive).

Standard Closure with Skin Glue

Dermabond: Final wound closure with skin glue.

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.

Incisional Negative Pressure Wound Therapy

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.

Overall Number of Participants Analyzed 15 15
Measure Type: Count of Participants
Unit of Measure: Participants
5
  33.3%
3
  20.0%
2.Primary Outcome
Title Minor Wound Healing Complications
Hide Description Cellulitis, Seroma, Superficial Wound Separation
Time Frame Up to 3 months after operation
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Standard Closure Incisional Negative Pressure Wound Therapy
Hide Arm/Group Description:

After surgical closure is complete, the patient receives standard of care operative incision treatment (dermabond/topical skin adhesive).

Standard Closure with Skin Glue

Dermabond: Final wound closure with skin glue.

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.

Incisional Negative Pressure Wound Therapy

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.

Overall Number of Participants Analyzed 15 15
Measure Type: Count of Participants
Unit of Measure: Participants
3
  20.0%
2
  13.3%
3.Secondary Outcome
Title Time to Drain Removal
Hide Description Time to final drain removal after the operation
Time Frame Up to 3 months after operation
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Standard Closure Incisional Negative Pressure Wound Therapy
Hide Arm/Group Description:

After surgical closure is complete, the patient receives standard of care operative incision treatment (dermabond/topical skin adhesive).

Standard Closure with Skin Glue

Dermabond: Final wound closure with skin glue.

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.

Incisional Negative Pressure Wound Therapy

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.

Overall Number of Participants Analyzed 15 15
Mean (Standard Deviation)
Unit of Measure: days
29  (14.1) 24  (13.5)
4.Other Pre-specified Outcome
Title Scarring
Hide Description Will assess using Vancouver Scar Scale
Time Frame data not collected due to early termination
Outcome Measure Data Not Reported
5.Other Pre-specified Outcome
Title Pain Score Self Reported by the Patient After Surgery
Hide Description Assess via a visual analog scale at specified intervals
Time Frame data not collected due to early termination
Hide Outcome Measure Data
Hide Analysis Population Description
Unable to perform final analysis due to early closure of the study
Arm/Group Title Standard Closure Incisional Negative Pressure Wound Therapy
Hide Arm/Group Description:

After surgical closure is complete, the patient receives standard of care operative incision treatment (dermabond/topical skin adhesive).

Standard Closure with Skin Glue

Dermabond: Final wound closure with skin glue.

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.

Incisional Negative Pressure Wound Therapy

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.

Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
6.Other Pre-specified Outcome
Title Quality of Life as Measured by SF-36 Validated Survey
Hide Description Assess via SF-36 validated survey at specified intervals
Time Frame data not collected due to early termination
Hide Outcome Measure Data
Hide Analysis Population Description
unable to perform final analysis due to early termination of study
Arm/Group Title Standard Closure Incisional Negative Pressure Wound Therapy
Hide Arm/Group Description:

After surgical closure is complete, the patient receives standard of care operative incision treatment (dermabond/topical skin adhesive).

Standard Closure with Skin Glue

Dermabond: Final wound closure with skin glue.

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.

Incisional Negative Pressure Wound Therapy

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.

Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
Time Frame 6 months period following panniculectomy surgery
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Standard Closure Incisional Negative Pressure Wound Therapy
Hide Arm/Group Description

After surgical closure is complete, the patient receives standard of care operative incision treatment (dermabond/topical skin adhesive).

Standard Closure with Skin Glue

Dermabond: Final wound closure with skin glue.

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.

Incisional Negative Pressure Wound Therapy

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.

All-Cause Mortality
Standard Closure Incisional Negative Pressure Wound Therapy
Affected / at Risk (%) Affected / at Risk (%)
Total   0/15 (0.00%)   0/15 (0.00%) 
Hide Serious Adverse Events
Standard Closure Incisional Negative Pressure Wound Therapy
Affected / at Risk (%) Affected / at Risk (%)
Total   0/15 (0.00%)   0/15 (0.00%) 
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Standard Closure Incisional Negative Pressure Wound Therapy
Affected / at Risk (%) Affected / at Risk (%)
Total   0/15 (0.00%)   0/15 (0.00%) 
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Dr. Yunfeng Xue
Organization: UC Davis Medical Center
Phone: 408-603-0507
EMail: yunxue@ucdavis.edu
Layout table for additonal information
Responsible Party: University of California, Davis
ClinicalTrials.gov Identifier: NCT03010137    
Other Study ID Numbers: 801708
First Submitted: January 3, 2017
First Posted: January 4, 2017
Results First Submitted: March 26, 2020
Results First Posted: June 9, 2020
Last Update Posted: June 9, 2020