39 Clinical Trials for Various Conditions
The purpose of this study is to see whether chlorhexidine is superior to povidine-iodine vaginal antisepsis at reducing bacteria colony counts in pregnant women by comparing three groups: vaginal washing with chlorhexidine-alcohol, vaginal washing with povidine-iodine, and vaginal washing with saline alone.
This investigator-initiated, open-label, randomized controlled trial will explore the effects of two treatment arms, comparing standard treatment with normal saline against Irrisept, a jet lavage solution containing a low concentration of Chlorhexidine Gluconate (CHG) at 0.05% in 99.95% sterile water for irrigation. The study aims to evaluate the impact on postoperative wound healing in patients who have undergone cesarean delivery.
This will be a single-center randomized control trial comparing the efficacy of two different formulations of Chlorhexidine surgical skin preparation in preventing cesarean section wound infections. Participants will be randomized to either 4% Chlorhexidine Gluconate aqueous solution (CHG) or 2% Chlorhexidine with isopropyl alcohol (CHG-IPA) 70% to examine the risk of infectious morbidity in those undergoing cesarean delivery. There will also be a cost-effectiveness analysis of the two preoperative skin preparations.
To assess patient centered outcomes of the Medela INVIA Motion prophylactic NPWT system at cesarean delivery.
The purpose of this study is to determine the feasibility of collecting amniotic fluid at delivery that will be immediately processed and then applied as a spray to the various layers of cesarean wound closure.
Cesarean deliveries are the most common surgical procedure performed in the United States. A significant decrease in cesarean delivery associated maternal morbidity has been achieved with preoperative prophylactic single-dose cephalosporin, widely used before skin incision. Also, on laboring patients and/or with rupture of membranes, several studies suggest that adding azithromycin to standard cephalosporin prophylaxis is cost-effective and reduces overall rates of endometritis, wound infection, readmission, use of antibiotics and serious maternal events. Azithromycin has effective coverage against Ureaplasma, associated with increased rates of endometritis. Although two-drug regimen has been suggested for laboring and/or patients that undergo cesarean delivery, no studies have investigated the potential benefits of two-drug regimen in non-laboring patients.
This study is a single center, randomized controlled trial investigating the use of an abdominal closure bundle to reduce surgical site infection in patients undergoing cesarean section. The abdominal closure bundle consists of surgeon repeat scrub, changing gown and gloves, as well as usage of new instruments for closure of fascia, subcutaneous tissue, and skin. Patients will be randomized to either abdominal closure bundle or normal operative procedure. Primary outcome is surgical site infection within 30 days of procedure.
Abdominal closure with antibacterial-coated sutures has been shown to reduce wound infections after a number of surgical procedures, but none of the previous trials included cesarean delivery. Our objective is to determine whether use of antibacterial-coated sutures reduces surgical site infection (SSI) after cesarean delivery.
The purpose of this study will be to assess whether forced air warming decreases the rate of surgical site infections following cesarean section.
Previous studies have demonstrated that patients who undergo surgery while they under general anesthesia have fewer wound infections if they receive higher concentrations of oxygen but this has never been studied in women who are undergoing cesarean section. We plan to randomize women who are undergoing cesarean to receive either standard of care oxygen flow through a nasal cannula during their cesarean section only or a higher concentration of oxygen than they would typically receive through a face mask. Women will receive this therapy during their cesarean and for 2 hours afterwards. We will follow them after their surgery for evidence of infection either in their wound or their uterus.
Postpartum infection if a major cause of maternal morbidity and mortality and surgical site infections are some of the common complications following cesarean section. This study aims to determine the effect of Steri3X on the incidence of cesarean section SSI at Regional One Hospital.
It is the purpose of this study to evaluate the relationship between a low transverse, vertical midline, and supra-panicular high transverse skin incisions and the rate of wound complications in women with a BMI of 40 or greater undergoing a cesarean section for delivery. So far, the choice of incision for the morbidly obese is based only on case reports. No randomized controlled trials have been done up to date comparing these methods. It is our hope that a high transverse incision will have all of the benefits of a low transverse skin incision, with the added benefit of better exposure offered by a vertical midline incision, without the added increased risk of subjecting the woman to a vertical hysterotomy.
The objective of this study is to determine if the use of chlorhexidine gluconate cloths prior to cesarean section reduce the rate of infectious morbidity (i.e. surgical site infections, endometritis). The study will be offered to women who present for a scheduled primary or repeat cesarean section at Mount Sinai Medical Center. The eligible women will be randomized to use of a 2% chlorhexidine gluconate (CHG) cloth or placebo cloth (a fragrance free cleansing cloth) the night before and the morning of their scheduled procedure. Participants will be blinded to the arm in which they have been assigned. This study intends to show that the use of 2% CHG cloths prior to cesarean section will reduce the rate of surgical site infections.
The purpose of this study is to determine whether an increased prophylactic dose (3 grams) of cefazolin at the time of cesarean delivery has superior coverage in adipose tissue than the current established dosing of 2 grams. The tissue and serum concentration values, when using an increased prophylactic dose, can then be compared to our pilot study assays in hopes of determining an optimal dosing for the obese and morbidly obese populations undergoing cesarean delivery. A previous study performed at University of California, Irvine (UCI) and Long Beach Memorial Medical Center/Miller Children's Hospital (LBMMC) showed that the standard dose of antibiotics (2 grams of cefazolin) did not provide adequate coverage for all organisms in the obese and extremely obese populations. The purpose of this research study is to evaluate whether in increased dose of antibiotics given before cesarean delivery (3 grams of cefazolin) will reach adequate levels in adipose (fat cells underneath the skin) and serum (blood) samples. In addition, researchers hope to evaluate if/how the mother's weight has an effect on the levels of antibiotics in the tissues (a group of similar cells). This follow up study (prior study HS# 2009-7015 at UCI) will enroll obese (Body Mass Index (BMI) of 30-40) and morbidly obese (BMI \>40) women to receive an increased dose of prophylactic cefazolin at time of scheduled cesarean delivery at both UCI and LBMMC. Researchers hope to enroll a total of 35 women overall.
Surgical site infections (SSI) are the second most common cause of nosocomial infections accounting for 15% of all nosocomial infections among hospitalized patients and 38% of nosocomial infections in surgical patients. In obstetric patients, infectious morbidity (i.e. SSI, endometritis) occurs in 5-10% of cesarean sections, which is 5-fold higher than vaginal deliveries. Additionally, infectious morbidity is thought to be highest in those patients who have cesarean sections after undergoing labor. Chlorhexidine, a chemical antiseptic effective on gram positive and gram negative bacteria, reduces skin microflora/colonization but it is not clear if it decreases the risk of SSI. Historically, chlorhexidine has been studied and used in orthopedic and cardiac implant surgeries. Research on the use of chlorhexidine for SSI prevention in cesarean sections is limited. This study intends to evaluate the effectiveness of use of both chlorhexidine gluconate (CHG) wipe and vaginal scrub in reducing SSI in patients undergoing cesarean section that have previously been laboring. Patients will be randomized to one of two groups: wash with both a pre-operative CHG cloth prior to surgery and chlorhexidine gluconate vaginal scrub in addition to standard preoperative scrub as compared to standard preoperative scrub alone.
Effect of Prophylactic Negative Pressure versus Silver Impregnated Silicone Bandage on Cesarean Section Surgical Site Infection Rate
Currently there is no study investigating best skin cleaning patterns prior to cesarean deliveries. As a result, doctors perform skin preparation using random unstudied techniques. Techniques vary from Hospital to Hospital and even within the same institution. The most widely used topical skin preparation is ChloraPrep and the manufacturer has not recommended a specific pattern to be used in order to abdominally prep prior to C-sections. In addition most studies do not examine the effectiveness in the obese population. The manufacture has established a recommended dosage area of 13in x13in per ChloraPrep stick as well as timing from initial preparation until the practice reached its maximum antiseptic benefit. Our current cesarean infection rate is very low, at just 1.6% over the last 12 months (September 2107-2018). This is significantly lower than the average cesarean section infection rate in the United States which is around 7.4% using iodine based preparations. Cesarean deliveries are one of the most common major surgeries performed in the United States, 31.9% of all births are by cesarean section. The risk of infection following a cesarean delivery is nearly 5 times that of a vaginal delivery. However, there is still no study that examines the pattern which ChloraPrep is applied to the abdomen prior to a cesarean delivery in patients with a BMI greater than 30. The pattern of skin preparation appears to be heavily related to physician training and personal bias.
Our goal is to provide data that will give surgeons and hospitals clear recommendations on the use of NPWT for Cesarean section, abdominal hysterectomy and colon surgeries in patients with diabetes and/or obesity. We also want to understand the patient experience with the dressing so that we can provide information that will enable clinicians to remove barriers to NPWT use. Additionally, we are seeking to use automated electronic medical record decision support to identify patients that will benefit most from the NPWT.
The purpose of this study is to test the hypothesis that vaginal cleansing with povidone-iodine solution immediately prior to cesarean delivery reduces postcesarean infectious morbidity.
To study if incisional vacuum-assisted closure can decrease the risk of infection in cesarean section incisions in the obese compared with standard sterile dressing.
Surgical site infections are common and a cause of major morbidity. They are also more common in obese women. Cesarean sections are the most common surgery performed in the United States, therefore pregnant women are being faced with this problem frequently. There is evidence to show that prophylactically administered antibiotics, cefazolin specifically, to obese women prior to cesarean section do not reach adequate concentrations in adipose tissue to prevent infection. The purpose of this study is to evaluate if an increased dose of cefazolin will attain adequate tissue concentration in obese women. Our hypothesis is that three grams of cefazolin given no more than 60 minutes prior to the start of a cesarean section in an obese (Body mass index (BMI) greater than or equal to 30) woman will attain adequate adipose tissue concentration compared to two grams of cefazolin. Subjects will be selected if they are greater than 37 weeks gestation wiht a singleton pregnancy and require a cesarean section for any obstetrical indication. Women will be excluded if they have a suspected infection, have a multiple gestation, or have preexisting diabetes or hypertension with end organ damage. The subjects will be screened both by through the OR schedule as well as through the clinics. They will then be consented and enrolled by the primary investigator. Once enrolled the subjects will be randomized to receive either two grams or three grams of cefazolin as prophylactic antibiotics to be given no more than 60 minutes prior to the start of the surgery. Two adipose tissue samples will be obtained at the time of surgery. The first at the start after skin incision and the second at the end prior to closure of the skin. There will also be a separate IV placed at the start of the procedure from which three blood draws can be collected. These three samples will be obtained at the start of the surgery but after antibiotic administration, at the time of the first adipose collection, and at the time of the second adipose collection. The samples will then be stored at -80 degrees and shipped to David P. Nicolau's lab in Hartford, CT for the tissue and serum analysis. While the subjects are in the hospital recovering from their surgery, a chart review will be performed to determine if there are any infections occuring post-operatively. A telephone survey will be conducted six to eight weeks postpartum again assessing for any infectious complications after the cesarean section.
The purpose of this study is to determine if intra-abdominal irrigation at the time of cesarean delivery increased maternal GI discomfort without affecting infection rates. We hypothesized that avoiding intra-operative irrigation at the time of cesarean delivery will decrease intra-operative nausea and vomiting without increasing maternal infectious morbidity, post-operative pain, return of bowel function, or time to discharge.
The purpose of this study is to compare the post-surgical standard-of-care dressing to the Prevena™ Incision Management System in women undergoing Cesarean section surgery.
The purpose of this study is to evaluate the incidence of wound breakdown or wound infection following skin closure with Insorb subcuticular absorbable staples versus metal staples after cesarean section through a retrospective chart analysis.
The Cesarean Section Optimal Antibiotic Prophylaxis (C/SOAP) study is a large pragmatic multi-center randomized clinical trial designed to evaluate the comparative effectiveness and safety of azithromycin-based extended-spectrum antibiotic prophylaxis (azithromycin plus standard narrow-spectrum cephalosporin) relative to standard single-agent cephalosporin (preferably prior to surgical incision) to prevent post-cesarean infection. Hypothesis: Compared to narrow-spectrum prophylaxis (i.e. cefazolin alone, or clindamycin if cephalosporin allergy) prior to surgical incision, the addition of extended-spectrum prophylaxis (azithromycin + cefazolin) reduces the incidence of post-cesarean infection.
The purpose of this study is to evaluate if preoperative antibiotics, followed by 48 hour course of broad spectrum antibiotics prevents wound infection complications in patients that are obese who undergo cesarean section. Standard antibiotic prophylaxis in all weight women undergoing cesarean section is cefazolin prior to skin incision. It is the hypothesis that a prolonged, 48 hour course of broad spectrum antibiotics that are suited to prevent growth of normal vaginal flora will decrease the rate of surgical site infection in obese patients that are at a greatly increased risk of postoperative infections complications.
The objective of the project is to find out whether cleansing the vagina before a cesarean delivery decreases the risk of complications and infections after having the baby. If this is the case, cleansing the vagina before cesarean delivery can help improve outcomes for many women and make their early postpartum recovery much more pleasant, giving a healthier start for the family.
This is a randomized, double-blinded placebo controlled trial of cefazolin timing before cesarean section fo infection prophylaxis. Subjects are randomized to cefazolin either 30 minutes prior to skin incision or at time of cord-clamping. Primary outcome is infectious morbidity including wound infections and endometritis.
This will be an open label pilot randomized controlled clinical trial. Women undergoing cesarean delivery will be randomized to have standard wound dressing care or chlorohexidine gluconate (CHG) impregnated wound dressing (ReliaTect™ Post-Op Dressing).
A randomized controlled, parallel group, superiority, open-label, single-institution, Phase 3 interventional clinical trial to evaluate clinical outcomes in obese gravidas undergoing elective cesarean delivery whose wounds were dressed with the PICO Negative Pressure Wound Therapy (NPWT) versus the standard dressing. We hypothesize that the PICO NPWT will reduce the incidence of surgical site occurrences and interventions and postoperative readmissions in obese women. The study will compare surgical site occurrences and surgical incision intervention incidence within 42 +/- 10 days post cesarean delivery in obese women who have the current standard-of-care dressing versus the PICO NPWT.