Delayed Healing
Conditions
Keywords
surgical incision, reduction mammoplasty, healing complications, negative pressure wound therapy
Brief summary
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.
Detailed description
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.
Interventions
DEVICEPICO
Single-use Negative Pressure Wound Therapy System
Sponsors
Smith & Nephew, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Female patient's ≥ 18 years old * The patient is able to understand the trial and is willing to consent to the trial * Patient has undergone an elective surgical procedure for bilateral reduction mammoplasty * Patients postsurgical incisions are of similar length
Exclusion criteria
* Pregnant or lactating females * Patients on steroids or other immune modulators known to impact healing which may affect scar appearance * Patients with tattoos in the area of the incisions * Patients with skin conditions (Cutis laxa etc.) that would result in poor healing or widened scars * Patients with a known significant history of scar problems i.e. hypertrophic scaring or keloids * Patients who in the opinion of the investigator may not complete the study for any reason * Patients with a known history of poor compliance with medical treatment * Patients who have participated in this trial previously and who were withdrawn * Patients with known allergies to product components (silicone adhesives and polyurethane films (direct contact with wound), acrylic adhesives (direct contact with skin), polyethylene fabrics and super-absorbent powders (polyacrylates) (within the dressing) * Incisions that are actively bleeding * Exposure of blood vessels, organs, bone or tendon at the base of the reference wound * Incisions \> 12 inches (30cm) max linear dimension
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants Experiencing Incision Healing Complications up to Day 21 Postoperatively | 21 days 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: 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants Experiencing Postsurgical Incision Healing Complications (Infection) Occurring up to Day 21 Postoperatively | 21 days 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. |
| Number of Participants Experiencing Postsurgical Incision Healing Complications (Delayed Healing) Occurring Within 7 Days Postoperatively | 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. |
| Number of Participants Experiencing Postsurgical Incision Healing Complications (Delayed Healing) Occurring Within 10 Days Postoperatively | 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. |
| Number of Participants Experiencing Postsurgical Incision Healing Complications (Dehiscence) Occurring up to Day 21 Postoperatively | 21 days 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. |
| Number of Skin, Nipple and Areola Necrosis Occurring up to and 21 Days Postoperatively | 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. |
| Number of Hematoma's Occurring up to and 21 Days Postoperatively | 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. |
| Number of Wounds Showing 100% Closure Occurring up to and 21 Days Postoperatively | 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. |
| Aesthetic Appearance (Cosmesis) and Scar Quality at 90 Days Postoperatively | 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. |
Countries
France, Netherlands, South Africa, United States
Participant flow
Recruitment details
There were 200 participants enrolled in this study.
Participants by arm
| Arm | Count |
|---|---|
| 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. | 199 |
| Total | 199 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Lost to Follow-up | 5 |
| Overall Study | Protocol Violation | 16 |
| Overall Study | Withdrawal by Subject | 1 |
Baseline characteristics
| Characteristic | PICO Negative Pressure Wound Therapy/Standard of Care Dressing |
|---|---|
| Administration of Prophylactic Antibiotics No | 11 Participants |
| Administration of Prophylactic Antibiotics Yes | 188 Participants |
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 0 Participants |
| Age, Categorical Between 18 and 65 years | 199 Participants |
| BMI | 30.0 kg/m^2 |
| Duration of Surgery | 168.3 minutes |
| Mean Tissue Resection Weight 1000 - <1500 g | 31 Participants |
| Mean Tissue Resection Weight > 1500 g | 18 Participants |
| Mean Tissue Resection Weight 500 - <1000 g | 82 Participants |
| Mean Tissue Resection Weight < 500 g | 68 Participants |
| Race/Ethnicity, Customized African American | 50 Participants |
| Race/Ethnicity, Customized Caucasian | 66 Participants |
| Race/Ethnicity, Customized Hispanic | 22 Participants |
| Race/Ethnicity, Customized Other | 55 Participants |
| Region of Enrollment France | 8 participants |
| Region of Enrollment Netherlands | 33 participants |
| Region of Enrollment South Africa | 68 participants |
| Region of Enrollment United States | 91 participants |
| Sex: Female, Male Female | 199 Participants |
| Sex: Female, Male Male | 0 Participants |
| Surgical Technique Inferior pedicle (with inverted T incision) | 55 Participants |
| Surgical Technique Other | 118 Participants |
| Surgical Technique Superior and inferior pedicle | 6 Participants |
| Surgical Technique Superior pedicle | 18 Participants |
| Surgical Technique Superior pedicle and superomedial | 2 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 200 | 0 / 200 |
| other Total, other adverse events | 50 / 200 | 70 / 200 |
| serious Total, serious adverse events | 2 / 200 | 7 / 200 |
Outcome results
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: 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.
Time frame: 21 days postoperatively
Population: There were 200 participants enrolled with 1 participant lost to follow-up immediately after surgery.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| PICO Negative Pressure Wound Therapy/Standard of Care Dressing | Number of Participants Experiencing Incision Healing Complications up to Day 21 Postoperatively | PICO treatment without healing complications | 86 participants |
| PICO Negative Pressure Wound Therapy/Standard of Care Dressing | Number of Participants Experiencing Incision Healing Complications up to Day 21 Postoperatively | Standard care with healing complications | 123 participants |
| PICO Negative Pressure Wound Therapy/Standard of Care Dressing | Number of Participants Experiencing Incision Healing Complications up to Day 21 Postoperatively | PICO treatment with healing complications | 113 participants |
| PICO Negative Pressure Wound Therapy/Standard of Care Dressing | Number of Participants Experiencing Incision Healing Complications up to Day 21 Postoperatively | Standard care without healing complications | 76 participants |
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.
Time frame: 90 days postoperatively
Population: There were 200 participants enrolled with 1 participant lost to follow-up immediately after surgery. All available results at the 90 day time point.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| PICO Negative Pressure Wound Therapy/Standard of Care Dressing | Aesthetic Appearance (Cosmesis) and Scar Quality at 90 Days Postoperatively | Standard care - POSAS Patient Total | 19 score on a scale |
| PICO Negative Pressure Wound Therapy/Standard of Care Dressing | Aesthetic Appearance (Cosmesis) and Scar Quality at 90 Days Postoperatively | PICO - VAS Global Assessment | 3 score on a scale |
| PICO Negative Pressure Wound Therapy/Standard of Care Dressing | Aesthetic Appearance (Cosmesis) and Scar Quality at 90 Days Postoperatively | Standard care - VAS Global Assessment | 3 score on a scale |
| PICO Negative Pressure Wound Therapy/Standard of Care Dressing | Aesthetic Appearance (Cosmesis) and Scar Quality at 90 Days Postoperatively | PICO - POSAS Observer Total | 16 score on a scale |
| PICO Negative Pressure Wound Therapy/Standard of Care Dressing | Aesthetic Appearance (Cosmesis) and Scar Quality at 90 Days Postoperatively | Standard care - POSAS Observer Total | 18 score on a scale |
| PICO Negative Pressure Wound Therapy/Standard of Care Dressing | Aesthetic Appearance (Cosmesis) and Scar Quality at 90 Days Postoperatively | PICO - POSAS Patient Total | 15 score on a scale |
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.
Time frame: 21 days postoperatively
Population: There were 200 participants enrolled with 1 participant lost to follow-up immediately after surgery. All available results for this time point.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| PICO Negative Pressure Wound Therapy/Standard of Care Dressing | Number of Hematoma's Occurring up to and 21 Days Postoperatively | PICO - hematoma occurred | 2 Participants |
| PICO Negative Pressure Wound Therapy/Standard of Care Dressing | Number of Hematoma's Occurring up to and 21 Days Postoperatively | Standard care - hematoma occurred | 3 Participants |
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.
Time frame: 21 days postoperatively
Population: There were 200 participants enrolled with 1 participant lost to follow-up immediately after surgery. All available results at this time point.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| PICO Negative Pressure Wound Therapy/Standard of Care Dressing | Number of Participants Experiencing Postsurgical Incision Healing Complications (Dehiscence) Occurring up to Day 21 Postoperatively | PICO treatment without wound dehiscence | 165 participants |
| PICO Negative Pressure Wound Therapy/Standard of Care Dressing | Number of Participants Experiencing Postsurgical Incision Healing Complications (Dehiscence) Occurring up to Day 21 Postoperatively | PICO treatment with wound dehiscence | 32 participants |
| PICO Negative Pressure Wound Therapy/Standard of Care Dressing | Number of Participants Experiencing Postsurgical Incision Healing Complications (Dehiscence) Occurring up to Day 21 Postoperatively | Standard care with wound dehiscence | 52 participants |
| PICO Negative Pressure Wound Therapy/Standard of Care Dressing | Number of Participants Experiencing Postsurgical Incision Healing Complications (Dehiscence) Occurring up to Day 21 Postoperatively | Standard care without wound dehiscence | 145 participants |
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.
Time frame: Within 10 days postoperatively
Population: There were 200 participants enrolled with 1 participant lost to follow-up immediately after surgery.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| PICO Negative Pressure Wound Therapy/Standard of Care Dressing | Number of Participants Experiencing Postsurgical Incision Healing Complications (Delayed Healing) Occurring Within 10 Days Postoperatively | PICO treatment without delayed healing | 135 participants |
| PICO Negative Pressure Wound Therapy/Standard of Care Dressing | Number of Participants Experiencing Postsurgical Incision Healing Complications (Delayed Healing) Occurring Within 10 Days Postoperatively | PICO treatment with delayed healing | 64 participants |
| PICO Negative Pressure Wound Therapy/Standard of Care Dressing | Number of Participants Experiencing Postsurgical Incision Healing Complications (Delayed Healing) Occurring Within 10 Days Postoperatively | Standard care with delayed healing | 64 participants |
| PICO Negative Pressure Wound Therapy/Standard of Care Dressing | Number of Participants Experiencing Postsurgical Incision Healing Complications (Delayed Healing) Occurring Within 10 Days Postoperatively | Standard care without delayed healing | 135 participants |
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.
Time frame: Within 7 days postoperatively
Population: There were 200 participants enrolled with 1 participant lost to follow-up immediately after surgery.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| PICO Negative Pressure Wound Therapy/Standard of Care Dressing | Number of Participants Experiencing Postsurgical Incision Healing Complications (Delayed Healing) Occurring Within 7 Days Postoperatively | PICO treatment with delayed healing | 102 participants |
| PICO Negative Pressure Wound Therapy/Standard of Care Dressing | Number of Participants Experiencing Postsurgical Incision Healing Complications (Delayed Healing) Occurring Within 7 Days Postoperatively | PICO treatment without delayed healing | 97 participants |
| PICO Negative Pressure Wound Therapy/Standard of Care Dressing | Number of Participants Experiencing Postsurgical Incision Healing Complications (Delayed Healing) Occurring Within 7 Days Postoperatively | Standard care with delayed healing | 103 participants |
| PICO Negative Pressure Wound Therapy/Standard of Care Dressing | Number of Participants Experiencing Postsurgical Incision Healing Complications (Delayed Healing) Occurring Within 7 Days Postoperatively | Standard care without delayed healing | 96 participants |
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.
Time frame: 21 days postoperatively
Population: There were 200 participants enrolled with 1 participant lost to follow-up immediately after surgery. All available results at this time point.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| PICO Negative Pressure Wound Therapy/Standard of Care Dressing | Number of Participants Experiencing Postsurgical Incision Healing Complications (Infection) Occurring up to Day 21 Postoperatively | PICO treatment with wound infection | 4 participants |
| PICO Negative Pressure Wound Therapy/Standard of Care Dressing | Number of Participants Experiencing Postsurgical Incision Healing Complications (Infection) Occurring up to Day 21 Postoperatively | PICO treatment without wound infection | 193 participants |
| PICO Negative Pressure Wound Therapy/Standard of Care Dressing | Number of Participants Experiencing Postsurgical Incision Healing Complications (Infection) Occurring up to Day 21 Postoperatively | Standard care with wound infection | 6 participants |
| PICO Negative Pressure Wound Therapy/Standard of Care Dressing | Number of Participants Experiencing Postsurgical Incision Healing Complications (Infection) Occurring up to Day 21 Postoperatively | Standard care without wound infection | 191 participants |
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.
Time frame: 21 days postoperatively
Population: There were 200 participants enrolled with 1 participant lost to follow-up immediately after surgery. All available results for this time point.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| PICO Negative Pressure Wound Therapy/Standard of Care Dressing | Number of Skin, Nipple and Areola Necrosis Occurring up to and 21 Days Postoperatively | PICO - skin necrosis | 2 Participants |
| PICO Negative Pressure Wound Therapy/Standard of Care Dressing | Number of Skin, Nipple and Areola Necrosis Occurring up to and 21 Days Postoperatively | Standard care - skin necrosis | 7 Participants |
| PICO Negative Pressure Wound Therapy/Standard of Care Dressing | Number of Skin, Nipple and Areola Necrosis Occurring up to and 21 Days Postoperatively | PICO - nipple and areola necrosis | 2 Participants |
| PICO Negative Pressure Wound Therapy/Standard of Care Dressing | Number of Skin, Nipple and Areola Necrosis Occurring up to and 21 Days Postoperatively | Standard care - nipple and areola necrosis | 1 Participants |
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.
Time frame: 21 days postoperatively
Population: There were 200 participants enrolled with 1 participant lost to follow-up immediately after surgery. All available results for this time point.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| PICO Negative Pressure Wound Therapy/Standard of Care Dressing | Number of Wounds Showing 100% Closure Occurring up to and 21 Days Postoperatively | PICO - 100% wound closure | 155 Participants |
| PICO Negative Pressure Wound Therapy/Standard of Care Dressing | Number of Wounds Showing 100% Closure Occurring up to and 21 Days Postoperatively | Standard care - 100% wound closure | 134 Participants |