Trial Outcomes & Findings for Incisional Negative Pressure Wound Therapy in High Risk Patients Undergoing Panniculectomy: A Prospective Randomized Controlled Trial (NCT NCT03010137)

Results Overview

Abscess, Hematoma or any wound complication requiring return to the operating room.

Recruitment status

TERMINATED

Study phase

NA

Target enrollment

30 participants

Primary outcome timeframe

Up to 3 months after operation

Results posted on

2020-06-09

Participant Flow

Participant milestones

Participant milestones
Measure	Standard Closure 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.	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. 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 Study STARTED	15	15
Overall Study COMPLETED	15	15
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Standard Closure n=15 Participants 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.	Incisional Negative Pressure Wound Therapy n=15 Participants 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 n=30 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=15 Participants	0 Participants n=15 Participants	0 Participants n=30 Participants
Age, Categorical Between 18 and 65 years	15 Participants n=15 Participants	13 Participants n=15 Participants	28 Participants n=30 Participants
Age, Categorical >=65 years	0 Participants n=15 Participants	2 Participants n=15 Participants	2 Participants n=30 Participants
Age, Continuous	54 years STANDARD_DEVIATION 8.6 • n=15 Participants	57 years STANDARD_DEVIATION 10 • n=15 Participants	55.6 years STANDARD_DEVIATION 12.7 • n=30 Participants
Sex: Female, Male Female	10 Participants n=15 Participants	11 Participants n=15 Participants	21 Participants n=30 Participants
Sex: Female, Male Male	5 Participants n=15 Participants	4 Participants n=15 Participants	9 Participants n=30 Participants
Race and Ethnicity Not Collected	—	—	0 Participants Race and Ethnicity were not collected from any participant.
Region of Enrollment United States	15 Participants n=15 Participants	15 Participants n=15 Participants	30 Participants n=30 Participants

PRIMARY outcome

Timeframe: Up to 3 months after operation

Abscess, Hematoma or any wound complication requiring return to the operating room.

Outcome measures

Outcome measures
Measure	Standard Closure n=15 Participants 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.	Incisional Negative Pressure Wound Therapy n=15 Participants 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.
Major Wound Healing Complications	5 Participants	3 Participants

PRIMARY outcome

Timeframe: Up to 3 months after operation

Cellulitis, Seroma, Superficial Wound Separation

Outcome measures

Outcome measures
Measure	Standard Closure n=15 Participants 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.	Incisional Negative Pressure Wound Therapy n=15 Participants 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.
Minor Wound Healing Complications	3 Participants	2 Participants

SECONDARY outcome

Timeframe: Up to 3 months after operation

Time to final drain removal after the operation

Outcome measures

Outcome measures
Measure	Standard Closure n=15 Participants 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.	Incisional Negative Pressure Wound Therapy n=15 Participants 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.
Time to Drain Removal	29 days Standard Deviation 14.1	24 days Standard Deviation 13.5

OTHER_PRE_SPECIFIED outcome

Timeframe: data not collected due to early termination

Will assess using Vancouver Scar Scale

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: data not collected due to early termination

Population: Unable to perform final analysis due to early closure of the study

Assess via a visual analog scale at specified intervals

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: data not collected due to early termination

Population: unable to perform final analysis due to early termination of study

Assess via SF-36 validated survey at specified intervals

Outcome measures

Outcome data not reported

Adverse Events

Standard Closure

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Incisional Negative Pressure Wound Therapy

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. Yunfeng Xue

UC Davis Medical Center

Phone: 408-603-0507

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place