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Pain, Intractable clinical trials

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NCT ID: NCT02091076 Completed - Pain, Intractable Clinical Trials

Efficacy and Safety of Silk Fibroin With Bioactive Coating Layer Dressing

Start date: March 2014
Phase: Phase 1/Phase 2
Study type: Interventional

A split-thickness skin graft (STSG) is used for a large wounds or wounds that cannot be closed by primary and secondary wound closure. Accelerated re-epithelialization rate and minimizing pain and infection are main goals of donor care. Traditionally dressings are inexpensive but adhere to the wound surface and cannot absorb exudates. Thus, we have developed a new biomaterial based on Thai silk for wound dressing application. Silk fibroin and silk sericin were selected to produce wound dressing in this study. The objective of this study is to compare wound dressing containing silk fibroin with bioactive coating layer with standard dressing (medicated paraffin gauze dressing; Bactigras®), with regard to healing time, patients' pain intensity, skin's transepidermal water loss after healing and evidence of infection in the treatment of split-thickness skin graft donor sites. The study design is a randomized, controlled, self paired clinical trial. Patients age 18 to 60 years and undergo STSG at thigh in Department of Surgery, King Chulalongkorn Memorial Hospital will be recruited in the study. The exclusion criteria are donor sites other than thigh area or located at high risk of infection. Patients who are immunocompromised or diabetes mellitus or psychiatric disorders or low serum albumin level (less than 3.0 g/dL) or known allergic to SS or SF or paraffin or chlorhexidine acetate are also excluded. All subjects sign the informed consents after discussion the protocol, benefits and risks. The donor site will be divided into two equal halves, each site will be randomized to receive the tested material or the medicated paraffin gauze dressing. The donor site wounds will be observed daily. The dressings will not be changed, except when they are fully soaked with exudates and easily fell off or any sign of infection. Healing time will be recorded when the dressing separate completely from the donor site, no exudates and no pain when the donor site is exposed to air. The patient's pain level will be evaluated with the visual analogue scale and the donor site wounds will be observed daily for signs of infection. On the day of the wound is recorded for healing time and 1 weeks, 1, 2, 3, 4 and 5 months after that, the skin barrier function (TEWL) of each site will be measured using a Tewameter. Blood sample will be collected from patients pre- and postoperatively (within day 3) for hepatic and renal function analysis.

NCT ID: NCT02036281 Completed - Pain, Intractable Clinical Trials

A Phase 1 Study of Substance P-Saporin in Terminal Cancer Patients With Intractable Pain

Start date: January 2014
Phase: Phase 1
Study type: Interventional

The subjects will be treated with a single dose of SP-SAP. They will receive the study drug SP-SAP via a percutaneous intraspinal catheter, they will be monitored for 4 hours and required to stay in the hospital for 24 hours for precautionary care. Their vital signs will be monitored and recorded immediately following the injection. After the catheter has been removed, the following assessments will be made physical exam including motor and sensory functions, and electrocardiogram. A neurologist will be available for consultation as needed. Beginning dose of SP-SAP will be 1 -mcg for the first cohort. Subsequent single patient dose cohorts as 2, 4, 8, 16, 32, 64 and 90 mcg intrathecally (into the spine). SP-SAP will be accrued and treated after four weeks observation for toxicities between cohorts. Study duration will be up to 6 months from the start of SP-SAP administration.

NCT ID: NCT01854229 Completed - Chronic Pain Clinical Trials

Prometra Post-Approval Study

Start date: June 20, 2013
Phase: N/A
Study type: Interventional

The Prometra Pump is approved by the FDA for use in the United States. The purpose of this study is to collect long-term safety data on the Prometra Pump.

NCT ID: NCT01665040 Completed - Chronic Pain Clinical Trials

Clinical Outcomes Study Using a New Implantable Neurostimulation System for Chronic Intractable Pain

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

The primary objective of this study is to investigate patient satisfaction with treatment using a new implantable neurostimulation system for chronic pain of the trunk and/or limbs.

NCT ID: NCT01567345 Completed - Advanced Cancer Clinical Trials

Intrathecal Morphine Administration Using Implantable Pump With Continuous or Programmable Flow

PITAC
Start date: January 14, 2009
Phase: N/A
Study type: Interventional

The aim of this study is to compare intrathecal morphine administration: using a pump with continuous or programmable flow.

NCT ID: NCT01539980 Completed - Pain, Intractable Clinical Trials

Clinical Study on Silk Sericin Wound Dressing for Split-thickness Skin Graft Donor Sites Treatment

Start date: August 2012
Phase: Phase 1/Phase 2
Study type: Interventional

1. Silk sericin wound dressing may reduce time for complete epithelialisation of split-thickness skin graft donor sites compared to Bactigras®. 2. Silk sericin wound dressing may reduce pain level at split-thickness skin graft donor sites compared to Bactigras® . 3. Silk sericin wound dressing may not cause split-thickness skin graft donor sites infection as compared to Bactigras®. 4. Split-thickness skin graft donor sites which treat by silk sericin wound dressing may not cause significant adverse events.

NCT ID: NCT01291901 Completed - Neoplasms Clinical Trials

NP2 Enkephalin For Treatment of Intractable Cancer Pain

Start date: January 2011
Phase: Phase 2
Study type: Interventional

The purpose of this study is to examine the impact of intradermal delivery of NP2 on pain scores and pain medication usage in subjects with intractable pain due to malignant disease. A second purpose is to confirm safety and secondary efficacy measurements.

NCT ID: NCT01166906 Completed - Pain, Intractable Clinical Trials

Pain Blocking During Drug Administration or Blood Collection With Needles

Start date: March 2010
Phase:
Study type: Observational

There is a gating mechanism in the dorsal horn of the spinal cord that acts to facilitate or inhibit transmission of pain signals to the brain. The gate can be closed by mechanical stimuli such as touch and vibration.

NCT ID: NCT00817596 Completed - Intractable Pain Clinical Trials

Prometra's Utilization in Mitigating Pain (PUMP)

PUMP
Start date: January 2007
Phase: N/A
Study type: Interventional

Clinical evaluation of the safety and efficacy of the Prometra Programmable Infusion Pump to accurately supply drug to the intrathecal space for the treatment of chronic pain.

NCT ID: NCT00386243 Completed - Pain Clinical Trials

Evaluation of Stepped Care for Chronic Pain in Iraq/Afghanistan Veterans (ESCAPE)

ESCAPE
Start date: December 2007
Phase: N/A
Study type: Interventional

The purpose of this study is to determine if a stepped-care intervention makes pain symptoms better and reduces activity limitations because of pain. Our two primary hypotheses are that in OIF/OEF veterans with chronic pain: 1. Stepped care is more effective than usual care in reducing pain-related disability 2. Stepped care is more effective than usual care in reducing psychological distress