A prospective, randomized, intra-patient, comparative, open, multi-centre study to evaluate the efficacy of a Single-Use Negative Pressure Wound Therapy (NPWT) System (PICO) on the prevention of postsurgical incision healing complications in patients undergoing reduction mammoplasty

A level of surgical site infection (SSI*s) and disruption of sutured tissue are
seemingly unavoidable complications following surgery. Different surgical
procedures carry different frequencies of SSI. For example, the incidences
range from 0.2% to 1.1% in primary hip joint replacement1; 1.1% in coronary
artery bypass grafts2; 2.5% for breast implant surgery3 or 6% in
gastrointestinal surgery4. Other negative outcomes from surgery, which may or
may not accompany infection, include delayed healing, wound dehiscence, tissue
necrosis, seroma and hematoma formation5. The severity of these complications
embraces mild cases needing local wound care and antibiotics to serious cases
with multiple reoperations and a high mortality rate4. Increased costs are the
inevitable consequence of SSI6 and there is intense interest in the
identification of risk factors for each procedure so that the costs and
mortality and morbidity can be reduced as far as possible in those patients who
have much higher than the average risks for developing an SSI7.
Negative Pressure Wound Therapy (NPWT) has been shown to be an effective
treatment in the management of acute and chronic open wounds8, but a relatively
new, emergent use of NPWT is its application as a post-operative dressing for
closed surgical incisions9. Post-operative oedema in the peri-wound tissue is
thought to limit tissue perfusion and high levels of wound fluid loss have been
correlated with increased risk of post-operative infection and dehiscence10.
These issues are particularly important in obese or immuno-compromised
patients. Application of NPWT to the closed wound; so called *incisional NPWT*
has been reported to improve patient comfort through reduced dressing change
and to reduce the period during which post-operative fluid discharges from the
incision. Gomoll et al., (2006) had no cases of wound breakdown in 35 patients
treated with NPWT using thin strips of polyurethane foam and NPWT set at
-75mmHg11. Stannard et al.,(2006) reported the interim results of a randomised
trial and found application of NPWT to 44 patients with draining haematomas
following high energy trauma reduced mean draining time from 3.1 to only 1.6
days (p=0.03)12. Similarly, in 44 additional patients with sutured incisions
over high energy trauma injuries, NPWT reduced drainage from 4.8 to 1.8 days
(p=0.02)12. In a subsequent report there was a statistically significant
reduction in wound infections in some 250 traumatic orthopaedic injuries13.
Reddix et al., (2009) found no post-op wound complications in 19 consecutive
high risk obese hip fracture patients (BMI>40 kg/m2) whose closed wounds were
treated with NPWT10,14. The application of NPWT to a clean closed incision has
other potential benefits related to its mechanisms of action which include
protecting the wound, splinting the incision, improved angiogenesis, increased
blood flow, reduced oedema, reduction in frequency of seroma and haemostasis15,
decreased interstitial fluid, removing infectious material and low frequency of
dressing changes16.
One area of surgery which has not yet been studied with respect to the effect
that incisional NPWT might have is in postsurgical complications following
breast reduction mammoplasty. A recent literature review found that bilateral
breast reduction is a relatively common surgery with a high risk of wound
healing complications. Analysis of 4 typical publications reveals a weighted
mean of 28.6% patients experience some measure of delayed wound healing (parts
unhealed by 2 weeks)17,18,19,20. It is apparent that delayed healing is
proportional to the patient*s BMI and it seems likely that the local history
and structure of the tissue is the cause of the increased susceptibility to
healing complications. This is a relatively high incidence of SSI wound healing
complication, albeit of relatively low severity. However, another clinical
outcome of compromised skin healing is the legacy of sub-optimal scars that are
cosmetically unacceptable, (such as those that are spreading, widened,
hypertrophic or keloid) or cause significant morbidity including pruritus, pain
and restriction of movement, particularly when over joints21. These cosmetic
and functional sequelae can have a significant impact on the patient*s
emotional wellbeing and this is certainly the case in medically necessary
reduction mammoplasty. Scars have been shown to cause high levels of anxiety
and self-consciousness and patients with scars often face aesthetic, physical,
psychological, and social consequences that result in substantial emotional and
financial costs22. A significant reduction in the frequency of wound healing
complications in breast reduction patients would be of demonstrable benefit.
Recently, Single-Use Negative Pressure Wound Therapy (NPWT) systems have been
introduced with regard to the reduction of postsurgical incision healing
complications such as infection and dehiscence. The single use Prevena* device
(Kinetic Concepts Inc., San Antonio, TX) was recently studied in primary hip
arthroplasty15. Single use disposable NPWT systems have the potential to reduce
the economic costs of securing improved outcomes of surgical incisions that
appear to be attainable using full sized NPWT systems11,14,13. They also have
the potential to represent a much less intrusive experience for the patient.
PICO is an example of a light weight single-use NPWT system which has just been
introduced into US clinical practice23.The purpose of this clinical study is to
determine whether the application of PICO during the immediate postoperative
treatment phase can reduce the incidence of delayed wound healing and infection
and to assess the medium-term aesthetic appearance and quality of the resultant
scar, in patients undergoing bilateral breast reduction surgery in comparison
to standard care.

12 REFERENCES

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deep surgical site infection after primary total hip arthroplasty: a systematic
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2. Baillot R, Cloutier D, Montalin L, et al. Impact of deep sternal wound
infection management with vacuum-assisted closure therapy followed by sternal
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cardio-thoracic surgery*: official journal of the European Association for
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Primary Objective:
To assess the difference in healing complications up to and 21 days
post-operatively between postsurgical incisions treated with PICO compared with
standard of care
Incision healing complications will include;
* Skin necrosis
* Nipple and Areola necrosis
* Hematoma
* Cellulitis
* Abscess
* Seroma
* Partial or superficial dehiscence
* Suture abscesses or extrusions (*spitting*)
* Infection (deep or superficial)
* Delayed wound healing

Secondary Objectives:
To assess the aesthetic appearance (cosmesis) and scar quality at Day 42, 90,
180 and 365 between post-surgical incision wounds treated with PICO compared
with standard care dressings using The Patient and Observer Scar Assessment
Scale (POSAS). The Visual Analogue Scale (VAS) and the Cutometer.

To assess the following aspects of functional performance of both dressings;

* Ease of application & removal
* Dressing wear time
* Patient comfort
* Patient pain
* Exudate management
* Patient acceptability

To assess the ease of operation of the PICO pump

To assess any changes in the surrounding skin condition over the course of
treatment and within the first 21 days between post-surgical incision wounds
treated with PICO compared with the standard care dressings, including the
amount of bruising and swelling, and the rate of resolution of the same

Assessment of a difference in the following economic assessments:

* Cost estimation per dressing change (health care professional and materials
used)
* Cost estimation for treatment per week and per episode of care
* Costs associated with additional interventions and specific interventions
(e.g. hospital re-admissions, additional surgical procedures, additional
antibiotics)

The study will comprise a prospective, randomised, intra-patient, comparative,
open-labelled, multi-centre study to determine the efficacy of a Single-Use
Negative Pressure Wound Therapy (NPWT) System (PICO) on the prevention of
postsurgical wound complications in patients undergoing bilateral reduction
mammoplasty.

PICO is a Single-Use Negative Pressure Wound Therapy (NPWT) System consisting
of a small portable pump, 2 lithium batteries, 2 dressings and 10 fixation
strips. PICO is capable of delivering 80mmHg (nominal) negative pressure to
the wound surface and managing low to moderate levels of exudate generated by
the wound. The kit is intended to be used for a maximum of 7 days. The
frequency of dressing changes, as indicated by clinical practice, may result in
therapy duration of the kit being less than 7 days.
Indications for use:
PICO is indicated for patients who would benefit from a suction device
(negative pressure wound therapy) as it may promote wound healing via removal
of low to moderate levels of exudate and infectious materials. PICO Single-Use
Negative Pressure Wound Therapy System is suitable for use in both a hospital
and home care setting.
Examples of appropriate wound types include:

* Acute
* Chronic
* Flaps and grafts
* Incision sites
* Partial-thickness burns
* Sub acute and dehisced wounds
* Traumatic
* Ulcers (such as diabetic or pressure)

Contraindications:

PICO is contraindicated for:

* Patients with malignancy in the wound bed or margins of the wound (except
in palliative care to enhance quality of life).
* Previously confirmed and untreated osteomyelitis.
* Non-enteric and unexplored fistulas.
* Use on necrotic tissue with eschar present.
* Use over exposed blood vessels, nerves or organs.
* Exposed anastomotic sites.

Common reactions to any type of dressing used may include redness, pain,
itching or burning at the dressing site. Occasionally a reaction to the
adhesive layer (tape) or components that make up the dressings may occur which
also causes redness, pain, burning, itching, blistering or skin stripping at
the site. If this occurs, the dressings will be removed and an alternative
dressing used or without dressing.
The use of the cutometer, which is a non-invasive measuring device, will have
no risk at all to the patient.