infection prevention

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Background and objective: Perineal wound infection following colorectal surgery has a significant impact on postoperative recovery, often causing delayed discharge, transfer to the Intensive Care Unit, readmissions, and pain and discomfort to the patient. The risk factors for perineal wound infection vary significantly throughout the literature. The objective of this study was to identify the principal risk factors associated with perineal wound infection after rectal surgery at two academic institutions. Methods: We performed a retrospective review of 109 patients undergoing colorectal surgery at two academic institutions between July 2009 and June 2012. The primary outcome of the study was the incidence of perineal wound infection after colorectal surgery with perineal wound incision. Results: Sixty (55%) of patients were male and the mean age of all patients was 56.6 years (range: 17-89 years). Sixty- five (57.5%) patients underwent neoadjuvant chemoradiation. Out of 109 patients, 23 (21.1%) had a perineal wound infection following surgery. In univariate analyses, hypertension (p=0.005), a diagnosis of cancer (p=0.019), type of approach used (p=0.005), type of surgery (p=0.014) and neoadjuvant chemoradiation (p=0.040) were significantly associated with wound infection. Additionally, the type of prophylactic antibiotic administered was found to be significant (p=0.000). In a multivariate analysis performed hypertension and neoadjuvant chemoradiation were found to be significant (p=0.044 and p=0.016, respectively). Conclusion: Neoadjuvant chemoradiation and hypertension are high risk factors for perineal wound infection in patients undergoing rectal surgery. In addition, when compared to fluoroquinolones plus metronidazole or carbapenems, β-lactam used as a preventive antibiotic has a higher rate of infection. This suggests a higher resistance rate to β-lactams in this particular patient population and, therefore, consideration should be given to other antibiotics. Finally, carbapenems and fluoroquinolones plus metronidazole performed equally well in reducing the rate of postoperative perineal wound infection, in comparison to β-lactams. Life Sciences, Llc; "Apparatus & Method for Wound Infection Prevention" in Patent Application Approval Process Physician Business Week (Sep 30, 2014): 591.

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Page 1: Infection Prevention

Background and objective: Perineal wound infection following colorectal surgery has a significant

impact on postoperative recovery, often causing delayed discharge, transfer to the Intensive Care Unit,

readmissions, and pain and discomfort to the patient. The risk factors for perineal wound infection vary

significantly throughout the literature. The objective of this study was to identify the principal risk

factors associated with perineal wound infection after rectal surgery at two academic institutions.

Methods: We performed a retrospective review of 109 patients undergoing colorectal surgery at two

academic institutions between July 2009 and June 2012. The primary outcome of the study was the

incidence of perinealwound infection after colorectal surgery with perineal wound incision.

Results: Sixty (55%) of patients were male and the mean age of all patients was 56.6 years (range:

17-89 years). Sixty- five (57.5%) patients underwent neoadjuvant chemoradiation. Out of 109 patients,

23 (21.1%) had a perinealwound infection following surgery. In univariate analyses, hypertension

(p=0.005), a diagnosis of cancer (p=0.019), type of approach used (p=0.005), type of surgery

(p=0.014) and neoadjuvant chemoradiation (p=0.040) were significantly associated with wound

infection. Additionally, the type of prophylactic antibiotic administered was found to be significant

(p=0.000). In a multivariate analysis performed hypertension and neoadjuvant chemoradiation were

found to be significant (p=0.044 and p=0.016, respectively).

Conclusion: Neoadjuvant chemoradiation and hypertension are high risk factors for perineal wound

infection in patients undergoing rectal surgery. In addition, when compared to fluoroquinolones plus

metronidazole or carbapenems, β-lactam used as a preventive antibiotic has a higher rate of infection.

This suggests a higher resistance rate to β-lactams in this particular patient population and, therefore,

consideration should be given to other antibiotics. Finally, carbapenems and fluoroquinolones plus

metronidazole performed equally well in reducing the rate of postoperative perineal wound infection,

in comparison to β-lactams.

Life Sciences, Llc; "Apparatus & Method for Wound Infection Prevention" in Patent Application Approval ProcessPhysician Business Week (Sep 30, 2014): 591.Turn on hit highlighting for speaking browsers by selecting the Enter buttonHide highlighting

Abstract (summary)TranslateAbstract

In addition to the background information obtained for this patent application, NewsRx journalists also

obtained the inventors' summary information for this patent application: "A wound healing device for

applying within an incision orwound is disclosed. The wound healing device comprises: a first portion

(e.g., a dressing, bandage, etc.) that is applied over the incision or wound (e.g., open or closed),

wherein the first portion comprises a fluid absorbent material (e.g., any natural or synthetic material,

Page 2: Infection Prevention

such but not limited to: cotton, Teflon, nylon, packing material, etc.); a second portion (e.g., strip, loop,

tab, cord, appendage, tentacle, finger, etc.) that is in fluid communication and comprises a fluid

absorbent material or materials material (e.g., any natural or synthetic material, such but not limited

to: cotton, Teflon, nylon, packing material, etc.) with the first portion at a first end of the second

portion and a second end of the second portion that is positioned within the wound in the

subcutaneous skin layer, wherein the second portion comprises a fluid absorbent material (e.g., any

natural or synthetic material, such but not limited to cotton, nylon, packing material, etc.).

"A method for wound healing that greatly reduces the chances for infection of an incision

or wound (e.g., open or closed) of a patient is disclosed. The method comprises: inserting one end of at

least one fluid absorbing material (e.g., any natural or synthetic material, such but not limited to

cotton, Teflon, nylon, packing material, etc.) inside the incision or wound; positioning a second end of

said at least one fluid absorbing material (e.g., strip, loop, tab, cord, appendage, tentacle, finger, etc.)

which in itself permits the inclusion of air into the incision, to be in fluid communication with another

fluid absorbent material (e.g., a dressing, bandage, etc. and also comprising any natural or synthetic

material, such but not limited to cotton, Teflon, nylon, packing material, etc.) that is positioned

external of the patient and over top of the incision or wound; and maintaining said at least one fluid

absorbing material and said another fluid absorbent material within and top of the incision

or wound respectively, for approximately 1-3 days for conveying fluid out of the incision or wound and

into the another fluid absorbent material. Because of the communication between the (e.g., strip, loop,

tab, cord, appendage, tentacle, finger, etc.) and the outer dressing, the (e.g., strip, loop, tab, cord,

appendage, tentacle, finger, etc.) cannot be accidentally left inside the patient.

"A method for wound healing that greatly reduces the chances for infection of an incision

or wound (e.g., open or closed) of a patient is disclosed. The method comprises: forming at least one

strand of a fluid absorbing material (e.g., any natural or synthetic material, such but not limited to

cotton, Teflon, nylon, packing material, etc.); inserting a first end of said at least one strand (e.g., strip,

loop, tab, cord, appendage, tentacle, finger, etc.) inside the incision orwound; positioning a second free

end of said at least one strand to be positioned external of the patient; and maintaining said first end

of said at least one strand within the incision or wound for approximately 1-3 days for conveying fluid

out of the incision or wound and into said strand. BRIEF DESCRIPTION OF SEVERAL VIEWS OF THE

DRAWINGS

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Page 3: Infection Prevention

2014 SEP 30 (NewsRx) -- By a News Reporter-Staff News Editor at Physician Business Week -- A patent

application by the inventors Fulmes, Mychailo (Brooklyn, NY); Turkevych, Ihor (Southampton, PA);

McGough, Michael (Southampton, PA), filed on February 28, 2014, was made available online on

September 18, 2014, according to news reporting originating from Washington, D.C., by NewsRx

correspondents.

This patent application is assigned to Life Sciences, Llc.

The following quote was obtained by the news editors from the background information supplied by

the inventors: "The present invention relates generally to apparatus and methods for treating wounds,

and more particularly, to an apparatus and method for healing closed incisions following surgery.

"America wastes over a billion dollars annually, on post-operative surgical site infection expenses.

These surgeries have an acknowledged overall infection rate of between 15%-30%. Surgical

site infection slows the recovery rate for patients and adds additional health costs with prolonged

hospital treatment, additional home care, physician office and emergency room visits expenses.

"Typically, physicians often respond to the risk of wound infection with the 'open wound' technique,

subjecting patients to psychological torment of the patient knowing they have an open wound,

restricting them from normal activity. The patient is left with a hole in their body open to the outside;

which requires additional health maintenance including additional dressing changes by visiting nurses,

additional physician consultation and additional high cost of vacuum device usually for a week or

longer.

"Physicians, attempts to avoid an open wound, will often install a drainage device in the patient. This is

accomplished by placing a plastic tube into the patient, horizontally along the fascia layer and closing

the wound around the tube. The most common drains; the 'J-Drain', and 'Penrose Drain', do not

remove fluid from all three layers of skin, have a tendency to clog up and can even increase the

production of additional fluid in patients; at times making theinfection and recovery issues worse. The

drains must then eventually be removed by surgeon, sometimes weeks after surgery. Research shows

these drains have a poor rate of success with some studies showing an actual increase in patient

complications.

"Patients enduring the traditional old fashioned healing systems frequently require weeks to recover,

extensive follow-up treatments and procedures and have increased the risk of complications and even

death.

Page 4: Infection Prevention

"Recently, open wound 'negative pressure' treatments are now also being touted as the answer for

closed incision as well as open wound infection preventative treatments; this treatment simply

removes excess fluid from cutaneous areas from the outer skin level. Negative pressure treatments fail

to effectively address the underlining cause of surgical site infection (SSI) in closed incisions. The

negative pressure VAC (vacuum) systems are also very expensive and are physician and nurse-labor

intensive. The data surrounding the VAC systems appears to be mixed and studies appear to show that

these systems involve patients with fewer high risk factors prior to surgery.

"SSI infections may occur from the following, but not limited to: colorectal, general surgery, OBGYN,

urology, vascular, neurosurgery and other procedures. The incisions or wounds closed following their

respective surgeries are susceptible to high infection rates and slow patient recovery periods which

also impact the physician, staff, hospital, insurer, etc. Moreover, SSI costs hospitals billions of dollars

every year in the U.S. and insurance companies do not reimburse hospitals for maladies caused

by infection, and corresponding complications, due to surgical site infection.

"Thus, there remains a need for an apparatus and associated method that enables the physician to

close the woundwithout significantly increasing the risk of surgical site infection to the patient, thereby

being able to safely close more patients following surgery and improving their lives. The apparatus and

associated method is easy to remove from the patient and is a cost effective solution.

"All references cited herein are incorporated herein by reference in their entireties."

In addition to the background information obtained for this patent application, NewsRx journalists also

obtained the inventors' summary information for this patent application: "A wound healing device for

applying within an incision orwound is disclosed. The wound healing device comprises: a first portion

(e.g., a dressing, bandage, etc.) that is applied over the incision or wound (e.g., open or closed),

wherein the first portion comprises a fluid absorbent material (e.g., any natural or synthetic material,

such but not limited to: cotton, Teflon, nylon, packing material, etc.); a second portion (e.g., strip, loop,

tab, cord, appendage, tentacle, finger, etc.) that is in fluid communication and comprises a fluid

absorbent material or materials material (e.g., any natural or synthetic material, such but not limited

to: cotton, Teflon, nylon, packing material, etc.) with the first portion at a first end of the second

portion and a second end of the second portion that is positioned within the wound in the

subcutaneous skin layer, wherein the second portion comprises a fluid absorbent material (e.g., any

natural or synthetic material, such but not limited to cotton, nylon, packing material, etc.).

"A method for wound healing that greatly reduces the chances for infection of an incision

or wound (e.g., open or closed) of a patient is disclosed. The method comprises: inserting one end of at

Page 5: Infection Prevention

least one fluid absorbing material (e.g., any natural or synthetic material, such but not limited to

cotton, Teflon, nylon, packing material, etc.) inside the incision or wound; positioning a second end of

said at least one fluid absorbing material (e.g., strip, loop, tab, cord, appendage, tentacle, finger, etc.)

which in itself permits the inclusion of air into the incision, to be in fluid communication with another

fluid absorbent material (e.g., a dressing, bandage, etc. and also comprising any natural or synthetic

material, such but not limited to cotton, Teflon, nylon, packing material, etc.) that is positioned

external of the patient and over top of the incision or wound; and maintaining said at least one fluid

absorbing material and said another fluid absorbent material within and top of the incision

or wound respectively, for approximately 1-3 days for conveying fluid out of the incision or wound and

into the another fluid absorbent material. Because of the communication between the (e.g., strip, loop,

tab, cord, appendage, tentacle, finger, etc.) and the outer dressing, the (e.g., strip, loop, tab, cord,

appendage, tentacle, finger, etc.) cannot be accidentally left inside the patient.

"A wound healing device for applying within an incision or wound (e.g., open or closed) is disclosed.

The woundhealing device comprises: at least one fluid absorbent material (e.g., any natural or

synthetic material, such but not limited to: cotton, Teflon, nylon, packing material, etc.) formed into a

strand (e.g., strip, loop, tab, cord, appendage, tentacle, finger, etc.) having a first end that is

positioned within the wound or incision in the subcutaneous skin layer and wherein the strand further

comprises a second free end that protrudes out of the wound or incision.

"A method for wound healing that greatly reduces the chances for infection of an incision

or wound (e.g., open or closed) of a patient is disclosed. The method comprises: forming at least one

strand of a fluid absorbing material (e.g., any natural or synthetic material, such but not limited to

cotton, Teflon, nylon, packing material, etc.); inserting a first end of said at least one strand (e.g., strip,

loop, tab, cord, appendage, tentacle, finger, etc.) inside the incision orwound; positioning a second free

end of said at least one strand to be positioned external of the patient; and maintaining said first end

of said at least one strand within the incision or wound for approximately 1-3 days for conveying fluid

out of the incision or wound and into said strand. BRIEF DESCRIPTION OF SEVERAL VIEWS OF THE

DRAWINGS

"Many aspects of the present disclosure can be better understood with reference to the following

drawings. The components in the drawings are not necessarily to scale, emphasis instead being placed

upon clearly illustrating the principles of the present disclosure. Moreover, in the drawings, like

reference numerals designate corresponding parts throughout the several views.

"FIG. 1A is bottom view of the wound healing device of the present invention;

Page 6: Infection Prevention

"FIG. 1B is a side view of the wound healing device of the present invention;

"FIG. 1C is top view of the wound healing device;

"FIG. 2A is a functional diagram of the wound healing device in place in the closed incision

or wound (e.g., in a patient's abdominal wall);

"FIG. 2B is a functional diagram of the closed incision following the removal of the wound healing

device, showing the formation of type of fistulae in the subcutaneous tissue;

"FIG. 3A is a second more simplified embodiment of the wound healing device;

"FIG. 3B is bottom view of the second embodiment;

"FIG. 3C is a top view of the second embodiment;

"FIGS. 4A-4M depict a surgeon or other healthcare technician applying the wound healing device of the

present invention;

"FIG. 5 depicts a third embodiment of the present invention which uses a continuous loop for the

absorbent member that is disposed in the wound;

"FIG. 6 depicts a fourth embodiment that uses a packing strip for the dressing and to which the

absorbent members are coupled;

"FIG. 7 depicts a fifth embodiment that uses a packing strip for the dressing and to which a continuous

loop absorbent member is coupled;

"FIG. 8 depicts a sixth embodiment of the present invention that uses extendable absorbent members

fed from respective dispensers on or from within the dressing;

"FIG. 9 depicts a seventh embodiment of the present invention that also uses extendable absorbent

members that have extensions in the form of loops that pass through the present invention;

"FIG. 9A depicts a variation of the seventh embodiment of the present invention that also uses

extendable absorbent members that have extensions in the form of loops that are positioned within

the bandage portion of the present invention;

Page 7: Infection Prevention

"FIG. 10 depicts an eighth embodiment of the present invention that also uses extendable absorbent

members wherein the extensions are formed from excess material formed into loops on the absorbent

members;

"FIG. 11 depicts a ninth embodiment of the present invention wherein the absorbent member

comprises foldable component that can be expanded into the wound once the absorbent member is

passed into the closed incision;

"FIG. 12 depicts a tenth embodiment of the present invention wherein the absorbent members are not

in direct contact with the dressing but wherein fluids absorbed into the absorbent members can jump

or leap into the dressing;

"FIG. 13 depicts an eleventh embodiment of the present invention wherein the absorbent members are

positioned within the wound without any coupling to a dressing and to which at a later stage a

dressing may or may not be placed into contact with the portion of the absorbent members that

extends out of the wound;

"FIG. 14 is a functional diagram of the wound healing device in place in an open incision

or wound (e.g., in a patient's abdominal wall);

"FIG. 15 is a plan view of the dressing of another variation of the wound healing device that includes a

cutaway along its edge to accommodate an obstruction, such as a stoma, closely adjacent the incision

or wound; and

"FIG. 15A is a plan view of a further embodiment of the wound healing device that includes an opening

in the dressing that permits an obstruction to pass through the dressing to permit the dressing to

make sufficient contact with the skin when the incision or wound is closely adjacent the obstruction."

URL and more information on this patent application, see: Fulmes, Mychailo; Turkevych, Ihor;

McGough, Michael. Apparatus & Method for Wound Infection Prevention. Filed February 28, 2014 and

posted September 18, 2014. Patent URL: http://appft.uspto.gov/netacgi/nph-Parser?

Sect1=PTO2&Sect2=HITOFF&u=%2Fnetahtml%2FPTO%2Fsearch-

adv.html&r=2031&p=41&f=G&l=50&d=PG01&S1=20140911.PD.&OS=PD/20140911&RS=PD/

20140911

Keywords for this news article include: Surgery, Hospital, Medical Devices, Life Sciences Llc.

Page 8: Infection Prevention

Our reports deliver fact-based news of research and discoveries from around the world. Copyright

2014, NewsRx LLC

Word count: 1979

Copyright 2014, NewsRx LLC

Indexing (details)Cite

People

McGough, Michael

Title

Life Sciences, Llc; "Apparatus & Method for Wound Infection Prevention" in Patent Application Approval

Process

Publication title

Physician Business Week

First page

591

Publication year

2014

Publication date

Sep 30, 2014

Publisher

NewsRx

Place of publication

Atlanta

Country of publication

United States

Publication subject

Medical Sciences

ISSN

1552907X

Source type

Trade Journals

Language of publication

Page 9: Infection Prevention

English

Document type

Editor's Choice

ProQuest document ID

1564738541

Document URL

http://search.proquest.com.ezaccess.library.uitm.edu.my/docview/1564738541?accountid=42518

Copyright

Copyright 2014, NewsRx LLC

Last updated

2014-09-25

Database

ABI/INFORM Complete

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Page 10: Infection Prevention