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The purpose of this study is to see if the use of a single-use negative pressure wound therapy system (NPWT) will have an effect on the reduction of post-surgical incision healing complications following breast reduction surgery and to assess the medium-term aesthetic appearance and quality of the resultant scar, compared with standard of care dressings.
The aim of the present study is to assess the efficacy and cost-effectiveness of the Single-Use Negative Pressure Wound Therapy (NPWT) system (PICO) with regard to the reduction of postsurgical incision healing complications during the immediate postoperative treatment phase, and to assess the medium-term aesthetic appearance and quality of the resultant scar, in patients undergoing reduction mammoplasty, compared to standard care.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| PICO negative pressure | Experimental | Single-use Negative Pressure Wound Therapy |
|
| Standard of care dressing arm | No Intervention | Sterile gauze adhesive strips |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PICO | Device | Single-use Negative Pressure Wound Therapy System |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants Experiencing Incision Healing Complications up to Day 21 Postoperatively | 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:
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. | 21 days postoperatively |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants Experiencing Postsurgical Incision Healing Complications (Dehiscence) Occurring up to Day 21 Postoperatively | 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Robert D Galiano, MD | Northwestern University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Northwestern University Feinberg School of Medicine | Chicago | Illinois | 60611 | United States | ||
| Montefiore |
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There were 200 participants enrolled in this study.
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
200 participants were enrolled, but 1 subject never attended any follow-up visits and was thus excluded from all data.
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Number of Participants Experiencing Incision Healing Complications up to Day 21 Postoperatively | 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:
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. | There were 200 participants enrolled with 1 participant lost to follow-up immediately after surgery. | Posted | Number | participants | 21 days postoperatively |
|
Baseline through 90 days postoperatively.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | PICO Negative Pressure Wound Therapy | PICO: Single-use Negative Pressure Wound Therapy system (su-NPWT) |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Epidermolysis at T-junction/skin trifurcation point | Skin and subcutaneous tissue disorders | MedDRA (10.0) | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Delayed wound healing | Skin and subcutaneous tissue disorders | MedDRA (10.0) | Systematic Assessment |
There was one site (68 enrolled participants in total) in which the data were analyzed separately due to issues at the site. This data was also analyzed and included in the overall totals for baseline characteristics and outcome measures.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Rachael Winter, Director of Clinical Operations | Smith & Nephew Inc | +44 1482 673475 | rachael.winter@smith-nephew.com |
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| ID | Term |
|---|---|
| D000072836 | Surgical Wound |
| ID | Term |
|---|---|
| D014947 | Wounds and Injuries |
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| 21 days postoperatively |
| Number of Participants Experiencing Postsurgical Incision Healing Complications (Infection) Occurring up to Day 21 Postoperatively | 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. | 21 days postoperatively |
| Number of Participants Experiencing Postsurgical Incision Healing Complications (Delayed Healing) Occurring Within 7 Days Postoperatively | 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. | Within 7 days postoperatively |
| Number of Participants Experiencing Postsurgical Incision Healing Complications (Delayed Healing) Occurring Within 10 Days Postoperatively | 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. | Within 10 days postoperatively |
| Aesthetic Appearance (Cosmesis) and Scar Quality at 90 Days Postoperatively | 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. | 90 days postoperatively |
| Number of Skin, Nipple and Areola Necrosis Occurring up to and 21 Days Postoperatively | 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. | 21 days postoperatively |
| Number of Hematoma's Occurring up to and 21 Days Postoperatively | 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. | 21 days postoperatively |
| Number of Wounds Showing 100% Closure Occurring up to and 21 Days Postoperatively | 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. | 21 days postoperatively |
| The Bronx |
| New York |
| 10461 |
| United States |
| Cleveland Clinic | Cleveland | Ohio | 44195 | United States |
| CHU de Nantes Hôtel Dieu | Nantes | 44093 | France |
| Academisch Ziekenhuis Maastricht (AZM) | Maastricht | 6202 | Netherlands |
| University of Cape Town | Cape Town | South Africa |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| BMI | Mean | Inter-Quartile Range | kg/m^2 |
|
| Administration of Prophylactic Antibiotics | Count of Participants | Participants |
|
| Surgical Technique | Count of Participants | Participants |
|
| Duration of Surgery | Mean | Inter-Quartile Range | minutes |
|
| Mean Tissue Resection Weight | Count of Participants | 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.
|
|
| Secondary | Number of Participants Experiencing Postsurgical Incision Healing Complications (Dehiscence) Occurring up to Day 21 Postoperatively | 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. | There were 200 participants enrolled with 1 participant lost to follow-up immediately after surgery. All available results at this time point. | Posted | Number | participants | 21 days postoperatively |
|
|
|
| Secondary | Number of Participants Experiencing Postsurgical Incision Healing Complications (Infection) Occurring up to Day 21 Postoperatively | 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. | There were 200 participants enrolled with 1 participant lost to follow-up immediately after surgery. All available results at this time point. | Posted | Number | participants | 21 days postoperatively |
|
|
|
| Secondary | Number of Participants Experiencing Postsurgical Incision Healing Complications (Delayed Healing) Occurring Within 7 Days Postoperatively | 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. | There were 200 participants enrolled with 1 participant lost to follow-up immediately after surgery. | Posted | Number | participants | Within 7 days postoperatively |
|
|
|
| Secondary | Number of Participants Experiencing Postsurgical Incision Healing Complications (Delayed Healing) Occurring Within 10 Days Postoperatively | 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. | There were 200 participants enrolled with 1 participant lost to follow-up immediately after surgery. | Posted | Number | participants | Within 10 days postoperatively |
|
|
|
| Secondary | Aesthetic Appearance (Cosmesis) and Scar Quality at 90 Days Postoperatively | 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. | There were 200 participants enrolled with 1 participant lost to follow-up immediately after surgery. All available results at the 90 day time point. | Posted | Median | Inter-Quartile Range | score on a scale | 90 days postoperatively |
|
|
|
| Secondary | Number of Skin, Nipple and Areola Necrosis Occurring up to and 21 Days Postoperatively | 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. | There were 200 participants enrolled with 1 participant lost to follow-up immediately after surgery. All available results for this time point. | Posted | Count of Participants | Participants | 21 days postoperatively |
|
|
|
| Secondary | Number of Hematoma's Occurring up to and 21 Days Postoperatively | 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. | There were 200 participants enrolled with 1 participant lost to follow-up immediately after surgery. All available results for this time point. | Posted | Count of Participants | Participants | 21 days postoperatively |
|
|
|
| Secondary | Number of Wounds Showing 100% Closure Occurring up to and 21 Days Postoperatively | 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. | There were 200 participants enrolled with 1 participant lost to follow-up immediately after surgery. All available results for this time point. | Posted | Count of Participants | Participants | 21 days postoperatively |
|
|
|
| 0 |
| 200 |
| 2 |
| 200 |
| 50 |
| 200 |
| EG001 | Standard of Care Dressing Arm | 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. | 0 | 200 | 7 | 200 | 70 | 200 |
| Fat necrosis | Skin and subcutaneous tissue disorders | MedDRA (10.0) | Systematic Assessment |
|
| Hematoma | Skin and subcutaneous tissue disorders | MedDRA (10.0) | Systematic Assessment |
|
| Infection and dehiscence | Skin and subcutaneous tissue disorders | MedDRA (10.0) | Systematic Assessment |
|
| Severe postoperative pain | Surgical and medical procedures | MedDRA (10.0) | Systematic Assessment |
|
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| Standard care with wound dehiscence |
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| Standard care without wound dehiscence |
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| Standard care with wound infection |
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| Standard care without wound infection |
|
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| Title | Measurements |
|---|---|
|
| Standard care without delayed healing |
|
| Title | Measurements |
|---|---|
|
| Standard care without delayed healing |
|
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| PICO - POSAS Observer Total |
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| Standard care - POSAS Observer Total |
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| PICO - POSAS Patient Total |
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| Standard care - POSAS Patient Total |
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| PICO - nipple and areola necrosis |
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| Standard care - nipple and areola necrosis |
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