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Wounds clinical trials

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NCT ID: NCT01339429 Completed - Wounds Clinical Trials

Simplified Negative Pressure Wound Therapy

Start date: March 2011
Phase: Phase 1
Study type: Interventional

The objective of this study is to implement a simplified Negative Pressure Wound Therapy (sNPWT) device in a low resource setting. The investigators hypothesize that the sNPWT device is at least equivalent to commercially available NPWT devices. Therefore, the specific aims of this study will be to measure: 1. the mechanical properties of the sNPWT device and 2. the adverse events associated with the sNPWT device.

NCT ID: NCT01319149 Completed - Wounds Clinical Trials

A Study of the Effects of Molecular Diagnostic Directed Wound Gels on Wound Care Outcomes

Start date: November 2010
Phase: N/A
Study type: Observational

A retrospective molecular diagnostic review on wound care outcomes. The time periods include March, April, May of 2010.The retrospective review would analyze the days of healing during the timeframe, upon the introduction of molecular diagnostic testing

NCT ID: NCT01295177 Completed - Diabetes Mellitus Clinical Trials

Topic Insulin Accelerates Wound Healing in Diabetes

insulin
Start date: January 2004
Phase: Phase 1/Phase 2
Study type: Interventional

The purpose of this study is to determine whether topic insulin is effective to accelerates wound healing in diabetes patients

NCT ID: NCT01227759 Completed - Wounds Clinical Trials

Tyrosur® Gel-Investigation on Wound Healing Efficacy

Start date: September 2010
Phase: Phase 2
Study type: Interventional

This IIa study with intraindividual comparison of treated versus untreated to assess the wound healing efficacy of Tyrosur® Gel after experimental impairment of the skin using an abrasive wound healing model.

NCT ID: NCT01213420 Completed - Wounds Clinical Trials

Aruba Aloe Formula F-BC-096 in the Treatment of Split Thickness Donor Site After Wound Closure

Start date: January 2010
Phase: Phase 4
Study type: Interventional

This study is a prospective, randomized controlled, double blinded, study in a multi centre setting. Three burn centres will include 60 patients in total. If suited for the study (= two equal donor sites) and after informed consent, patients will be observed starting the day of skin prelevation. A coded file will be made for each patient and these files should contain the localization of both donor sites, their depth as determined by the setting of the dermatome and the treatment. Treatment for both donor sites will always be equal. The date of wound healing of each donor site, which may only differ by a maximum of five days, will be noted. Digital photographs of the healed donor sites will be taken and the scars will be evaluated by the local researchers using the Adapted Vancouver Scar Scale prior to the start of hydration. From that moment on one donor site will be treated with Aruba Aloe formula F-BC-096 while one of the control products will be applied to the second site. Per group of five patients per centre a different control product will be applied to the second donor site. The tubes containing these products will be colour and numerical coded. Nor the treating personnel, nor the patients will be informed which colour tubes contain the control products and which contain the Aruba Aloe formula F-BC-096. If it is necessary to apply pressure garments for one donor site, the garments will be applied for both sites. Follow-Ups will be performed on one, three and six months after wound closure. Objective methods will be used during these follow-ups to evaluate elasticity and colour of the scar, this by using the Dermalab, the Cutometer®, the Derma Spectrometer and the Mexameter®. The evaporation, permeability and hydration of the scar will be measured by using the Tewameter® and the Corneometer®. The Reviscometer® will measure the direction of collagen and elastin. The Adapted Vancouver Scar Scale will be used as a subjective method. Also different scales for evaluation of donor site pain, patient satisfaction, product comfort, itching etc. have to be completed by the patient.

NCT ID: NCT01153620 Completed - Wounds Clinical Trials

The Antiseptic Efficacy and Tolerability of Lavasept® 0.04% on Acute Traumatic Wounds

Lavasept 2
Start date: August 2010
Phase: Phase 4
Study type: Interventional

The primary objective of the study is to assess the antiseptic efficacy of Lavasept 0.04% when used as an antiseptic agent and to compare these with Ringers' solution in patients with acute traumatic wounds.

NCT ID: NCT01113307 Completed - Wounds Clinical Trials

The Use of CureXcellTM in a Community Setting for the Treatment of Hard to Heal Wounds

Start date: May 2010
Phase: N/A
Study type: Observational

The primary objective of the study is to define procedures for the use of CureXcellTM in the community through Clalit Health Services. Secondary objective is to evaluate the blinding method in a subgroup of patients, which will be used in a future study named: a multinational, multi-center, randomized, double blind, placebo controlled study for the evaluation of the tolerability, safety and efficacy of CureXcell™ therapy plus adequate ulcer treatment, in diabetic patients with ulcers in the lower extremities. Adults with chronic ulcers; pressure ulcers, venous ulcers, diabetic foot ulcers or post operative ulcer will be recruited to the study. Patients that have been recruited for the study will be treated as required for their medical condition. As required, cultures will be taken, IV or PO antibiotics will be given and debridement will be carried out. Patients will be referred to catheterization, revascularization, or amputation as required and the decision to do so will not be affected in any way by the study. CureXcellTM will be used as adjunct treatment to good ulcer care (GUC).

NCT ID: NCT01107821 Completed - Wounds Clinical Trials

Negative Pressure Wound Therapy With the Engenex™-Pump and Bio-Dome™ Dressing, an Evaluation

Start date: February 2010
Phase: Phase 4
Study type: Interventional

Negative pressure wound therapy (NPWT) has become a powerful tool in wound bed preparation of complex wounds and is routinely used in various disciplines, including general surgery and plastic surgery. NPWT involves the creation of a controlled subatmospheric pressure in the wound bed. The vacuum is generated by a pump and is distributed over the wound bed by a dressing (mostly a foam or gauze sponge). The therapy has several positive effects on the wound bed, such as improved local blood circulation, stimulation of granulation tissue formation and controlled evacuation of wound exudates. Standard negative pressure applied mostly varies between -120 mmHg and -130 mmHg.A new way of applying NPWT is the Engenex™ system using the Bio-Dome™ Wound Dressing, a specially engineered structure that forms a defined space above the surface of the wound. This space will maintain its size and integrity in the presence of negative pressure and wound fluids and thus effectively imposes strain on the underlying tissue. The material properties of the dressing permit moist wound healing while encouraging efficient removal of exudates. The contact material will not absorb fluid. It has been clinically shown that the Bio-Dome™ Wound Dressing is effective at growing granular tissue in the base of a wound at a safe low negative pressure of -75 mmHg, possibly reducing dressing ingrowth into the wound bed to a minimum. Our intention is to evaluate NPWT by means of the Engenex™ pump and Bio- Dome™ Wound Dressing in 15 patients. Patients with large soft tissue defects will be examined by a plastic surgeon and if suitable for NPWT they will be treated with the Engenex™ NPWT system. Before starting NPWT wounds will be evaluated and measured (length, width, depth, volume) if possible. Digital photos will be made and wound swabs will be taken for microbiological examination.Dressing changes will be performed twice weekly, on Monday and Thursday or on Tuesday and Friday. At each dressing change a wound will be re-evaluated and measured. Other parameters to be noted will be, amongst others: pain, comfort, ease of use,material used, time needed for dressing change, etc. The NPWT treatment will be carried on for maximum three weeks. During this period plastic surgeons will evaluate whether the wound is ready for surgical closure or not. If surgical closure after 3 weeks is not yet an option possibility exists that NPWT will be continued. Every wound will be followed up until complete wound healing after surgical closure. All patients data will be recorded, secured, evaluated and analysed for both medical parameters and health economic parameters.

NCT ID: NCT01089673 Completed - Wounds Clinical Trials

A Retrospective Study of the Effects of Molecular Diagnostics on Wound Care Outcomes

Start date: March 2010
Phase: N/A
Study type: Observational

A retrospective molecular diagnostic review on wound care outcomes between two time periods. The time periods include June, July, August of 2008 and June, July, August of 2009. The retrospective review would analyze the days of healing during those two timeframes, upon the introduction of molecular diagnostic testing.

NCT ID: NCT01038986 Completed - Wounds Clinical Trials

A Post-marketing Observational Study of Cell Therapy for Chronic Wounds

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

A post-marketing multi-center observational study to provide data describing the safety and effectiveness of CUREXCELL™ as it is applied in a real-life setting for treatment in patients with chronic and/or refractory wounds.