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Tissue Adhesions clinical trials

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NCT ID: NCT01998633 Completed - Clinical trials for Chronic Granulomatous Disease

Reduced Intensity Conditioning for Hemophagocytic Syndromes or Selected Primary Immune Deficiencies (BMT CTN 1204)

RICHI
Start date: December 2013
Phase: Phase 2
Study type: Interventional

HLH, HLH-related disorders, Chronic Granulomatous (CGD), HIGM1, Immune dysregulation, polyendocrinopathy, enteropathy, and X-linked inheritance (IPEX) and severe LAD-I represent primary immune disorders that are typically fatal without Hematopoietic Cell Transplant (HCT). However, transplant is often complicated by inflammation, infection and other co-morbidities. In addition, these disorders have been shown to be cured with partial chimerism, making them an ideal target for the use of reduced intensity approaches, where a portion of patients may not achieve full donor chimerism, but instead achieve stable mixed chimerism. Reduced-intensity conditioning strategies have demonstrated improved survival with decreased Treatment Related Mortality (TRM) in institutional series for patients with HLH (Cooper et al., 2006; Marsh et al., 2010; Marsh et al., 2011). However, graft loss and unstable chimerism remain challenges. An institutional case series from Cincinnati Children's Hospital demonstrated full or high-level chimerism and improved durable engraftment using intermediate (Day -14) timing alemtuzumab (Marsh et al., 2013b). This study aims to test the efficacy of the Intermediate RIC strategy in a prospective multi-center study including HLH as well as other primary immunodeficiencies where allogeneic transplant with RIC has been shown to be feasible and stable chimerism is curative.

NCT ID: NCT01971060 Withdrawn - Infertility Clinical Trials

a Study to Evaluate Adhesion Risk in Fertility Patients' Status Post Laparoscopic Myomectomy.

VLocmyo
Start date: August 2013
Phase: N/A
Study type: Interventional

Premenopausal Women ages 18-42 will undergo a laparoscopic myomectomy. Prior to the myomectomy, adhesions will be assessed using a modified AFS scoring technique. All investigators will provide usual and customary care to research subjects during the first look laparoscopy. This includes the use of all standard practice anti-adhesive agents and heparinized irrigation fluids.V-Loc 180 suture will be utilized in all patients. All patients will then be evaluated by means of a second look laparoscopy (SLL) 6-12 weeks after the initial surgery and reevaluated via modified American Fertility Society scoring techniques. An independent reviewer will also score adhesions utilize a video recording made from the second look laparoscopic surgery. Patients will be contacted both 1 and 4 weeks post -op and assessed for complications. It is the expectation that patients will show no greater post-operative adhesion formation and a <1% complication rate. Time and ease of suturing will also be evaluated. It is expected that the V-Loc suturing technique will show significantly reduced suturing time, be easier to use, and will be associated with minimal adhesions.

NCT ID: NCT01895933 Completed - Wound Healing Clinical Trials

Efficacy and Safety of the Investigational Device, SurgiShield Anti-Adhesion Barrier Gel

Start date: March 2012
Phase: N/A
Study type: Interventional

This clinical trial is intended to evaluate the impact, efficacy, and safety of Chitosan formulated adhesion inhibitor, SurgiShield when used in the process of wound healing after endoscopic sinus surgery.

NCT ID: NCT01889251 Completed - Clinical trials for Symptomatic Vitreomacular Adhesion

A Phase III Study of A01016 in Subjects With Symptomatic Vitreomacular Adhesion

Start date: July 2013
Phase: Phase 3
Study type: Interventional

The purpose of this study is to evaluate the superiority regarding vitreomacular adhesion (VMA) resolution of a single intravitreal injection of A01016 (Ocriplasmin) compared to sham-injection in subjects with symptomatic VMA.

NCT ID: NCT01872650 Recruiting - Clinical trials for Postoperative Adhesions

A Trial to Assess the Effect and Safety of the C-Qur™ Film

CLIPEUS
Start date: September 2014
Phase: N/A
Study type: Interventional

Adhesions develop in more than 90% of patients undergoing an intra-abdominal surgical leading to serious consequences and complications at reoperation. The investigators initiate a prospective, randomized, controlled, multicenter trial to assess whether the use of C-Qur™ Film decreases the incidence of adhesion formation in subjects undergoing colorectal surgery. Treatment with the application of C-Qur™ Film as an adhesion prevention barrier for colorectal surgery will be compared with the control group at the second stage ostomy takedown procedure. The primary outcome evaluation will be assessment of adhesions to the incision site.

NCT ID: NCT01819467 Terminated - Tissue Adhesions Clinical Trials

A Trial to Reduce Adhesions Following a Primary Cesarean Section

Start date: June 2014
Phase: N/A
Study type: Interventional

The primary objective of this study is to determine whether the use of Seprafilm reduces the incidence rate of adhesion formation following a primary C-section. A secondary objective of the study will be to determine whether or not a correlation between the adhesion score and the difficulty or delay in delivery of the infant exists.

NCT ID: NCT01794221 Completed - Adhesions Clinical Trials

The Role of 2-octyl Cyanoacrylate in Prevention of Recurrent Adhesions After Circumcision

Circglue
Start date: November 2012
Phase: N/A
Study type: Interventional

The objective of this study is to evaluate whether 2-octyl cyanoacrylate skin adhesive decreased the incidence of recurrent adhesions after circumcision. The investigators hypothesize that the incidence of recurrent adhesions will be decreased with use of 2-octyl cyanoacrylate skin adhesive.

NCT ID: NCT01720966 Completed - Adhesions Clinical Trials

Adhesions After Open Versus Laparoscopic Resection of Colorectal Malignancies Detected During Liver Resection

ALIVE
Start date: January 2013
Phase: N/A
Study type: Observational

Rationale: Adhesion formation is a frequent complication after abdominal surgery. Adhesion formation might be reduced by laparoscopic surgery, however sound evidence is lacking. Colorectal surgery would be a good clinical model to investigate adhesion formation between open and laparoscopic surgery because of the adhesion formation propensity of colorectal surgery. However, a randomized controlled study to provide direct evidence is unlikely because of large numbers of patients needed for such a trial and the difficulty to check for adhesion formation at second surgery. Therefore we investigate adhesion formation after laparoscopic and open colorectal surgery for malignancy at liver surgery for metastases. Objective: The aim of our study is to compare the incidence of adhesions after laparoscopic versus open surgery for colorectal malignancies during liver resection for colorectal metastases. Study design: The study is designed as a prospective observational cohort study. Study population: All consecutive, adult patients undergoing laparotomy or laparoscopy for intended liver resection or radio frequency ablation for liver metastases of a colorectal malignancy in whom inspection of the middle and lower abdomen is possible to map adhesions. Main study parameters/endpoints: - Primary endpoint is incidence of adhesions to the ventral abdominal wall around the site of the original incision. - Secondary endpoints are episodes of bowel obstruction between index surgery and liver surgery; total incidence of adhesions; extent of adhesions; Zühlke classification of adhesions; performance of adhesiolysis; duration of adhesiolysis; peroperative complications: enterotomy, seromuscular injury, inadvertent organ injury during adhesiolysis; postoperative complications: delayed diagnosed perforation, SAE's. Nature and extent of the burden and risks associated with participation, benefit and group relatedness: This study is an observational study. The existence of adhesions will be assessed during laparotomy or laparoscopy for the treatment of liver metastases. The laparotomy is indicated for medical treatment and should not be enlarged solely for the assessment of adhesions nor will the operating time be influenced for this purpose. Adhesions and peroperative complications have to be scored by the operating surgeon during or directly after surgery. The postoperative complications have to be scored during the postoperative course by the doctors on the ward. These assessments do not interfere with the treatment of the patients.

NCT ID: NCT01701193 Completed - Pelvic Adhesions Clinical Trials

A Clinical Study of Alanyl-Glutamine for Reduction of Post-Myomectomy Adhesions

Start date: February 15, 2015
Phase: Phase 1/Phase 2
Study type: Interventional

This study evaluates whether L-Alanyl-L-Glutamine can reduce the incidence, extent and severity of adhesions after myomectomy. Half of the participants will receive L-Alanyl-L-Glutamine and the other half of participants will receive a saline placebo at the time of myomectomy.

NCT ID: NCT01632202 Terminated - Clinical trials for Intrauterine Adhesions

Seprafilm Slurry in the Prevention of Uterine Scarring in Patients Undergoing Hysteroscopic Myomectomy

Seprafilm
Start date: May 2012
Phase: Phase 4
Study type: Interventional

Seprafilm is an FDA-approved temporary bioresorbable barrier that physically separates opposing tissue surfaces. The physical presence of the membrane separates adhesiogenic tissue while the normal tissue repair process takes place. When used in the abdominopelvic cavity, it has been shown to reduce the incidence of adhesions. The intrauterine cavity is a potential space where the walls of the uterus are collapsed upon itself in the normal state. It has been demonstrated that the trauma of removing a submucosal fibroid with electrocautery exposes the uterus to great potential for intrauterine adhesions since the raw charred surface is directly opposed to the opposite endometrial surface. Previous studies have shown that the placement of hyaluronic acid in the intrauterine cavity after a myomectomy is not only safe, but also decreases the incidence of intrauterine adhesions. The investigators hypothesize that by placing a slurry of Seprafilm in the intrauterine cavity and creating a temporary physical barrier between the walls of the uterus, that they will be able to prevent iatrogenic intrauterine adhesions. Given that approximately 24 to 48 hours after placement, the membrane becomes a hydrated gel that is slowly resorbed within one week, the investigators anticipate that the patient will have minimal to no discomfort; since no physical device is being left in the endometrial cavity, the uterus will not be contracting more than it does in its normal postoperative state.