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Thermal Injury clinical trials

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NCT ID: NCT04044014 Completed - Thermal Injury Clinical Trials

Gellan Contact Study

GCS
Start date: October 10, 2016
Phase: N/A
Study type: Interventional

The primary objective of this study will be to establish the safety of the two different Gellan formulations (sheet and fluid gel) following its application to the epidermis of healthy volunteers. This will be compared to a control dressing-- Mepitel One (Polyurethane net with soft Silicone).

NCT ID: NCT02080546 Completed - Thermal Injury Clinical Trials

Vaginal Cuff Dehiscence and Thermal Injury During TLH

Start date: December 2009
Phase: N/A
Study type: Interventional

Purpose of the study Part 1: Retrospective Review: The purpose of part 1 is to establish the historical rate of vaginal cuff dehiscence following total laparoscopic hysterectomy compared to total abdominal hysterectomy (TAH), total vaginal hysterectomy (TVH), radical hysterectomy (RH) and laparoscopic-assisted vaginal hysterectomy (LAVH) at Duke University Medical Center. Part 2: Prospective Randomized Controlled Trial: The purpose of part 2 is to determine if the mode of electrothermal colpotomy incision affects (1) the degree of thermal injury at the time of laparoscopic hysterectomy or (2) the incidence of clinical surrogates of compromised vaginal cuff healing. Women already scheduled for TLH will be randomized to colpotomy incision with the V mode or standard cut/coag form of electrothermal energy. Prevalence of vaginal cuff injury will be calculated, and cross tabulation tables will be used to examine the association fo dehiscence with proposed risk factors in the retrospective part of the study. In the randomized controlled trial, depth of thermal injury will be compared between the two groups, and a chi-square test will be used to test for a difference in clinical outcomes between the two groups. There is little risk associated with this study above the normal surgical risks; however, the V mode has not been previously been studied for its use in making a colpotomy incision. Loss of confidentiality is a risk of the study, but all samples will be de-identified and given a unique study number, and only individuals directly involved in the study will be given access to the study information.

NCT ID: NCT01664806 Completed - Clinical trials for Intraoperative Complications

Laparoscopic Cholecystectomy And Capacitive Coupling - Coag Versus Blend Mode Causing Thermal Injury at Port Site Skin

Start date: November 2010
Phase: Phase 3
Study type: Interventional

Monopolar radiofrequency energy is used to perform the laparoscopic cholecystectomy operation. The appearance of burns are common following laparoscopic cholecystectomy; particularly at the port site of the active electrode. Willson et al found that 9 out of 19 skin biopsies from the skin adjacent to the port site of the monopolar instrument's active electrode were found to have thermal injury by histology. [Willson et al. Surg Endosc (1997) 11:653] Authors have speculated that using different generator modes may lead to less capacitive coupling; [Wu et al Am J Surg (2000) 179: 67] although no data exists to support these speculations. The investigators hypothesize that capacitive coupling electrosurgical injuries from monopolar instruments are occurring during laparoscopic cholecystectomy operations. The investigators hypothesize that use of blend modes will reduce the incidence of capacitive coupling thermal injuries during laparoscopic operations in comparison to coag modes.

NCT ID: NCT00748345 Completed - Thermal Injury Clinical Trials

Pharmacokinetics of Caspofungin in Burn Patients

Caspo-brûlés
Start date: February 2009
Phase: Phase 2/Phase 3
Study type: Interventional

Drug pharmacokinetics of antimicrobial agents is significantly altered in the burn patients. Additionally, burn patient population exhibits a wide inter- and intrapatient variation in drug handling. Several investigations carried out in burn patients treated with e.g. fluconazole showed the requirement to increase daily dose in comparison with healthy volunteers. However, no pharmacokinetic data are available of caspofungin in the burn population. The aim of this investigation is to investigate pharmacokinetics of caspofungin in burn patients after a single usual dose (70 mg i.v.), in order to determine the optimal dose in this population.