A prospective, randomized, intra-patient, comparative, open, multi-center study to evaluate the efficacy of a single use negative pressure wound therapy (NPWT) system* on the prevention of post-surgical incision healing complications in patients undergoing bilateral breast reduction surgery

Dr Robert Galiano, Dr Thomas Mustoe, Dr Jing Liu and Katherine Anne Piserchia, Northwestern Feinberg School of Medicine, Chicago, IL, USADr Risal Djohan, Margo Riha, Cleveland Clinic, Cleveland OH, USADr Jospeh H Shin, Dr Zachry Farris, Dr Teresa Benequista, Roger Swayze, Montefiore Medical Centre, Albert Einstein School of Medicine, Bronx, NY, USAProfessor Donald Hudson, Dr Kevin Adams, University of Cape Town, Cape Town, South Africa

Professor René Van der Hulst, Dr Jip Beugels, Dr Volkan Tanaydin, Dr John Sawor, Maastricht University Hospital, Maastricht, Netherlands and Viecuri Medical Center, Venlo, NetherlandsProfessor Franck Duteille, Yann Donnio, Patricia Yego, CHU de Nantes – Hôtel Dieu, University of Nantes, Nantes, FranceDr Robin Martin, Dr Elizabeth Huddleston, John Cockwill, Alan Rossington, Sarah Megginson, Smith & Nephew Wound Management, Hull, UK

AbstractIntroduction: Post-surgical incision healing complications can vary in severity from mild cases needing local wound care to serious cases with multiple reoperations and a high morbidity. Applying NPWT as a post-operative dressing for closed incisions has demonstrated a number of benefits.

Methods: 200 patients undergoing bilateral reduction mammoplasty and who were suitable for incisional NPWT were recruited. Each patient was treated with both PICO™ Single Use NPWT System and standard care for up to 14 days to enable a within patient comparison. Follow-up assessments were carried out to evaluate the difference in incision healing complications between PICO and standard care up to 21 days post-surgery (Primary Endpoint). Healing complications were defined as delayed healing (incision not 100% closed by 7 days), or occurrence of dehiscence or infection within 21 days. Differences in scar quality and aesthetic appearance were also assessed using The Patient and Observer Scar Assessment Scale (POSAS) and The Visual Analogue Scale (VAS) at 42 and 90 days.

Results: Significantly fewer overall healing complications had occurred by 21 days post surgery when treated with PICO compared to Standard Care (5%, p=0.004). Treatment with PICO resulted in significantly fewer incidences of dehiscence compared to standard care (32 patients (16.2%) v 52 patients (26.4%) by day 21 (p<0.001). Scar quality as measured by the VAS and POSAS scoring systems was shown to be significantly better on patients who received the PICO treatment than standard care, both at the 42 day and 90 day assessment (p<0.001).

Conclusion: Treatment of closed surgical incisions with a NPWT system in the form of PICO leads to a statistically significant reduction in incision healing complications, in particular a significant reduction in post-surgical dehiscence and a statistically significant improvement in scar quality within the first 3 months after the procedure.

Purpose of the studyThe purpose of the study was to assess the efficacy of the single use NPWT system (PICO) with regard to reduction of post-surgical 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.

*PICO Single Use Negative Pressure Wound Therapy System – Smith & Nephew Wound Management, Hull UK. This study was sponsored by Smith & Nephew. NCT01640366 http://clinicaltrials.gov/ct2/show/NCT01640366The author(s) of this abstract/poster may or may not be employed by Smith & Nephew. These materials are provided for educational use only and do not imply the authors have endorsed Smith & Nephew’s products in any way or that the techniques being used are endorsed or recommended by Smith & Nephew.

©2014 Smith & Nephew, Inc., All rights reserved. ™Trademark of Smith & Nephew. Registered US Patent and Trademark Office. All trademarks acknowledged. RA

PCCE-61-0914-NAE

Materials and methodsPICO Standard care

Pre-day 0 Day 0 Day 0-14

• Elegibility check

• Informed consent

• Randomization

• Dressing application

• Collecting baseline patient data

• Data collection

• Incision closed?

Day 21 Day 42 Day 90

• Data collection

• Incision assessment

• Data collection

• Incision assessment

• VAS+POSAS score

• Data collection

• Incision assessment

• VAS+POSAS score

Results

PICO vs. standard care (n=199):

• Group randomized to the PICO device yielded significantly fewer healing complications overall (5%) p=0.004, {95% CI 2.0% to 9.2%}.

• Group randomized to the PICO device yielded significant reduction in incidence of dehiscence: 32 patients (16.2%) v 52 patients (26.4%) p < 0.001, effect size=10% {95% CI 5.1% to 15.9%}.

• No significant difference in delayed healing at 7 days or 10 days: n= 102 v 103 at 7 days (p = 0.682, {95% CI -1.9% to 3.2%}) and n= 64 v 64 (p = 1.0, {95% CI -3.4% to 3.4%}).

• No significant differences in infection rate: n= 4 v 6 on SC, (p = 0.532, {95% CI = -1.9% to 4.3}).

• The incidence of delayed healing and dehiscence but not infection appeared to increase with increasing weight of resected tissue.

Figure 1. Within patient diference in VAS score (PICO/SC).

Figure 2. Within patient difference in POSAS score (PICO/SC)

ConclusionTreatment of closed surgical incisions with a NPWT system in the form of PICO leads to a statistically significant reduction in incision healing complications, in particular a significant reduction in post-surgical dehiscence. Healing complications such as delayed healing and dehiscence appear to be associated with an increase in weight of tissue resected. PICO treatment led to a statistically significant improvement in scar quality within the first 3 months after the procedure.

• Group randomized to the PICO device yielded significantly better scar quality as measured by VAS + POSAS, both at the 42 day and 90 day assessment (p<0.001).

• Fewer hypertrophic scars (immature and linear) at day 90 on patients treated with PICO compared with standard care.

• There were no keloid scars at day 90 on patients treated with PICO and 3 keloid scars on patients treated with standard care.

Day 42 PICO Standard careImmature hypertrophic scar (red) 36 (22.5%) 34 (23.3%)

Linear hypertrophic scar (red raised) 9 (5.6%) 13 (8.9%)

Minor keloid 1 (0.6%) 2 (1.4%)

Normal (flat/white) 114 (71.3%) 97 (66.4%)

Total 160 (100%) 146 (100%)

Day 90 PICO Standard care

Immature hypertrophic scar (red) 32 (18.4%) 38 (22.2%)

Linear hypertrophic scar (red raised) 19 (10.9%) 24 (14%)

Minor keloid 0 (0.0%) 3 (1.8%)

Normal (flat/white) 123 (70.7%) 106 (62.0%)

Total 174 (100%) 171 (100%)

Table 1. Scar type at follow up assessments

Clinical case Patient’s significant history:• 58 year-old caucasian female

Initial wound assessment:• BMI 29.4• Cup size F• CA distance: 31/29cm• Resection weight: 584/615g• Surgery time: 1h 25min

Treatment objective:• Bilateral reduction mammoplasty with Superomedial Pedicle technique• Vicryl and Monocryl sutures• PICO (R), standard care (L)

Outcome• At day 21 there was an superficial dehiscence (SD) on the standard care

side, no SD on PICO side• At day 42 follow-up the SD resolved• Overall, there was a subjective feeling that the PICO treated side was

healing better overall

PICO (right side) Standard care (left side)

Day 0

Day 7

Day 21

Day 42

Day 180

Day 365Effect of PICO vs standard care on post-surgical wound complications

Effect of tissue resection weight on complication rates

Visual Analog Scale (VAS) Scores

Patient and Observer Scar Assessment Scale (POSAS)

Standard care PICO

Totalcomplications

Delayed healing(7 days)

Delayed healing(10 days)

Dehiscence(21 days)

Infection(21 days)

Hea

ling

com

plic

atio

ns (%

)

70

60

50

40

30

20

10

0

Wou

nd h

ealin

g co

mpl

icat

ions

(%)

<500 n=68 <1000 n=82 <1500 n=31 >1500 n=18

Mean tissue resection weight per patient

90

80

70

60

50

40

30

20

10

0

Delayed healing PICO

Delayed healing standard card

Dehiscence PICO

Dehiscence standard card

Infection PICO

Infection standard card

With

in p

atie

nt d

iffer

ence

in V

AS

scor

e (P

ICO

/sta

ndar

d ca

re)

Total VAS score Global VAS score

Day 42 Day 90 Day 42 Day 90

5.0

2.5

0

-2.5

-5.0

-7.5

-10.0

Total observer score Total patient score

Day 42 Day 90 Day 42 Day 90With

in p

atie

nt d

iffer

ence

in P

OSA

S sc

ore

(PIC

O/s

tand

ard

care

) 40

20

-20

-40

0

0.004

N.S.

N.S.

<0.001

N.S.