Trial Outcomes & Findings for Closed Incision Negative Pressure Wound Therapy vs. Foam as Post Operative Dressing (NCT NCT05427916)
NCT ID: NCT05427916
Last Updated: 2024-03-13
Results Overview
Healing complications are defined as the presence of at least one of the following conditions: infection (superficial or deep), dehiscence (partial, superficial, or deep), or delayed healing (incision not 100% closed within 7 days of the first surgical procedure)
TERMINATED
NA
20 participants
21 days
2024-03-13
Participant Flow
Recruitment began 6/1/22, with first enrollment on 7/12/22. Recruitment continued until study was terminated on 5/1/23.
Participant milestones
| Measure |
Negative Pressure Wound Therapy
Negative pressure to the incision site and managing exudate generated by the incision.
Avance Solo: Avance® Solo will include the collective description for a complete device capable of delivering negative pressure to the incision site and managing exudate generated by the incision.
|
Optifoam
This foam is standard of care and is currently stocked by the operating rooms at Mount Sinai hospital and indicated for use in high risk wounds
Optifoam: Optifoam is a silicone backed foam that is conformable, with a border that is waterproof, flexible and breathable for increased comfort, with a wear time of up to seven days. It is a standard of care product that is given to patients for surgical wounds.
|
|---|---|---|
|
Overall Study
STARTED
|
12
|
8
|
|
Overall Study
COMPLETED
|
0
|
0
|
|
Overall Study
NOT COMPLETED
|
12
|
8
|
Reasons for withdrawal
| Measure |
Negative Pressure Wound Therapy
Negative pressure to the incision site and managing exudate generated by the incision.
Avance Solo: Avance® Solo will include the collective description for a complete device capable of delivering negative pressure to the incision site and managing exudate generated by the incision.
|
Optifoam
This foam is standard of care and is currently stocked by the operating rooms at Mount Sinai hospital and indicated for use in high risk wounds
Optifoam: Optifoam is a silicone backed foam that is conformable, with a border that is waterproof, flexible and breathable for increased comfort, with a wear time of up to seven days. It is a standard of care product that is given to patients for surgical wounds.
|
|---|---|---|
|
Overall Study
Adverse Event
|
3
|
0
|
|
Overall Study
Lack of Efficacy
|
6
|
0
|
|
Overall Study
Active arm terminated; trial was ended.
|
3
|
8
|
Baseline Characteristics
Closed Incision Negative Pressure Wound Therapy vs. Foam as Post Operative Dressing
Baseline characteristics by cohort
| Measure |
Negative Pressure Wound Therapy
n=12 Participants
Negative pressure to the incision site and managing exudate generated by the incision.
Avance Solo: Avance® Solo will include the collective description for a complete device capable of delivering negative pressure to the incision site and managing exudate generated by the incision.
|
Optifoam
n=8 Participants
This foam is standard of care and is currently stocked by the operating rooms at Mount Sinai hospital and indicated for use in high risk wounds
Optifoam: Optifoam is a silicone backed foam that is conformable, with a border that is waterproof, flexible and breathable for increased comfort, with a wear time of up to seven days. It is a standard of care product that is given to patients for surgical wounds.
|
Total
n=20 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
58 years
n=5 Participants
|
71 years
n=7 Participants
|
64 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
8 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
12 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
4 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
4 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
8 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
13 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
6 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
2 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
4 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 21 daysPopulation: Data not collected. Study terminated before endpoint data collection.
Healing complications are defined as the presence of at least one of the following conditions: infection (superficial or deep), dehiscence (partial, superficial, or deep), or delayed healing (incision not 100% closed within 7 days of the first surgical procedure)
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 90 daysPopulation: Data not collected. Study terminated before endpoint data collection.
Incisional complication as assessed by number of skin necrosis complications
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 90 daysPopulation: Data not collected. Study terminated before endpoint data collection.
Incisional complication as assessed by number of cellulitis complications
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 90 daysPopulation: Data not collected. Study terminated before endpoint data collection.
Incisional complication as assessed by number of abscess complications
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 90 daysPopulation: Data not collected. Study terminated before endpoint data collection.
Incisional complication as assessed by number of suture abscess complications
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 90 daysPopulation: Data not collected. Study terminated before endpoint data collection.
Incisional complication as assessed by number of seroma complications
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 90 daysPopulation: Data not collected. Study terminated before endpoint data collection.
Incisional complication as assessed by number of periwound edema complications
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 90 daysPopulation: Data not collected. Study terminated before endpoint data collection.
Incisional complication as assessed by number of hematoma complications
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 90 daysPopulation: Data not collected. Study terminated before endpoint data collection.
Patient reported as none, mild, moderate, or severe
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 90 daysPopulation: Data not collected. Study terminated before endpoint data collection.
Patient Satisfaction Question that the patient will rank on a min/max scale of 0 to 7, higher score indicates higher satisfaction
Outcome measures
Outcome data not reported
Adverse Events
Negative Pressure Wound Therapy
Optifoam
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Negative Pressure Wound Therapy
n=12 participants at risk
Negative pressure to the incision site and managing exudate generated by the incision.
Avance Solo: Avance® Solo will include the collective description for a complete device capable of delivering negative pressure to the incision site and managing exudate generated by the incision.
|
Optifoam
n=8 participants at risk
This foam is standard of care and is currently stocked by the operating rooms at Mount Sinai hospital and indicated for use in high risk wounds
Optifoam: Optifoam is a silicone backed foam that is conformable, with a border that is waterproof, flexible and breathable for increased comfort, with a wear time of up to seven days. It is a standard of care product that is given to patients for surgical wounds.
|
|---|---|---|
|
Blood and lymphatic system disorders
Excessive serosanguinoius fluid secretion
|
8.3%
1/12 • Two weeks.
|
0.00%
0/8 • Two weeks.
|
|
Blood and lymphatic system disorders
Excessive bleeding
|
16.7%
2/12 • Two weeks.
|
0.00%
0/8 • Two weeks.
|
Additional Information
John C Lantis II
Icahn School of Medicine at Mount Sinai
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place