Trial Outcomes & Findings for Negative Pressure Wound Therapy-PICO: Cosmesis in Repeat C-Sections (NCT NCT05266053)

Results Overview

Patients were evaluated using the Patient and Observer Scar Assessment (POSAS) Scale. Patient is asked as series of subjective questions regarding (vascularity, pigmentation, thickness, relief, pliability, surface area). Participants respond with a scale of 1 - 10 with 10 as the most severe appearance and 1 as the least severe appearance. These scores are summed for a total value of 6 (total best outcome) through 60 (total worst outcome). The full range provided reflects the actual collected data from the participants.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

24 participants

Primary outcome timeframe

Week 6

Results posted on

2024-09-03

Participant Flow

Patients recruited from medical clinic and in-patient admissions.

There are no pre-assignment factors that impact participant enrollment.

Participant milestones

Participant milestones
Measure	Treatment Group This group will have a PICO negative pressure wound treatment device applied to their surgical wound site. PICO 7 dressing: The PICO 7 dressing consists of a negative pressure wound therapy pump (NPWT) connected to an absorbent gentle adhesive dressing that is applied to a wound. When the pump is activated, it acts by pulling excess fluid from the wound. The dressing absorbs this fluid and helps to prevent bacteria from entering the wound. It has been shown to prevent wound infections and promote healing.	Control Group Standard Intervention. This group will have a standard wound dressing (gauze, bandage) applied to their surgical wound site. Standard wound dressing: Standard abdominal dressing at the time of cesarean
Overall Study STARTED	12	12
Overall Study COMPLETED	4	8
Overall Study NOT COMPLETED	8	4

Reasons for withdrawal

Reasons for withdrawal
Measure	Treatment Group This group will have a PICO negative pressure wound treatment device applied to their surgical wound site. PICO 7 dressing: The PICO 7 dressing consists of a negative pressure wound therapy pump (NPWT) connected to an absorbent gentle adhesive dressing that is applied to a wound. When the pump is activated, it acts by pulling excess fluid from the wound. The dressing absorbs this fluid and helps to prevent bacteria from entering the wound. It has been shown to prevent wound infections and promote healing.	Control Group Standard Intervention. This group will have a standard wound dressing (gauze, bandage) applied to their surgical wound site. Standard wound dressing: Standard abdominal dressing at the time of cesarean
Overall Study Withdrawal by Subject	8	4

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Treatment Group n=12 Participants This group will have a PICO negative pressure wound treatment device applied to their surgical wound site. PICO 7 dressing: The PICO 7 dressing consists of a negative pressure wound therapy pump (NPWT) connected to an absorbent gentle adhesive dressing that is applied to a wound. When the pump is activated, it acts by pulling excess fluid from the wound. The dressing absorbs this fluid and helps to prevent bacteria from entering the wound. It has been shown to prevent wound infections and promote healing.	Control Group n=12 Participants Standard Intervention. This group will have a standard wound dressing (gauze, bandage) applied to their surgical wound site. Standard wound dressing: Standard abdominal dressing at the time of cesarean	Total n=24 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=12 Participants	0 Participants n=12 Participants	0 Participants n=24 Participants
Age, Categorical Between 18 and 65 years	12 Participants n=12 Participants	12 Participants n=12 Participants	24 Participants n=24 Participants
Age, Categorical >=65 years	0 Participants n=12 Participants	0 Participants n=12 Participants	0 Participants n=24 Participants
Sex/Gender, Customized Sex · Female	12 Participants n=12 Participants	12 Participants n=12 Participants	24 Participants n=24 Participants
Sex/Gender, Customized Sex · Male	0 Participants n=12 Participants	0 Participants n=12 Participants	0 Participants n=24 Participants
Race and Ethnicity Not Collected	—	—	0 Participants Race and Ethnicity were not collected from any participant.
Region of Enrollment United States	12 participants n=12 Participants	12 participants n=12 Participants	24 participants n=24 Participants
Scar Assessment	19 units on a scale n=5 Participants • Subjects analyzed were much lower due to lack of patient response and patients loss to follow up.	33 units on a scale n=2 Participants • Subjects analyzed were much lower due to lack of patient response and patients loss to follow up.	26 units on a scale n=7 Participants • Subjects analyzed were much lower due to lack of patient response and patients loss to follow up.

PRIMARY outcome

Timeframe: Week 6

Population: The only subjects analyzed were those that were evaluated in week 6

Patients were evaluated using the Patient and Observer Scar Assessment (POSAS) Scale. Patient is asked as series of subjective questions regarding (vascularity, pigmentation, thickness, relief, pliability, surface area). Participants respond with a scale of 1 - 10 with 10 as the most severe appearance and 1 as the least severe appearance. These scores are summed for a total value of 6 (total best outcome) through 60 (total worst outcome). The full range provided reflects the actual collected data from the participants.

Outcome measures

Outcome measures
Measure	Treatment Group n=8 Participants This group will have a PICO negative pressure wound treatment device applied to their surgical wound site. PICO 7 dressing: The PICO 7 dressing consists of a negative pressure wound therapy pump (NPWT) connected to an absorbent gentle adhesive dressing that is applied to a wound. When the pump is activated, it acts by pulling excess fluid from the wound. The dressing absorbs this fluid and helps to prevent bacteria from entering the wound. It has been shown to prevent wound infections and promote healing.	Control Group n=4 Participants Standard Intervention. This group will have a standard wound dressing (gauze, bandage) applied to their surgical wound site. Standard wound dressing: Standard abdominal dressing at the time of cesarean
Subjective Cosmetic Result	13 units on a scale Interval 10.0 to 16.5	26.5 units on a scale Interval 16.0 to 36.5

PRIMARY outcome

Timeframe: Week 6

Population: Some participants did not complete surveys so the Overall Number of Participants reflects participants with scale data collected. The full range provided reflects the actual collected data from the participants.

Scale of 1 - 10 with 1 being least satisfied and 10 being most satisfied

Outcome measures

Outcome measures
Measure	Treatment Group n=1 Participants This group will have a PICO negative pressure wound treatment device applied to their surgical wound site. PICO 7 dressing: The PICO 7 dressing consists of a negative pressure wound therapy pump (NPWT) connected to an absorbent gentle adhesive dressing that is applied to a wound. When the pump is activated, it acts by pulling excess fluid from the wound. The dressing absorbs this fluid and helps to prevent bacteria from entering the wound. It has been shown to prevent wound infections and promote healing.	Control Group n=2 Participants Standard Intervention. This group will have a standard wound dressing (gauze, bandage) applied to their surgical wound site. Standard wound dressing: Standard abdominal dressing at the time of cesarean
Patient Satisfaction With Wound Appearance	2 score on a scale Interval 2.0 to 2.0	7 score on a scale Interval 4.0 to 10.0

SECONDARY outcome

Timeframe: Start of surgery until application of wound vac immediately post-procedure

Population: Data was not collected.

Procedure time in minutes

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 48 hours after surgery

Population: No data was collected

Participants respond with a scale of 1 - 10 with 10 as most severe and 1 as not at all. The full range provided reflects the actual collected data from the participants.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 72 hours after surgery

Population: No Data was collected

Participants respond with a scale of 1 - 10 with 10 as the most severe and 1 being no pain at all. The full range provided reflects the actual collected data from the participants.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 4 weeks after surgery at postpartum visit

Population: Some participants did not complete surveys so the Overall Number of Participants reflects participants with scale data collected.

Participants respond with a scale of 1 - 10 with 10 as the most severe and 1 being no pain at all. The full range provided reflects the actual collected data from the participants.

Outcome measures

Outcome measures
Measure	Treatment Group n=5 Participants This group will have a PICO negative pressure wound treatment device applied to their surgical wound site. PICO 7 dressing: The PICO 7 dressing consists of a negative pressure wound therapy pump (NPWT) connected to an absorbent gentle adhesive dressing that is applied to a wound. When the pump is activated, it acts by pulling excess fluid from the wound. The dressing absorbs this fluid and helps to prevent bacteria from entering the wound. It has been shown to prevent wound infections and promote healing.	Control Group n=2 Participants Standard Intervention. This group will have a standard wound dressing (gauze, bandage) applied to their surgical wound site. Standard wound dressing: Standard abdominal dressing at the time of cesarean
Analog Pain Scores @4 Weeks	2 score on a scale Interval 1.0 to 5.0	6 score on a scale Interval 2.0 to 10.0

SECONDARY outcome

Timeframe: 6 weeks after surgery at postpartum visit

Population: Some participants did not complete surveys so the Overall Number of Participants reflects participants with scale data collected

Participants respond with a scale of 1 - 10 with 10 as the most severe and 1 being no pain at all. The full range provided reflects the actual collected data from the participants.

Outcome measures

Outcome measures
Measure	Treatment Group n=8 Participants This group will have a PICO negative pressure wound treatment device applied to their surgical wound site. PICO 7 dressing: The PICO 7 dressing consists of a negative pressure wound therapy pump (NPWT) connected to an absorbent gentle adhesive dressing that is applied to a wound. When the pump is activated, it acts by pulling excess fluid from the wound. The dressing absorbs this fluid and helps to prevent bacteria from entering the wound. It has been shown to prevent wound infections and promote healing.	Control Group n=4 Participants Standard Intervention. This group will have a standard wound dressing (gauze, bandage) applied to their surgical wound site. Standard wound dressing: Standard abdominal dressing at the time of cesarean
Analog Pain Scores @6 Weeks	1.5 score on a scale Interval 1.0 to 3.0	1.5 score on a scale Interval 1.0 to 4.0

SECONDARY outcome

Timeframe: 42 day after surgery

Population: Some participants did not complete follow up as scheduled. Data analysed reflects participants with collected data.

Number of Participants with Incision Healing Complications up to 42 Days Postoperatively

Outcome measures

Outcome measures
Measure	Treatment Group n=8 Participants This group will have a PICO negative pressure wound treatment device applied to their surgical wound site. PICO 7 dressing: The PICO 7 dressing consists of a negative pressure wound therapy pump (NPWT) connected to an absorbent gentle adhesive dressing that is applied to a wound. When the pump is activated, it acts by pulling excess fluid from the wound. The dressing absorbs this fluid and helps to prevent bacteria from entering the wound. It has been shown to prevent wound infections and promote healing.	Control Group n=4 Participants Standard Intervention. This group will have a standard wound dressing (gauze, bandage) applied to their surgical wound site. Standard wound dressing: Standard abdominal dressing at the time of cesarean
Incision Healing Complications up to 42 Days Postoperatively	0 Participants	0 Participants

Adverse Events

Treatment Group

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Control Group

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. Lisa Mims - Principal Investigator

Indiana University

Phone: 7733074863

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place