Hypertrophic Skin Condition of Anterior Abdomen
Conditions
Brief summary
There are millions of births each year with 32% of women undergoing cesarean sections (C-sections), which results in skin scarring. Repeat C-sections increased by 178% from 1979-2010. Given the frequency of C-sections, it is important to achieve a desirable cosmetic outcome. 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. This study aims to compare the aesthetic appearance by using The Patient and Observer Scar Assessment Scale (POSAS) scar assessment scale following closed incision negative pressure therapy with a PICO 7 dressing to the standard abdominal dressing in women undergoing repeat cesarean sections
Detailed description
Single, randomized controlled trial in women undergoing a repeat cesarean delivery. Women will be randomized to placement of a PICO 7 dressing or a standard abdominal dressing at the time of cesarean. The standard abdominal dressing will be removed approximately on postoperative day (POD) 1-2 and the PICO 7 dressing will be removed approximately on POD 3-4 (prior to discharge). If the patient with a PICO dressing remains inpatient for longer than 7 postoperative days, the PICO dressing will be removed prior to POD 7, in accordance with device instructions. Participants in both groups will be sent POSAS surveys at the two, four and six week visit window with primary outcome being aesthetic appearance (cosmesis) at six weeks. Observers (healthcare providers) will complete a POSAS survey at the postpartum visit (\ 4-6 weeks postoperative) to rate scar quality.
Interventions
DEVICEPICO 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.
Standard abdominal dressing at the time of cesarean
Sponsors
Indiana University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Intervention model description
Women will be randomized to placement of a PICO 7 dressing or a standard abdominal dressing at the time of cesarean. The standard abdominal dressing will be removed approximately on postoperative day (POD) 1-2 and the PICO 7 dressing will be removed approximately on POD 3-4 (prior to discharge). If the patient with a PICO dressing remains inpatient for longer than 7 postoperative days, the PICO dressing will be removed prior to POD 7, in accordance with device instructions. Participants in both groups will be sent POSAS surveys at the two, four and six week visit window with primary outcome being aesthetic appearance (cosmesis) at six weeks. Observers (healthcare providers) will complete a POSAS survey at the postpartum visit (\ 4-6 weeks postoperative) to rate scar quality.
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* Scheduled or non-labor repeat cesarean delivery * One or more prior cesarean section(s) with prior pfannenstiel incision scar * Gestational age \> 23 weeks * Age 18 and older
Exclusion criteria
* Patients with malignancy in the wound bed or margins of the wound * Non-enteric and unexplored fistulas * Necrotic tissue with eschar present * Exposed arteries, veins, nerves or organs * Exposed anastomotic sites * Cellulitis or evidence of active infection * Known allergy to adhesive tape * Patient unwilling to follow-up * Contraindication to NPWT * Bleeding disorder * Therapeutic anticoagulation * Allergy to any component of the dressing (perhaps list these as you will need to know to confirm eligibility of each patient) * Prior irradiated skin
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Subjective Cosmetic Result | 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. |
| Patient Satisfaction With Wound Appearance | Week 6 | Scale of 1 - 10 with 1 being least satisfied and 10 being most satisfied |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Analog Pain Scores 72 Hours | 72 hours after surgery | 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. |
| Analog Pain Scores @4 Weeks | 4 weeks after surgery at postpartum visit | 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. |
| Procedure Time in Minutes | Start of surgery until application of wound vac immediately post-procedure | Procedure time in minutes |
| Incision Healing Complications up to 42 Days Postoperatively | 42 day after surgery | Number of Participants with Incision Healing Complications up to 42 Days Postoperatively |
| Analog Pain Scores @6 Weeks | 6 weeks after surgery at postpartum visit | 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. |
| Analog Pain Scores 48 Hours | 48 hours after surgery | 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. |
Countries
United States
Participant flow
Recruitment details
Patients recruited from medical clinic and in-patient admissions.
Pre-assignment details
There are no pre-assignment factors that impact participant enrollment.
Participants by arm
| Arm | Count |
|---|---|
| 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. | 12 |
| 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 | 12 |
| Total | 24 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Withdrawal by Subject | 8 | 4 |
Baseline characteristics
| Characteristic | Treatment Group | Control Group | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 12 Participants | 12 Participants | 24 Participants |
| Race and Ethnicity Not Collected | — | — | 0 Participants |
| Region of Enrollment United States | 12 participants | 12 participants | 24 participants |
| Scar Assessment | 19 units on a scale | 33 units on a scale | 26 units on a scale |
| Sex/Gender, Customized Sex Female | 12 Participants | 12 Participants | 24 Participants |
| Sex/Gender, Customized Sex Male | 0 Participants | 0 Participants | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 12 | 0 / 12 |
| other Total, other adverse events | 0 / 12 | 0 / 12 |
| serious Total, serious adverse events | 0 / 12 | 0 / 12 |
Outcome results
Primary
Patient Satisfaction With Wound Appearance
Scale of 1 - 10 with 1 being least satisfied and 10 being most satisfied
Time frame: 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.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Treatment Group | Patient Satisfaction With Wound Appearance | 2 score on a scale |
| Control Group | Patient Satisfaction With Wound Appearance | 7 score on a scale |
Primary
Subjective Cosmetic Result
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.
Time frame: Week 6
Population: The only subjects analyzed were those that were evaluated in week 6
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Treatment Group | Subjective Cosmetic Result | 13 units on a scale |
| Control Group | Subjective Cosmetic Result | 26.5 units on a scale |
Secondary
Analog Pain Scores 48 Hours
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.
Time frame: 48 hours after surgery
Population: No data was collected
Secondary
Analog Pain Scores @4 Weeks
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.
Time frame: 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.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Treatment Group | Analog Pain Scores @4 Weeks | 2 score on a scale |
| Control Group | Analog Pain Scores @4 Weeks | 6 score on a scale |
Secondary
Analog Pain Scores @6 Weeks
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.
Time frame: 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
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Treatment Group | Analog Pain Scores @6 Weeks | 1.5 score on a scale |
| Control Group | Analog Pain Scores @6 Weeks | 1.5 score on a scale |
Secondary
Analog Pain Scores 72 Hours
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.
Time frame: 72 hours after surgery
Population: No Data was collected
Secondary
Incision Healing Complications up to 42 Days Postoperatively
Number of Participants with Incision Healing Complications up to 42 Days Postoperatively
Time frame: 42 day after surgery
Population: Some participants did not complete follow up as scheduled. Data analysed reflects participants with collected data.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Treatment Group | Incision Healing Complications up to 42 Days Postoperatively | 0 Participants |
| Control Group | Incision Healing Complications up to 42 Days Postoperatively | 0 Participants |
Secondary
Procedure Time in Minutes
Procedure time in minutes
Time frame: Start of surgery until application of wound vac immediately post-procedure
Population: Data was not collected.