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Lacerations clinical trials

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NCT ID: NCT04573504 Recruiting - Clinical trials for Vaginal Laceration During Delivery

Antibiotics for Severe Perineal Laceration to Prevent Infection Following Repair

ASPIRe
Start date: September 23, 2020
Phase: Phase 4
Study type: Interventional

Many women experience severe anal sphincter lacerations during childbirth, which put them at risk for infection, improper healing, and accidental bowel leakage. This study aims to determine if oral antibiotics following vaginal delivery in women with severe tears can prevent wound infection and breakdown, and ultimately, accidental bowel leakage. Women who suffer a severe vaginal laceration will be randomized to receive 5-days of oral antibiotics or placebo pills after getting a standard one-time dose of IV antibiotics at the time of repair. All women will have immediate, intensive follow-up with an Urogynecologist at our well-established PEAPOD peripartum clinic at 1 week, 2 weeks, and 3 months postpartum to monitor wound healing and infection. At these visits, we also will assess women's perception of their well-being, perineal pain, and bowel symptoms. All participants will be invited to remain in the study for long-term follow-up. Our goal is to establish whether a five-day course of oral antibiotics should be a standard part of clinical care for severe postpartum lacerations.

NCT ID: NCT04557761 Recruiting - Wound Heal Clinical Trials

Comparison of microMend® Devices to Sutures in Closing Lacerations in Children

Start date: July 13, 2020
Phase: N/A
Study type: Interventional

This study will gather information on the use of microMend® to repair lacerations in children and compare the efficacy of microMend® to sutures for laceration repair. microMend® has previously been shown to be less painful and easier to use than sutures, which are the current standard of care for primary wound closures. Results of this research will inform how the treatment of laceration repairs in the pediatric patient population.

NCT ID: NCT04536493 Completed - Laceration of Skin Clinical Trials

Comparison of 2 Application Techniques for LET Gel Used Prior to Simple Laceration Repair

LET
Start date: June 19, 2019
Phase: Phase 4
Study type: Interventional

To compare pain scores during laceration repair with first suture placement using standardized visual analog scale (VAS) between 2 different topical local anesthetic application techniques for using LET gel. Specifically, the investigators are studying if applying LET gel 3 times, spaced 10 minutes apart (triple LET) provides superior anesthesia to one 30 minute application (single LET). Single LET is the current standard method of application.

NCT ID: NCT04513405 Not yet recruiting - Estrogen Deficiency Clinical Trials

Estrogens Levels and Receptors Status and Skin Tears

ESKITE
Start date: September 1, 2020
Phase: N/A
Study type: Interventional

Background: Skin tears (ST) or "laceration injuries" or "flap wounds" are injuries that are often found in residents of residential care facilities (RCFs). STs were first defined by Payne and Martin in 1993 as traumatic wounds, located mainly in the upper limbs, caused by "shearing, friction or mechanisms combined with the consequent separation of layers of skin. Skin Tears can cause psychological problems for the patient and represent an economic problem with important repercussions on both the patient and the community. The etiology suggests that the physiological changes of the skin related to old age, together with comorbidity, are among the main risk factors for their onset. The precise data on the phenomenon are not many, but it is estimated that STs are much more frequent than the same pressure ulcers, observing prevalence rates in RCFs around 40% Therefore, there are several risk factors hypothesized so far. Much evidence has correlated, in various physiological or pathological conditions, the role of estrogens with the functions and aging of the skin. Objectives: The project will develop on the analysis of populations of residents from RCFs belonging to the national territory. Two populations of residents cared in the RCF will be recruited. A group of subjects suffering from skin tears (group A) and a control group of subjects without skin tears (group B). The inclusion of patients in both groups will take place through a simple randomization procedure. Group A patients will be staged according to the STAR classification for skin tears. For each group a peripheral venous blood sample will be taken (to measure the levels of estrone and estradiol) and a skin biopsy will be performed in order to measure estrogen receptors (ERs) expression. A data collection sheet with angraphic and anamnestic data will be developed to correlate the demographic and comorbidity data with the clinical conditions of the patients and with the laboratory findings from the sampling. Expected results: The primary endpoint will be the correlation between serum estrogen levels, receptor expression and the presence of skin tears. The secondary endopoint will be Correlation between receptor structure and clinical staging of skin tears. Future prospectives: We believe that our study may open new frontiers in the prevention and in the management of these skin lesions.

NCT ID: NCT04378283 Completed - Skin Lacerations Clinical Trials

Prospective Evaluation of Topical Anesthesia in Children

LET
Start date: May 2016
Phase: N/A
Study type: Interventional

This study is designed to assess efficacy and comfort of LET solution vs. EMLA cream and topical infiltration of lidocaine.

NCT ID: NCT04270019 Withdrawn - Nerve Injury Clinical Trials

Polyethylene Glycol to Improve Sensation Following Digital Nerve Laceration

Start date: June 26, 2020
Phase: Phase 1/Phase 2
Study type: Interventional

PEG is a fusogen, a type of chemical that aids in mediating cell fusion. PEG helps nerve cells recover neuronal continuity by removing plasmalemmal-bound water which opens the axonal ends on both sides of the injury. Opening axonal ends permits the nerve ends to reconnect and begin regeneration. PEG has been tested on animal models extensively and in earthworm models has been shown to induce fusion rates in 80-100% of neuronal cells. In crushed or severed mammalian sciatic nerves PEG has enhanced neuronal continuity to baseline functioning levels. Human applications for PEG have been tested by Bamba and colleagues in a case series with encouraging results. No studies, to our knowledge, have prospectively examined the use of PEG in peripheral nerve injuries. We propose a placebo controlled, double-blinded randomized controlled trial to test the hypothesis that local PEG administration can enhance sensory nerve regeneration following digital nerve transection compared to surgery alone.

NCT ID: NCT04203225 Completed - Pain, Procedural Clinical Trials

Comparison of Two Application Techniques for LET Gel

Start date: May 22, 2017
Phase: Phase 4
Study type: Interventional

Comparison of anesthetic efficacy of Lidocaine (4%), Epinephrine (0.1%), and Tetracaine (0.5%) topical gel (LET) applied three times for 10 minutes each time vs. once for 30 minutes prior to suturing simple lacerations in children aged 7-17 years.

NCT ID: NCT04122859 Recruiting - Laceration of Skin Clinical Trials

Evaluation of Zip Device to Conventional Sutures for Laceration Repair in Pediatrics in an Emergency Department

ZIPPED
Start date: November 1, 2018
Phase: N/A
Study type: Interventional

A prospective, randomized, controlled post-market clinical investigation that will enroll pediatric subjects requiring laceration repair. The investigation population will consist of 30 subjects fulfilling the eligibility criteria for the clinical investigation. The subjects will be randomly assigned at a 1:1 ratio to either the Zip 4 Surgical Skin Closure Device group or the Standard of Care sutures group.

NCT ID: NCT04091672 Completed - Infection Clinical Trials

RECELL® System Combined With Meshed Autograft for Reduction of Donor Skin Harvesting in Soft Tissue Reconstruction

Start date: March 2, 2020
Phase: N/A
Study type: Interventional

A prospective randomized within-subject controlled study to compare the clinical performance of conventional autografting with and without the RECELL system on acute non-burn full-thickness skin defects.

NCT ID: NCT04056013 Recruiting - Clinical trials for Traumatic Lacerations

Vicryl Rapide Versus Nonabsorbable Suture

Start date: September 26, 2019
Phase: N/A
Study type: Interventional

This will be a prospective, randomized controlled trial assessing noninferiority of Vicryl Rapide compared to nonabsorbable suture. The study will be conducted in the Community Regional Medical Center emergency department (ED). The aim of this study, then, is to prospectively determine if 3-month cosmesis for traumatic laceration repair of trunk/extremity lacerations in adult patients with Vicryl Rapide is noninferior to nonabsorbable suture.