Trial Outcomes & Findings for PICO Breast Reduction Clinical Study Looking at Incision Healing Complications (NCT NCT01640366)
NCT ID: NCT01640366
Last Updated: 2020-02-28
Results Overview
The primary variable of whether or not the incision developed a healing complication within 21 days of surgery was defined as the presence of at least one of the following: 1. Infection (superficial or deep), 2. Dehiscence (partial, superficial or deep), 3. Delayed healing (defined as incision not closed within 7 days of the first surgical procedure). All participants received both PICO and standard care dressings simultaneously during the course of the study; randomized to either right breast for PICO and left breast for standard of care OR right breast standard of care and left breast PICO.
COMPLETED
NA
200 participants
21 days postoperatively
2020-02-28
Participant Flow
There were 200 participants enrolled in this study.
Participant milestones
| Measure |
PICO Negative Pressure Wound Therapy/Standard of Care Dressing
PICO (single-use Negative Pressure Wound Therapy system \[su-NPWT\]) or standard of care dressing (sterile gauze adhesive strips) were randomized to either breast following bilateral breast reduction surgery for concomitant treatment to assess the aesthetic appearance and quality of resultant scar.
|
|---|---|
|
Overall Study
STARTED
|
200
|
|
Overall Study
Day 21 Follow-up
|
185
|
|
Overall Study
Day 42 Follow-up
|
177
|
|
Overall Study
Day 90 Follow-up
|
178
|
|
Overall Study
COMPLETED
|
178
|
|
Overall Study
NOT COMPLETED
|
22
|
Reasons for withdrawal
| Measure |
PICO Negative Pressure Wound Therapy/Standard of Care Dressing
PICO (single-use Negative Pressure Wound Therapy system \[su-NPWT\]) or standard of care dressing (sterile gauze adhesive strips) were randomized to either breast following bilateral breast reduction surgery for concomitant treatment to assess the aesthetic appearance and quality of resultant scar.
|
|---|---|
|
Overall Study
Withdrawal by Subject
|
1
|
|
Overall Study
Protocol Violation
|
16
|
|
Overall Study
Lost to Follow-up
|
5
|
Baseline Characteristics
PICO Breast Reduction Clinical Study Looking at Incision Healing Complications
Baseline characteristics by cohort
| Measure |
PICO Negative Pressure Wound Therapy/Standard of Care Dressing
n=199 Participants
PICO (single-use Negative Pressure Wound Therapy system \[su-NPWT\]) or standard of care dressing (sterile gauze adhesive strips) were randomized to either breast following bilateral breast reduction surgery for concomitant treatment to assess the aesthetic appearance and quality of resultant scar.
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
199 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
199 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Caucasian
|
66 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
African American
|
50 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Hispanic
|
22 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Other
|
55 Participants
n=5 Participants
|
|
Region of Enrollment
Netherlands
|
33 participants
n=5 Participants
|
|
Region of Enrollment
United States
|
91 participants
n=5 Participants
|
|
Region of Enrollment
France
|
8 participants
n=5 Participants
|
|
Region of Enrollment
South Africa
|
68 participants
n=5 Participants
|
|
BMI
|
30.0 kg/m^2
n=5 Participants
|
|
Administration of Prophylactic Antibiotics
Yes
|
188 Participants
n=5 Participants
|
|
Administration of Prophylactic Antibiotics
No
|
11 Participants
n=5 Participants
|
|
Surgical Technique
Superior pedicle
|
18 Participants
n=5 Participants
|
|
Surgical Technique
Inferior pedicle (with inverted "T" incision)
|
55 Participants
n=5 Participants
|
|
Surgical Technique
Superior and inferior pedicle
|
6 Participants
n=5 Participants
|
|
Surgical Technique
Superior pedicle and superomedial
|
2 Participants
n=5 Participants
|
|
Surgical Technique
Other
|
118 Participants
n=5 Participants
|
|
Duration of Surgery
|
168.3 minutes
n=5 Participants
|
|
Mean Tissue Resection Weight
< 500 g
|
68 Participants
n=5 Participants
|
|
Mean Tissue Resection Weight
500 - <1000 g
|
82 Participants
n=5 Participants
|
|
Mean Tissue Resection Weight
1000 - <1500 g
|
31 Participants
n=5 Participants
|
|
Mean Tissue Resection Weight
> 1500 g
|
18 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 21 days postoperativelyPopulation: There were 200 participants enrolled with 1 participant lost to follow-up immediately after surgery.
The primary variable of whether or not the incision developed a healing complication within 21 days of surgery was defined as the presence of at least one of the following: 1. Infection (superficial or deep), 2. Dehiscence (partial, superficial or deep), 3. Delayed healing (defined as incision not closed within 7 days of the first surgical procedure). All participants received both PICO and standard care dressings simultaneously during the course of the study; randomized to either right breast for PICO and left breast for standard of care OR right breast standard of care and left breast PICO.
Outcome measures
| Measure |
PICO Negative Pressure Wound Therapy/Standard of Care Dressing
n=199 Participants
PICO (single-use Negative Pressure Wound Therapy system \[su-NPWT\]) or standard of care dressing (sterile gauze adhesive strips) were randomized to either breast following bilateral breast reduction surgery for concomitant treatment to assess the aesthetic appearance and quality of resultant scar.
|
|---|---|
|
Number of Participants Experiencing Incision Healing Complications up to Day 21 Postoperatively
PICO treatment with healing complications
|
113 participants
|
|
Number of Participants Experiencing Incision Healing Complications up to Day 21 Postoperatively
PICO treatment without healing complications
|
86 participants
|
|
Number of Participants Experiencing Incision Healing Complications up to Day 21 Postoperatively
Standard care with healing complications
|
123 participants
|
|
Number of Participants Experiencing Incision Healing Complications up to Day 21 Postoperatively
Standard care without healing complications
|
76 participants
|
SECONDARY outcome
Timeframe: 21 days postoperativelyPopulation: There were 200 participants enrolled with 1 participant lost to follow-up immediately after surgery. All available results at this time point.
Assessment of the number of participants' incisions that experienced dehiscence (superficial, partial, or deep) occurring up to and 21 days postoperatively between incisions treated with PICO compared with standard care dressings. All participants received both PICO and standard care dressings simultaneously during the course of the study; randomized to either right breast for PICO and left breast for standard of care OR right breast standard of care and left breast PICO.
Outcome measures
| Measure |
PICO Negative Pressure Wound Therapy/Standard of Care Dressing
n=199 Participants
PICO (single-use Negative Pressure Wound Therapy system \[su-NPWT\]) or standard of care dressing (sterile gauze adhesive strips) were randomized to either breast following bilateral breast reduction surgery for concomitant treatment to assess the aesthetic appearance and quality of resultant scar.
|
|---|---|
|
Number of Participants Experiencing Postsurgical Incision Healing Complications (Dehiscence) Occurring up to Day 21 Postoperatively
PICO treatment with wound dehiscence
|
32 participants
|
|
Number of Participants Experiencing Postsurgical Incision Healing Complications (Dehiscence) Occurring up to Day 21 Postoperatively
PICO treatment without wound dehiscence
|
165 participants
|
|
Number of Participants Experiencing Postsurgical Incision Healing Complications (Dehiscence) Occurring up to Day 21 Postoperatively
Standard care with wound dehiscence
|
52 participants
|
|
Number of Participants Experiencing Postsurgical Incision Healing Complications (Dehiscence) Occurring up to Day 21 Postoperatively
Standard care without wound dehiscence
|
145 participants
|
SECONDARY outcome
Timeframe: 21 days postoperativelyPopulation: There were 200 participants enrolled with 1 participant lost to follow-up immediately after surgery. All available results at this time point.
Assessment of the number of participants' incisions that experienced an infection (superficial or deep) occurring up to and 21 days postoperatively between incisions treated with PICO compared with standard care dressings. All participants received both PICO and standard care dressings simultaneously during the course of the study; randomized to either right breast for PICO and left breast for standard of care OR right breast standard of care and left breast PICO.
Outcome measures
| Measure |
PICO Negative Pressure Wound Therapy/Standard of Care Dressing
n=199 Participants
PICO (single-use Negative Pressure Wound Therapy system \[su-NPWT\]) or standard of care dressing (sterile gauze adhesive strips) were randomized to either breast following bilateral breast reduction surgery for concomitant treatment to assess the aesthetic appearance and quality of resultant scar.
|
|---|---|
|
Number of Participants Experiencing Postsurgical Incision Healing Complications (Infection) Occurring up to Day 21 Postoperatively
PICO treatment with wound infection
|
4 participants
|
|
Number of Participants Experiencing Postsurgical Incision Healing Complications (Infection) Occurring up to Day 21 Postoperatively
PICO treatment without wound infection
|
193 participants
|
|
Number of Participants Experiencing Postsurgical Incision Healing Complications (Infection) Occurring up to Day 21 Postoperatively
Standard care with wound infection
|
6 participants
|
|
Number of Participants Experiencing Postsurgical Incision Healing Complications (Infection) Occurring up to Day 21 Postoperatively
Standard care without wound infection
|
191 participants
|
SECONDARY outcome
Timeframe: Within 7 days postoperativelyPopulation: There were 200 participants enrolled with 1 participant lost to follow-up immediately after surgery.
Assessment of the number of participants' incisions that experienced delayed healing within 7 days of surgery between incisions treated with PICO compared with standard care dressings. All participants received both PICO and standard care dressings simultaneously during the course of the study; randomized to either right breast for PICO and left breast for standard of care OR right breast standard of care and left breast PICO.
Outcome measures
| Measure |
PICO Negative Pressure Wound Therapy/Standard of Care Dressing
n=199 Participants
PICO (single-use Negative Pressure Wound Therapy system \[su-NPWT\]) or standard of care dressing (sterile gauze adhesive strips) were randomized to either breast following bilateral breast reduction surgery for concomitant treatment to assess the aesthetic appearance and quality of resultant scar.
|
|---|---|
|
Number of Participants Experiencing Postsurgical Incision Healing Complications (Delayed Healing) Occurring Within 7 Days Postoperatively
PICO treatment with delayed healing
|
102 participants
|
|
Number of Participants Experiencing Postsurgical Incision Healing Complications (Delayed Healing) Occurring Within 7 Days Postoperatively
PICO treatment without delayed healing
|
97 participants
|
|
Number of Participants Experiencing Postsurgical Incision Healing Complications (Delayed Healing) Occurring Within 7 Days Postoperatively
Standard care with delayed healing
|
103 participants
|
|
Number of Participants Experiencing Postsurgical Incision Healing Complications (Delayed Healing) Occurring Within 7 Days Postoperatively
Standard care without delayed healing
|
96 participants
|
SECONDARY outcome
Timeframe: Within 10 days postoperativelyPopulation: There were 200 participants enrolled with 1 participant lost to follow-up immediately after surgery.
Assessment of the number of participants' incisions that experienced delayed healing within 10 days of surgery between incisions treated with PICO compared with standard care dressings. All participants received both PICO and standard care dressings simultaneously during the course of the study; randomized to either right breast for PICO and left breast for standard of care OR right breast standard of care and left breast PICO.
Outcome measures
| Measure |
PICO Negative Pressure Wound Therapy/Standard of Care Dressing
n=199 Participants
PICO (single-use Negative Pressure Wound Therapy system \[su-NPWT\]) or standard of care dressing (sterile gauze adhesive strips) were randomized to either breast following bilateral breast reduction surgery for concomitant treatment to assess the aesthetic appearance and quality of resultant scar.
|
|---|---|
|
Number of Participants Experiencing Postsurgical Incision Healing Complications (Delayed Healing) Occurring Within 10 Days Postoperatively
PICO treatment with delayed healing
|
64 participants
|
|
Number of Participants Experiencing Postsurgical Incision Healing Complications (Delayed Healing) Occurring Within 10 Days Postoperatively
PICO treatment without delayed healing
|
135 participants
|
|
Number of Participants Experiencing Postsurgical Incision Healing Complications (Delayed Healing) Occurring Within 10 Days Postoperatively
Standard care with delayed healing
|
64 participants
|
|
Number of Participants Experiencing Postsurgical Incision Healing Complications (Delayed Healing) Occurring Within 10 Days Postoperatively
Standard care without delayed healing
|
135 participants
|
SECONDARY outcome
Timeframe: 90 days postoperativelyPopulation: There were 200 participants enrolled with 1 participant lost to follow-up immediately after surgery. All available results at the 90 day time point.
Assessment of the Patient and Observer Scar Assessment Scale (POSAS) and the Visual Analogue Scale (VAS) between postsurgical incisions treated with PICO compared with standard care dressings. VAS score: Assessed for color, appearance, contour, distortion, and texture. Each score ranged from 5 to 18; 5 being 'excellent' and 18 being 'poor.' Also, a global scar score was included in the total score. POSAS score: Scored in 2 parts which added to create a total score, observer score and patient score. The lowest score of 1 showed 'normal' skin and the highest score of 10 showed the 'worst imaginable' result. Observer score = 6 categories (vascularity, pigmentation, thickness, relief, pliability, and surface area) each given a score of 1-10. Patient score = 6 categories (scar pain, itching, color, stiffness, thickness, and irregularity each given a score of 1-10. All participants received both PICO and standard care dressings simultaneously during the course of the study.
Outcome measures
| Measure |
PICO Negative Pressure Wound Therapy/Standard of Care Dressing
n=199 Participants
PICO (single-use Negative Pressure Wound Therapy system \[su-NPWT\]) or standard of care dressing (sterile gauze adhesive strips) were randomized to either breast following bilateral breast reduction surgery for concomitant treatment to assess the aesthetic appearance and quality of resultant scar.
|
|---|---|
|
Aesthetic Appearance (Cosmesis) and Scar Quality at 90 Days Postoperatively
PICO - VAS Global Assessment
|
3 score on a scale
Interval 1.0 to 9.0
|
|
Aesthetic Appearance (Cosmesis) and Scar Quality at 90 Days Postoperatively
Standard care - VAS Global Assessment
|
3 score on a scale
Interval 1.0 to 8.0
|
|
Aesthetic Appearance (Cosmesis) and Scar Quality at 90 Days Postoperatively
PICO - POSAS Observer Total
|
16 score on a scale
Interval 7.0 to 41.0
|
|
Aesthetic Appearance (Cosmesis) and Scar Quality at 90 Days Postoperatively
Standard care - POSAS Observer Total
|
18 score on a scale
Interval 9.0 to 44.0
|
|
Aesthetic Appearance (Cosmesis) and Scar Quality at 90 Days Postoperatively
PICO - POSAS Patient Total
|
15 score on a scale
Interval 6.0 to 51.0
|
|
Aesthetic Appearance (Cosmesis) and Scar Quality at 90 Days Postoperatively
Standard care - POSAS Patient Total
|
19 score on a scale
Interval 6.0 to 50.0
|
SECONDARY outcome
Timeframe: 21 days postoperativelyPopulation: There were 200 participants enrolled with 1 participant lost to follow-up immediately after surgery. All available results for this time point.
The nipple and areola areas were not covered by the PICO or standard care dressing as part of the evaluation, they were all dressed the same with Steri-strips and dry gauze pads, which was essentially the standard care dressing regime. All participants received both PICO and standard care dressings simultaneously during the course of the study; randomized to either right breast for PICO and left breast for standard of care OR right breast standard of care and left breast PICO.
Outcome measures
| Measure |
PICO Negative Pressure Wound Therapy/Standard of Care Dressing
n=199 Participants
PICO (single-use Negative Pressure Wound Therapy system \[su-NPWT\]) or standard of care dressing (sterile gauze adhesive strips) were randomized to either breast following bilateral breast reduction surgery for concomitant treatment to assess the aesthetic appearance and quality of resultant scar.
|
|---|---|
|
Number of Skin, Nipple and Areola Necrosis Occurring up to and 21 Days Postoperatively
PICO - skin necrosis
|
2 Participants
|
|
Number of Skin, Nipple and Areola Necrosis Occurring up to and 21 Days Postoperatively
Standard care - skin necrosis
|
7 Participants
|
|
Number of Skin, Nipple and Areola Necrosis Occurring up to and 21 Days Postoperatively
PICO - nipple and areola necrosis
|
2 Participants
|
|
Number of Skin, Nipple and Areola Necrosis Occurring up to and 21 Days Postoperatively
Standard care - nipple and areola necrosis
|
1 Participants
|
SECONDARY outcome
Timeframe: 21 days postoperativelyPopulation: There were 200 participants enrolled with 1 participant lost to follow-up immediately after surgery. All available results for this time point.
Assessment of participants developing a hematoma up to 21 days postoperatively for incisions treated with PICO compared with standard care dressings. All participants received both PICO and standard care dressings simultaneously during the course of the study; randomized to either right breast for PICO and left breast for standard of care OR right breast standard of care and left breast PICO.
Outcome measures
| Measure |
PICO Negative Pressure Wound Therapy/Standard of Care Dressing
n=199 Participants
PICO (single-use Negative Pressure Wound Therapy system \[su-NPWT\]) or standard of care dressing (sterile gauze adhesive strips) were randomized to either breast following bilateral breast reduction surgery for concomitant treatment to assess the aesthetic appearance and quality of resultant scar.
|
|---|---|
|
Number of Hematoma's Occurring up to and 21 Days Postoperatively
PICO - hematoma occurred
|
2 Participants
|
|
Number of Hematoma's Occurring up to and 21 Days Postoperatively
Standard care - hematoma occurred
|
3 Participants
|
SECONDARY outcome
Timeframe: 21 days postoperativelyPopulation: There were 200 participants enrolled with 1 participant lost to follow-up immediately after surgery. All available results for this time point.
Assessment of wound appearance demonstrating 100% wound closure at 21 days postoperatively for both PICO treatment and standard of care treatment. All participants received both PICO and standard care dressings simultaneously during the course of the study; randomized to either right breast for PICO and left breast for standard of care OR right breast standard of care and left breast PICO.
Outcome measures
| Measure |
PICO Negative Pressure Wound Therapy/Standard of Care Dressing
n=199 Participants
PICO (single-use Negative Pressure Wound Therapy system \[su-NPWT\]) or standard of care dressing (sterile gauze adhesive strips) were randomized to either breast following bilateral breast reduction surgery for concomitant treatment to assess the aesthetic appearance and quality of resultant scar.
|
|---|---|
|
Number of Wounds Showing 100% Closure Occurring up to and 21 Days Postoperatively
PICO - 100% wound closure
|
155 Participants
|
|
Number of Wounds Showing 100% Closure Occurring up to and 21 Days Postoperatively
Standard care - 100% wound closure
|
134 Participants
|
Adverse Events
PICO Negative Pressure Wound Therapy
Standard of Care Dressing Arm
Serious adverse events
| Measure |
PICO Negative Pressure Wound Therapy
n=200 participants at risk
PICO: Single-use Negative Pressure Wound Therapy system (su-NPWT)
|
Standard of Care Dressing Arm
n=200 participants at risk
Adhesive Skin Closure Strips, e.g. STERI-Strips, or alternatively a non-adherent dry dressing if Adhesive Skin Closure Strips was not deemed appropriate by the Principle Investigator at that center.
|
|---|---|---|
|
Skin and subcutaneous tissue disorders
Epidermolysis at T-junction/skin trifurcation point
|
0.50%
1/200 • Number of events 1 • Baseline through 90 days postoperatively.
|
0.50%
1/200 • Number of events 1 • Baseline through 90 days postoperatively.
|
|
Skin and subcutaneous tissue disorders
Fat necrosis
|
1.0%
2/200 • Number of events 3 • Baseline through 90 days postoperatively.
|
2.0%
4/200 • Number of events 4 • Baseline through 90 days postoperatively.
|
|
Skin and subcutaneous tissue disorders
Hematoma
|
0.00%
0/200 • Baseline through 90 days postoperatively.
|
0.50%
1/200 • Number of events 1 • Baseline through 90 days postoperatively.
|
|
Skin and subcutaneous tissue disorders
Infection and dehiscence
|
0.00%
0/200 • Baseline through 90 days postoperatively.
|
0.50%
1/200 • Number of events 1 • Baseline through 90 days postoperatively.
|
|
Surgical and medical procedures
Severe postoperative pain
|
0.00%
0/200 • Baseline through 90 days postoperatively.
|
0.50%
1/200 • Number of events 1 • Baseline through 90 days postoperatively.
|
Other adverse events
| Measure |
PICO Negative Pressure Wound Therapy
n=200 participants at risk
PICO: Single-use Negative Pressure Wound Therapy system (su-NPWT)
|
Standard of Care Dressing Arm
n=200 participants at risk
Adhesive Skin Closure Strips, e.g. STERI-Strips, or alternatively a non-adherent dry dressing if Adhesive Skin Closure Strips was not deemed appropriate by the Principle Investigator at that center.
|
|---|---|---|
|
Skin and subcutaneous tissue disorders
Delayed wound healing
|
25.0%
50/200 • Number of events 50 • Baseline through 90 days postoperatively.
|
35.0%
70/200 • Number of events 70 • Baseline through 90 days postoperatively.
|
Additional Information
Rachael Winter, Director of Clinical Operations
Smith & Nephew Inc
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: GT60