Wednesday, August 23, 2017

Ethicon launches ProxiSure Suturing Device, improving precision in Minimal Invasive Surgery

Ethicon, part of the Johnson & Johnson Medical Devices Companies, announced today the U.S. launch of the ProxiSure™ Suturing Device, an advanced laparoscopic suturing device armed with Ethicon endomechanical, suture and curved needle technologies.

ProxiSure Suturing Device boasts wrist-like maneuverability and curved needle suitable for operating in tight spaces giving surgeons confidence similar to open surgeries. The suturing precision and ease is achieved because surgeons can reach the desired angle, control bites and and secure knots, with having maximum control of the needle during suturing and knot tying all along.

Dr. Niels-Derrek Schmitz, Franchise Medical Director for Ethicon said, "With the patient's health at the forefront of our thinking, we aimed to introduce a suturing device that will help reduce the margin of error in minimally-invasive surgery. Surgeons will now be able to have the same confidence in laparoscopic suturing that they have always had with traditional procedures using Ethicon products."

"Versatility is the key," said Dr. Schmitz. "ProxiSure enables surgeons to do a wide range of tasks in the OR while maintaining an immensely user-friendly configuration." 

ProxiSure Suturing Device is suitable for use in gynecological procedures, bariatric, general and colorectal surgeries, enabling the surgeon to suture a variety of tissue layers, including flat surfaces.

                                    PROXISURE™ Suturing Device In-Service

Media Courtesy: Ethicon.

Tuesday, August 22, 2017

Johnson & Johnson to pay $417 million to a ovarian cancer patient: a blockbuster verdict by Jury

In a landmark decision, a jury has ordered Johnson & Johnson (J&J) to pay $417m (£323m) to a woman who claimed she developed ovarian cancer after using the company’s talc-based products such as Johnson’s Baby Powder for feminine hygiene.

The verdict was given in favor of California resident Eva Echeverria,who claimed that she developed terminal cancer after decades of use of J&J’s products.

This is the largest payout yet with J&J facing thousands of lawsuits (4800) for failure to warn the consumer about cancer risk of its talc based products.

“We are grateful for the jury’s verdict on this matter and that Eva Echeverria was able to have her day in court,” said Mark Robinson, her lawyer, in a statement.

Her lawyers argued that the company continued to market and encourage women to use its talc based products, despite aware of its carcinogenic potential.

Earlier, a Missouri jury has awarded $72 million to the family of an Alabama woman who died from ovarian cancer in October 2015.

Despite being named as baby powder, it is used by millions of adults in sensitive area to prevent  chafing or promote dryness.

In its natural form talc contains asbestos, a proven carcinogenic since decades.American Cancer Society states,” When talking about whether or not talcum powder is linked to cancer, it is important to distinguish between talc that contains asbestos and talc that is asbestos-free. Talc that has asbestos is generally accepted as being able to cause cancer if it is inhaled. This type of talc is not used in modern consumer products. The evidence about asbestos-free talc, which is still widely used, is less clear.”

It is postulated that if talc or a product containing talc is applied to your genital area in any way (whether it’s applied directly — what’s called perineal talc use —  or whether it makes its way there via pads, condoms, etc.), the powder particles might be able to travel from your vagina all the way up to your ovaries.

This may set off inflammation, which is believed to play an important role in etiology for ovarian cancer.

Many studies have looked into possible link between talc use and ovarian cancer, but the findings are equivocal. A 2003 meta-analysis of 16 studies (11,933 patients) found a link between talc use and ovarian cancer while a 2014 study of 61,576 women did not find the same link.

Meanwhile J&J said, “We will appeal today’s verdict because we are guided by the science, which supports the safety of Johnson’s baby powder.”

So, the bottom line is we still do not have sufficient evidence to prove causation. FDA states that, “There is not sufficient evidence to prove a possible connection.” However, after a flurry of recent lawsuits The U.S. FDA Office of Women's Health has agreed to fund a study investigating the possible link between cosmetic talc use and ovarian cancer.

A posting on the FDA's website notes that while women are commonly known to use products containing talc for hygiene and cosmetic purposes, talc's effects on the tissues that make up the female genital system have not been adequately investigated.

Till causation is proved, the consumers are advised to play it safe and can use talc free powders. A lot of companies make talc-free baby powder out of cornstarch, including Johnson & Johnson.

Monday, August 21, 2017

Are you dense? What every woman and her healthcare provider needs to know.

courtesy: Are you dense

Nearly 20 plus years of research have provided sufficient evidence to link dense breast tissue and increased risk of missing cancer diagnosis by screening mammography. As the breast density increases, the reliability of mammogram as a screening tool for picking up breast malignancy decreases.

What is meant by “being dense”? Breast density does not correlate with physically palpated firmness of breast, it is a radiologic finding and cannot be predicted without obtaining a mammogram. 

Mammographic breast density is defined as the relative amount of radio-opaque (white) elements to radiolucent (black) fat on the image. Increase in the proportion of radio-opaque elements leads to greater mammographic breast density.

Radiologists find it difficult to distinguish between tumor and normal dense tissue, both of which appear white on a mammogram.

In fact, mammography will only detect 30% cancer in dense breasts and 80% in non-dense breasts.
Nearly 40% of women have dense breast, which means that only using mammography as a screening tool puts this population at high risk of missing the diagnosis, delayed diagnosis or diagnosis at very late stage of disease. A recent search of PubMed revealed nearly 3,027 studies on masking risk of dense breast tissue.

Increased density of breast is a casual as well as masking risk factor for breast cancer. According to the American Cancer Society, having heterogeneously or extremely dense breast tissue puts you at risk of breast cancer that is equivalent having one first-degree relative with breast cancer. (2.1 to 4 times the normal risk)

Also, women with dense breast are put at increased risk of developing contralateral breast cancer and interval cancer (cancer detected within 12 months of a normal mammogram)

A recent Breast Cancer Surveillance Consortium study noted that breast density exceeds all other risk factors like obesity, family history and delayed childbirth.

About 28 states in USA have passed law regarding the mandatory reporting of breast density and the necessary follow up thereafter, after women have a screening mammogram.

So, is there a standard protocol for supplemental screening if a woman is diagnosed of having dense breast on screening mammogram? No, unfortunately not, the medical community has not agreed on a protocol regarding supplemental screening for women with dense breasts.

In a position statement, the ACOG, identifies dense breast as a moderate risk factor but does not support routine use of adjunct screening modalities in an average risk woman with dense breast. The American Cancer Society urges the patients with dense breast to talk to healthcare providers about additional screening modalities and advises an MRI along with her yearly mammogram in a high-risk group.

The American College of Radiology identifies breast density as a controversial risk factor for breast cancer with no consensus that it confers sufficient risk to warrant supplemental screening.

At this time, it is highly suggested that patient should initiate a dialogue with her physician, regarding the protocol to be followed after the diagnosis of dense breast. Each patient should be individually evaluated about her risk of breast cancer based on her genetics, family history and other risk factors.

One suggested approach based on a paper presented by Lee C. at Society of Breast Imaging/American College of Radiology Breast Imaging Symposium; April 26, 2015; Orlando, FL is to use tomosynthesis for all levels of risk, supplemental whole-breast ultrasonography for women with average risk, and supplemental magnetic resonance imaging for women with intermediate and high risk

For women who are at high risk and also have a contraindication to magnetic resonance imaging, whole breast ultrasonography or molecular breast imaging, if available, may be an appropriate alternative.


The current options available in addition to screening mammography are Tomosynthesis or 3D mammography, Ultrasound, Magnetic Resonance Imaging (MRI), Molecular Breast Imaging (MBI) or Breast Specific Gamma Imaging (BSGI) and Contrast Enhanced Spectral Mammography (CESM)

Nancy M. Cappello, Ph.D. has founded Are You Dense, Inc., and Are You Dense Advocacy, Inc., to educate women and general public about the challenges women with dense breast face regarding the screening tools for detecting early breast cancer.

Classification of Breast Density: American College of  Radiology. 

click to enlarge

Sunday, August 20, 2017

Clinical review: Updates on Menopause

Here is a roundup of the latest research on Menoapuse.

In this article:

Early menopause ups the risk of developing type 2 diabetes
Women who have an early natural menopause have 2.5 times the risk of developing type 2 diabetes as compared to women who have normal menopause reports the results of a large population based study published online July 18, 2017 in Journal Diabetologia.

Oophorectomy during premenopausal hysterectomy: Evaluating the prevalence
Nearly 1 in 3 women undergo oophorectomy during premenopausal hysterectomy in absence of appropriate indication, reports a study published ahead of print May 8, 2017 in North American Menopausal Society (NAMS) journal Menopause.

Loss of estrogen in postmenopausal women puts them at high risk for lumbar disc degeneration.
Declining estrogen levels during perimenopausal and menopausal years is associated with severe lumbar disc degeneration reports a study published online June 12, 2017 in journal Menopause, the journal of The North American Menopause Society (NAMS).

ACP updates guideline for treating Osteoporosis.
According to International Osteoporotic Foundation (IOF), 1 in 3 women over age 50 will experience osteoporotic fractures and nearly 200 million women suffer from osteoporosis worldwide.

Polycystic ovarian syndrome increases the risk of subsequent early ovarian aging later in life.
Women with polycystic ovarian syndrome (PCOS) have 8.64-fold increase in risk of developing premature ovarian failure as compared to women who did not have PCOS according to a population based study in forthcoming issue of Journal Menopause. Metformin was found to be effective in reducing such risk.

New natural (bioidentical) 17ß-estradiol-progesterone combination available as single soft gel capsules effective in treating postmenopausal symptoms: News from ENDO17
An innovative, investigational combination of 17ß-estradiol and progesterone in a single, oral softgel, was found effective for the treatment of moderate to severe vasomotor symptoms (VMS) due to menopause. The results of the study were presented at the ENDO 2017, the annual meeting of the Endocrine Society in Orlando, Florida, April 1-4.
New class of drug effective in targeting menopausal symptoms: News from Endocrine Conference 2017.
A new class of drug Neurokinin 3 (NK3) receptor antagonists is highly effective and low risk alternative to hormone replacement therapy(HRT) for treatment of menopausal hot flashes according to a study presented at the ENDO 2017, The endocrine society annual meeting from April 1–4, 2017, in Orlando, FL.

Menarche ≤11 years and Nulliparity is a risk factor for Premature and Early Menopause.
Women who had their first period at or before the age of 11 are at increased risk for premature and early menopause and the risk is further amplified if the woman is nulliparous according to a large observational study published on January 25, 2017 in Oxford Journal of Human Reproduction.

Saturday, August 19, 2017

North American Menopause Society (NAMS) video series about important midlife health topics: Midlife Immunizations

The North American Menopause Society (NAMS) has started comprehensive video series for clinicians about important midlife health topics. All the interviews in the series are hosted by NAMS Board of Trustees Member and President Dr. Marla Shapiro, a Canadian physician, who led this exciting initiative.

In this latest video, Midlife Immunizations, Dr. Shapiro interviews Dr. Lisa Larkin, an internist, President of Lisa Larkin MD and Associates, and Director of Women’s Corporate Health at TriHealth in Cincinnati, Ohio.

 Immunizations are critically important to health and wellness of all humane beings, especially midlife women who are often under vaccinated. Women are busy taking care of family members and often neglect their own health, missing to talk with the healthcare provider about their own vaccinations.

This video talk lists why women should take care of their immunization and why these shots play an important role in preventive medicine not only for them but for entire family.

Here is the video about midlife immunizations and why they are important to our health. 

Friday, August 18, 2017

External Cephalic Version for breech presenting fetus does not hike the cesarean section rates.

Women who had a successful External Cephalic Version (ECV) are not at increased risk of cesarean section as compared to women who had Spontaneous Cephalic Version (SCV) says the results of a study published ahead of print on August 2, 2017 in Journal of Obstetrics and Gynecology Canada. 
This is first study conducted to compare the outcome between spontaneous and external version in breech presenting fetuses.

It is estimated that term fetal malpresentation occurs in about 3% of pregnancies—and is a common indication for cesarean. External Cephalic version is an important tool to reduce the rate of cesarean births in breech presentation.

This secondary analysis of Early External Cephalic Version Trial data identified 931 women who had breech presenting fetuses between 34-36 weeks of pregnancy, but cephalic presentation at term.
Out of these study subjects, 557 women have undergone successful ECV while in 374 women the fetus reverted spontaneously.

Obstetric outcomes between the two groups were comparable: 96 women in ECV arm had Cesarean section as compared to 76 in the SCV group. (adjusted OR [aOR] 0.89; 95% CI 0.63-1.26); 393 had vaginal delivery in ECV arm vs 268 in SCV arm. (aOR 0.92; 95% CI 0.68-1.24).

Women in the ECV had 45% increased odds of undergoing instrumental intervention as compared to women in SCV group. (aOR 1.55; 95% CI 0.96-2.50).

Multiparous women with ECV were half as likely to require a cesarean section as compared to women with spontaneous version or no version at all. ( aOR 0.45; 95% CI 0.26-0.80).

The authors concluded, “Women with a cephalic-presenting fetus at birth as a result of successful ECV are not at greater risk of obstetrical interventions at birth when compared with women with fetuses who spontaneously turn to a cephalic presentation in the third trimester.”

Media Courtesy: American Association of Family Physicians 

Thursday, August 17, 2017

HPV testing vs Pap test in cancer screening: Cochrane Systematic review

A negative HPV test is more reassuring than a negative Pap test, as the cytology screening has a higher chance of being false negative thereby missing some women with precancerous lesions and delaying treatment says the result of a Cochrane Systematic review published ahead of print.

Since decades the usual method of screening for cervical cancer is based on cell cytology, but since the etiological relationship between cervical cancer and HPV infection was confirmed along with advent of HPV testing in 1999, the supremacy of these two tests is debated.

Some physician advice Pap and HPV both, especially for women over 30 years old, who are most at risk of cervical cancer, getting both tests provides the best assurance of finding cervical disease before it becomes cancer.

Younger women (20-30) are advised to get HPV test only if their Pap smear looks "inconclusive" or "borderline.”

This systematic review by Cochrane was aimed at determining efficacy of the two tests in detecting precancerous lesions (CIN 2+ and CIN 3+). Literature search for relevant studies till November 2015 identified about 40 studies amounting to a total of 140,000 women between 20 to 70 years old who underwent cervical cancer screening.

Data analysis identified true positives (TP), false positives (FP), true negatives (TN), and false negatives for each screening test (HPV test and cytology) used in each study.

It was seen that HPV test was more sensitive than conventional Pap test and liquid based test in identifying CIN 2+ and CIN 3+, but less specific than Pap test in detecting precancerous lesion.

Data analysis showed that for every 1000 women screened, around 20 women will have precancerous lesions. If HPV test is used, it will correctly identify 16 of the 20 women to be positive for the lesions (but will miss 4 women who have the lesions). The Pap test will correctly identify 12 of the 20 women (but will miss 8 women).

Similarly, for every 1000 women screened, there will be 980 women who will not have precancerous changes. The HPV test will correctly identify 879 women as disease free (but 101 women will be incorrectly told that they have a lesion). The Pap test will correctly identify 951 women (but 29 will be incorrectly told that they have a lesion).

This high false positive rate of HPV testing will lead to high unnecessary referrals and further tests like colposcopy, biopsy and surgery but at the same time it will also identify 50% more women with precancerous changes as compared to conventional cytology.  

The authors concluded that,” Whilst HPV tests are less likely to miss cases of CIN 2+ and CIN 3+, these tests do lead to more unnecessary referrals. However, a negative HPV test is more reassuring than a negative cytological test, as the cytological test has a greater chance of being falsely negative, which could lead to delays in receiving the appropriate treatment.”

Source: Koliopoulos G, Nyaga VN, Santesso N, Bryant A, Martin-Hirsch PP, Mustafa RA, Schünemann H, Paraskevaidis E, Arbyn M. Cytology versus HPV testing for cervical cancer screening in the general population. Cochrane Database Syst Rev. 2017;8:CD008587. doi: 10.1002/14651858.CD008587.pub2. PMID: 28796882

Access the abstract here.

Wednesday, August 16, 2017

ACOG releases Committee Opinion for Prenatal Corticosteroid Therapy for Fetal Maturation

ACOG releases Committee Opinion for Prenatal Corticosteroid Therapy for Fetal Maturation.

An updated committee opinion from the American College of Obstetricians and Gynecologists (ACOG), published in the August issue of Obstetrics & Gynecology.

Liggins and Howie published their landmark paper in 1972, that showed the benefits of single course of antenatal corticosteroid therapy administered to women at risk for preterm delivery in reducing RDS and mortality in offspring.

Since then countless trials have confirmed these findings and also shown that timely steroid administration reduces rates of intraventricular hemorrhage (IVH) and necrotizing enterocolitis.

An updated ACOG opinion published in October 2016 issue, expanded the use of steroids in women at high risk for late preterm birth (34 0/7 - 36 6/7 weeks).

The current recommendations are:

A single course of corticosteroids is recommended for pregnant women between 24 0/7 weeks and 33 6/7 weeks of gestation who are at risk of preterm delivery within 7 days, irrespective of intact or ruptured membranes and single or multiple gestations.

It could also be given at 23 0/7 weeks of gestation to women at risk of preterm delivery with 7 days based on discussion with family members regarding resuscitation of the newborn.

A decision to administer corticosteroids during the peri viable period (20 0/7 weeks to 25 6/7 weeks of gestation) should always be based on discussions with the patients and family members regarding resuscitation of the newborn.

A single course of betamethasone is recommended for pregnant women at risk of preterm birth between 34 0/7 weeks and 36 6/7 weeks of gestation, provided they have not received a previous course of antenatal corticosteroids.

A single repeat course can be given to women who are less than 34 0/7 weeks of gestation who are at risk of preterm delivery within 7 days, whose previous course was administered more than 14 days earlier and in some clinical scenarios 7 days earlier.

Repeated or serial administration of more than 2 doses is not recommended.

At present, no recommendation can be made for a repeat or rescue dose of corticosteroids in patients with preterm prelabor rupture of membranes (PROM).

ACOG also recommends long term follow up and surveillance of babies who received in utero corticosteroids administration.

It also advocates ongoing development of strategies to support timely administration of corticosteroids to women at risk of delivering with 7 days and avoid overuse in low risk patients.

The committee opinion full text can be accessed here.

Tuesday, August 15, 2017

Finally, a injectable tissue bandage to mend "broken hearts"

The flexible tissue scaffold, shown here emerging from a glass pipette with a tip one millimeter wide

Scientists at University of Toronto have developed an expanding tissue patch that works like a bandage in mending broken hearts. Repairing ischemic heart muscles destroyed by a cardiac event with regenerative stem cells requires an open-heart surgery.

Open-heart surgery is an invasive and risky approach after a heart attack and delivering the regenerative patch through a minimally invasive approach was thought to be impossible.

But now biomedical engineering Professor Milica Radisic (IBBME, ChemE, Toronto General Hospital Research Institute) and her colleagues have developed a technique that lets them use a small needle to inject a repair patch, without the need to open up the chest cavity.

This team is already expert in growing 3D slices of human tissue in laboratory using polymer scaffolds. These tissues are used to test drugs pharmacokinetics in lab.

Professor Milica Radisic says, “If an implant requires open-heart surgery, it’s not going to be widely available to patients,” says Radisic. She says that after a myocardial infarction — a heart attack — the heart’s function is reduced so much that invasive procedures like open-heart surgery usually pose more risks than potential benefits. It’s just too dangerous.”

The researchers have developed a patch that can pass through a narrow needle, and after reaching the target site it still has the memory to spring back to its original shape.

The scaffold is made out of some biodegradable and biocaompatible material that breaks down over time as the stem cells regenerate and form new muscle tissue.

The experiment has already been successful in animal studies and have shown that the patch can improve heart function after myocardial infarction.

The study was Published online 14 August 2017 in Journal of Nature Materials.

 Miles Montgomery, a researcher involved in the study said, “Heart cells are extremely sensitive, so if we can do it with them, we can likely do it with other tissues as well.”

The researchers are working to develop patch for other organs like liver with add-on of growth factor and drugs to be delivered at the site.

It’s a long way before clinical trials are completed and the treatment is available for patients but, a cure for mending “broken hearts” is on the way.

Here is the video to explain how injectable tissue patch could help repair damaged organs.

Trak fertility tracker, a breakthrough in at home sperm count testing launched.

SandstoneDiagnostics, a company based at Livermore, CA has launched Trak, a revolutionary new approach to male fertility that helps men test, learn and try to improve their sperm count over time. 

Many couples simply delay fertility treatment because the male partner is not comfortable in getting a semen analysis in the laboratory. Well, Trak not only measures sperm count based on current world health organization (WHO) guidelines and clinical research, from the comfort and privacy of your home, but it also offers you advice to improve the reproductive health.

This easy to use, first FDA cleared Trak engine uses centrifugal separation technique to isolate and quantify sperm count. The results are displayed like a thermometer reading as Low, Moderate or Optimal for conception.

click to enlarge

The kit that is available on Amazon, costs 199 $ for four testing sets. It is mailed to your doorsteps in discrete package and each set includes a collection cup, a dropper, a stick that the company calls a prop, and two seals.

Simultaneously, set up the Trak app on your smart phone and have to feed in answers to simple life style questions. The app will give you a basic score and combined with the sperm test results, you get information to make changes in your life style to improve your low results.

Many other at home sperm count testing devices are available but the combination of centrifugal system and app to improve reproductive health gives it an edge over other devices. 

Here is a video about how the test works.

Media Courtesy:

Monday, August 14, 2017

Society for Maternal-Fetal Medicine (SMFM) issues guidelines for HCV in pregnancy

The Society for Maternal-Fetal Medicine (SMFM) has issued guidelines for screening and management of Hepatitis C infection in pregnancy.  

The guidelines were published ahead of print in American Journal of Obstetrics and Gynecology.

It is estimated that on average nearly 1-2.5% of pregnant women in US are infected with the virus and the risk of vertical transmission is 5%.

The recommendations are:

1) All women who are at increased risk for Hepatitis C should get tested for anti-HCV antibodies at their first prenatal visit. If the risk persists till later in pregnancy or new risk factor arise, the screening should be repeated again. (GRADE 1B)

According to American Liver Foundation the risk of Hepatitis C is increased if:
  • Shared needles to inject drugs or straws to inhale them
  • Had tattoos or body piercings in an unclean environment using unsterile equipment
  • Worked in a place where you came in contact with infected blood or needles, for example, healthcare workers
  • Received a blood transfusion or organ transplant before July 1992
  • Received a blood product for clotting problems made before 1987
  • Needed to have your blood filtered by a machine (hemodialysis) for a long period of time because your kidneys weren’t working
  • Were born to a mother with HCV
  • Had unprotected sex with multiple partners
  • Have or had a sexually transmitted disease
  • Have HIV
2) All HCV positive pregnant women should be screened for other sexually transmitted diseases (STDs) including HIV, syphilis, gonorrhea, chlamydia, and hepatitis B virus (HBV). (GRADE 1B)

3) All patients with HCV, including pregnant women should be advised to refrain from consuming alcohol. (Best Practice)

4) Direct-acting antiviral medications (DAA) are not to be used in pregnancy, except in settings of clinical trials. The treatment should be initiated after the delivery of the patient in the postpartum period. (Grade 1C).

5) If invasive prenatal testing is requested than amniocentesis is preferred over chorionic villus sampling (CVS) because of limited data on the risk of vertical transmission for CVS over amniocentesis. (Grade 2C).

 6) HCV infection solely is not an indication for Cesarean section in absence of other obstetric indications. (GRADE 1B)

7) Internal fetal monitoring, prolonged rupture of membranes, and episiotomy should be avoided during labor in HCV+ women (Grade 1B).

8) Positive HCV status is not a contraindication for breast feeding. (Grade 1A).

Saturday, August 12, 2017

Clinical review: Updates on Cesarean Section

Here is a roundup of the latest research on Cesarean Section.

In this article:

Subcuticular skin closure after cesarean delivery with poliglecaprone 25 suture IMONOCRYL) decreases the rate of cesarean wound complications by 39% as compared with polyglactin 910 suture (Coated VICRYL) says the result of randomized control trial published ahead of print in Journal Obstetrics and Gynecology.

A simple and inexpensive intervention of vaginal cleaning with an antiseptic solution before cesarean delivery brings down the rate of endometritis note the results of a Systematic Review and Meta-analysis published August 4 in Journal of Obstetrics and Gynecology.

Double layer closure of uterus during previous cesarean section results in thicker third-trimester lower uterine segment and decreases rate of uterine rupture by 3 to 5fold during trial of labor after cesarean (TOLAC) and vaginal birth after cesarean reports results of multicenter prospective cohort study published in July issue of Journal obstetrics and gynecology.

Chlorhexidine-Alcohol is not superior to Povidone-Iodine in reducing the rate of surgical site infection in Cesarean section reports the results of Chlorhexidine-Alcohol Versus Povidone-Iodine for Cesarean Antisepsis (CAPICA) Trial published ahead of print in American Journal of Obstetrics and Gynecology.

Novel Cesarean Section Scalpel that increases fetal safety during surgery unveiled.

A C-section rate of approximately 19 percent seems to be ideal for the health of both women and newborns.

Friday, August 11, 2017

Use of Monocryl for subcutaneous skin closure minimizes wound complications in cesarean sections


Subcuticular skin closure after cesarean delivery with poliglecaprone 25 suture IMONOCRYL) decreases the rate of cesarean wound complications by 39% as compared with polyglactin 910 suture (Coated VICRYL) says the result of randomized control trial published ahead of print in Journal Obstetrics and Gynecology.

Monocryl is monofilament, absorbable suture which dissolves slowly and loses strength while Vicryl is braided, absorbable suture that dissolves quickly but maintain strengths.

The type of skin suture and rate of wound infection after cesarean section has not been widely studied. In this study, the researchers compared the two sutures in term of subsequent wound complication rates (SSI, hematoma, seroma, wound separation) after a cesarean section through a Pfannenstiel skin incision followed by subcuticular closure.

This single center RCT conducted at Montefiore Medical Center, New York recruited about 520 women over a course of 1.25 years. About 263 women were randomized to receive the wound closure with monocryl while in 209 women the wound was closed with vicryl.

The groups were similar in terms of demographics, medical comorbidities and perioperative characteristics. They were followed up for a period of 30 days for wound gaping of > 1 cm in length, hematoma or seroma and surgical site infections as per Centers for Disease Control and Prevention criteria’s.

Use of monocryl was associated with significant less infection as compared to vicryl (8.8% compared with 14.4% (relative risk 0.61, 95% CI 0.37-0.99; P=.04).

The researchers concluded that,” Closure of the skin after cesarean delivery with poliglecaprone 25 suture decreases the rate of wound complications compared with polyglactin 910 suture.”

Thursday, August 10, 2017

Vaginal cleaning before cesarean delivery significantly reduces infection: A Systematic Review and Meta-analysis.

A simple and inexpensive intervention of vaginal cleaning with an antiseptic solution before cesarean delivery brings down the rate of endometritis note the results of a Systematic Review and Meta-analysis published August 4 in Journal of Obstetrics and Gynecology.

The effect was significantly more in patients in labor or with ruptured membranes at the time of the procedure.

Claudia Caissutti, MD, from the Department of Experimental Clinical and Medical Science, Clinic of Obstetrics and Gynecology, University of Udine, Italy, and colleagues searched MEDLINE, Ovid, EMBASE, Scopus,, and Cochrane Library from their inception to January 2017.

They included randomized trials comparing vaginal cleaning with any antiseptic against placebo or no cleaning at all. The final data for review came from 16 RCTs, with a total of 4,837 women in whom vaginal preparation was done immediately before the start of cesarean section.

Most of the trials used povidone–iodine (n = 11) as the cleaning agent, while rest used chlorhexidine diacetate solution n = 3) , metronidazole vaginal gel prep ( n =1), and Cetrimide ( n =1) .

The observed incidence of endometritis in women who received preoperative vaginal cleansing was nearly 50% less as compared to women with placebo or no cleaning (4.5% vs 8.7%; relative risk [RR], 0.52; 95% confidence interval [CI], 0.37 - 0.72). These group also had significantly lower incidence of postoperative fever (9.4% compared with 14.9%; RR, 0.65).

No significant difference was observed in postoperative wound infection among the groups.

In a separate planned subgroup analysis, the observed difference in rates of endometritis was only seen in women who were in active labor and for patients with rupture of membranes. Four trials stratified the data according to women were in labor or not and three trials looked into women with and without ruptured membranes.

When the data was stratified according to type of cleaning agent and prophylactic antibiotics, the results were in according to the overall analysis.

Women who received prophylactic antibiotics had a 67% decrease in endometritis incidence. The authors opined, "Surgical prophylaxis with intravenous antibiotics before cesarean delivery has been clearly demonstrated as beneficial in reducing postoperative infection morbidity, Thus, it is the standard of care and these findings could translate to current practice."

The results of study have confirmed the findings of earlier Cochrane database systematic review published in 2013.

Data is needed to assess the effect of vaginal cleaning in women not in labor and without ruptured membranes.

The authors concluded that, “Vaginal cleansing immediately before cesarean delivery in women in labor and in women with ruptured membranes reduces the risk of postoperative endometritis. We recommend preoperative vaginal preparation before cesarean delivery in these women with sponge stick preparation of povidone-iodine 10% for at least 30 seconds.”

Wednesday, August 9, 2017

Now Ovarian Tissue paper to support normal hormonal production: Breakthrough in Regenerative Medicine

An accidental Spill has sparked a breakthrough in the field of regenerative medidicne. Scientists and engineers at the Northwestern Medicine have invented a range of bioactive “tissue papers” made from organs combined with a polymer to make them so pliable.

These new “tissue papers” are so thin and pliable that they can be folded into an origami bird. Their clinical application is for wound healing and aid in natural hormone production in young cancer patients.

The desired organ is first broken up into tiny pieces, decellularized and the resulting sticky semifluid matter, is dried. After it dehydrates completely it is made into a powder and combined with polymer to form thin sheets.

The study was published in Journal of Advance Functional Material on August 7, 2017. In the study, animal organs were used to make individual papers made from ovarian, uterine, kidney, liver, muscle or heart proteins. Each tissue paper retained the cellular and biochemical properties of organ it was derived from.

Ramille Shah, the corresponding author for the paper and assistant professor of surgery at the Feinberg School of Medicine and an assistant professor of materials science and engineering at McCormick School of Engineering said in a Northwestern news release , “This new class of biomaterials has potential for tissue engineering and regenerative medicine as well as drug discovery and therapeutics. It’s versatile and surgically friendly.”

The tissue paper will provide the necessary framework and cell signaling needed to help regenerate tissue to prevent scarring and accelerate healing.

In lab experiment, the tissue paper made from bovine ovary was used to grow follicles that produced eggs and hormones for proper function and maturation.

Teresa Woodruff, coauthor and director of the Oncofertility Consortium and the Thomas J. Watkins Memorial Professor of Obstetrics and Gynecology at Feinberg said, “This could provide another option to restore normal hormone function to young cancer patients who often lose their hormone function as a result of chemotherapy and radiation.”

Menopausal women or women with cancers could benefit by hormones produced by such tissue papers implanted in the body.

In addition, the tissue paper supported the growth of human stem cells, creating multiple clinical application in future of regenerative medicine.

The so called “tissue papers” look and behave like normal papers, they can be folded or stacked like office papers. In vivo, when wet, they retain the mechanical strength and can be rolled, folded or sutured to tissue.

The organ tissue paper was accidentally discovered when Adam Jakus working on making  3-D printable ovary ink, which spilled and dried up into a dry sheet.

“When I tried to pick it up, it felt strong,” Jakus said. “I knew right then I could make large amounts of bioactive materials from other organs. The light bulb went on in my head. I could do this with other organs.”

One day it could be used to repair muscles while doing surgery or as a sophisticated wound dressing after surgery.

Here’s a video from Northwestern showing off the new tissue papers.

                              Origami Organs' can potentially regenerate tissues


Media courtesy: Northwestern University.