Treatment Trials

190 Clinical Trials for Various Conditions

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4-aminopyridine for Skin Wound Healing
Description

Many patients suffer from chronic non-healing wounds as well as acute wounds. There is a need to develop treatments to accelerate and improve healing of chronic and acute wounds. More research is needed to evaluate the role of 4-aminopyridine (4-AP), a promising new agent with an excellent safety profile, on wound healing. The investigational treatment will be used to evaluate the role of (4-AP) on the treatment of wounds to accelerate wound healing in healthy adults. The purpose of this study is to evaluate the role of 4-AP on the treatment of wounds to accelerate healing. The investigational treatment will be used to test the hypothesis that 4-AP can speed wound healing.

Conditions

Wounds, Wound of Skin, Wound Heal, Wounds and Injuries

Website Application Based Education and Text Messaging in Improving Skin Wound Care in Patients Undergoing Mohs Surgery
Description

This randomized clinical trial studies how well website application (web app) based education and text messaging works in improving skin wound care in patients undergoing Mohs surgery (a surgical procedure used to treat skin cancer). Website application and text messaging based education may help patients stick to wound care instructions before and after surgery, lower anxiety level, and may help monitor their activity.

Conditions

Malignant Skin Neoplasm

Bioelectric Field Imaging Near Human Skin Wounds
Description

The investigators have developed a new non-invasive medical device called the Bioelectric Field Imager. They plan to use this device to measure the electric field near small lancet wounds in 60 volunteers. Their hypothesis is that the electric field is an early stimulus for wound healing and the magnitude of this field will vary with wound healing capability. The investigators will compare the electric fields near arm and leg wounds in males and females in the age groups of 18-30 and 65-80. In addition they will measure these wound fields in diabetics and near chronic ulcers.

Conditions

Wounds

Effects of Topical SLPI on Skin Wounds
Description

This study will evaluate the effects of a protein called secretory leukocyte protease inhibitor (SLPI), on skin wound healing. Produced naturally by the body, SLPI modifies levels of elastase, a substance that breaks down the skin. Older people are at greater risk of impaired wound healing, with increased elastase activity and inflammation. In addition, men heal more slowly than women. Delayed healing is associated with infection and pain and can lead to the development of chronic non-healing skin wounds. Healthy men and women between 60 and 80 years old who wish to participate in this study will have a brief history and physical evaluation to determine their eligibility. Those enrolled will be randomly assigned to receive a gel form of SLPI applied topically (on the skin surface) to a skin wound or a placebo (a look-alike gel with no active ingredient). Participants will undergo the following procedures: First visit - The skin will be numbed with a local anesthetic and two small (4 mm) wounds (about the size of a pencil eraser) made in each upper arm. The drug or placebo will be applied to the wound and gauze placed over it. Two blood samples (20 ml and 7 ml) will be drawn an hour apart to determine blood levels of SLPI. Second visit - The day after the first visit, the wound dressing will be removed and the participant will be evaluated for pain at the wound site, allergic reactions or infection. A blood sample (7 ml) will be taken. Third visit - The wounds will be examined and photographed to evaluate healing. In addition, the strength of the wound may be assessed by means of a vacuum system placed on the skin. (This may cause a tingling sensation over the wound.) A piece of all four wounds will be removed after the skin has been numbed and a dressing applied. Fourth visit - The wounds will be examined for healing and the dressing removed.

Conditions

Healthy, Wound Healing

Effectiveness of Embrace Scar Therapy Device After Cutaneous Wound Closure
Description

The purpose of this study is to determine whether the use of the embrace device after repair of linear cutaneous surgery wounds improves scar cosmesis.

Conditions

Linear Cutaneous Wound

A Case-Control Study of Negative Pressure Platform Wound Devices (NP-PWD) for Skin and Soft Tissue Defects
Description

This study will demonstrate the effectiveness of the NP-PWD therapy in managing complex wounds and improving wound healing parameters as compared to standard of care.

Conditions

Skin Wound, Soft Tissue Injuries

Safety and Efficacy of MRG-001 in Wound Healing in Abdominoplasty Patients
Description

Surgical excisions are one of the most frequent cutaneous wounds. This study will compare the safety and preliminary efficacy of a novel fixed-dose combination drug MRG-001 in pre-abdominoplasty surgical excisions and scar appearance in subjects undergoing elective abdominoplasty.

Conditions

Wound of Skin, Abdominal Wound

Adipose-derived Stem Cells to Treat Chronic Wounds.
Description

The goal of this study is to determine whether autologous, adipose-derived regenerative cells improve the healing of chronic wounds. Ten patients will undergo fat harvest and peri-wound injection of the isolated cells in addition to the standard of care for the treatment of their chronic wound. Wound healing will be followed over 24 weeks.

Conditions

Wound of Skin

StrataGraft Safety, Tolerability and Efficacy in Pediatric Subjects
Description

Autografting is a surgical procedure to transplant healthy skin (donor skin) from another part of the participant's own body (donor site) to the burned part. Autografting is the usual treatment for DPT burns. It works to close the wound, but can cause other problems: * Donor sites are painful, can become infected or scarred, or can even become full thickness (FT) wounds themselves * Treatment problems can require more grafting * Additional surgery increases the risk of medical problems caused by the treatment Stratatech is trying to find a safe and effective alternative to autografting to promote the healing of severe burns. The purpose of this study was to evaluate whether StrataGraft treatment eliminates or reduces the need for autografting and promotes wound closure in a pediatric population with thermal burns that contain intact dermal elements and for which autografting is clinically indicated (DPT burns). Participants were enrolled into one of two age-based cohorts: 2 to \< 12 years and 12 to ≤ 17 years to receive a single application of StrataGraft, in up to 3 non-contiguous DPT burn areas located on the same extremity or plane of the torso.

Conditions

Skin Wound, Burns, Trauma-related Wound

Suprathel® Use During Prolonged Field Care to Promote Healing and Reduce the Need for Grafting of Burn Wounds
Description

The purpose of this study is to determine the effect to which Suprathel® (Polymedics Innovations GmbH, Denkendorf, Germany) can reduce the need for grafting compared to Standard of Care (SoC). Furthermore, the study intends to evaluate if Suprathel® allows for a reduction of reduction of pain, infection, provider workload, scar development and costs compared to SoC.

Conditions

Wound of Skin, Burns

DermaClose DUKE Fasciotomy and Wound Study
Description

To evaluate the clinical performance of DermaClose and DermaClose XL Continuous External Tissue Expander (CETE) devices to reduce wound size and/or assist with closure in acute full thickness wounds of the skin and assess the need for skin grafting for patients undergoing a four-compartment leg fasciotomy.

Conditions

Wound of Skin

Aesthetic Outcome of Running Subcuticular Suture Versus Running Horizontal Mattress Suture Closure of Linear Wounds on the Trunk and Extremities
Description

The purpose of this study is to determine whether the use of running subcuticular suture versus running horizontal mattress suture for the repair of cutaneous linear wounds on the trunk and extremities affects aesthetic outcomes. The study team will use a split wound model, where half of the wound is repaired with running subcuticular sutures and the other half is repaired with running horizontal mattress sutures. Three-months post-surgery, the scar will be evaluated via the patient observer scar assessment scale (POSAS), a validated scar instrument, as well as the trace-to-tape method, an objective outcome measure for linear postoperative scars. Any adverse events will also be recorded.

Conditions

Wound of Skin, Scar

Pilot Study: KeraStat® Gel for Topical Delivery of Morphine for Management of Non-Healing, Painful Open Wounds and Ulcers
Description

This study is intended to provide information from subjects who currently have painful, chronically open wounds and assess the pain reduction capacity of KeraStat® Gel with Morphine. In gathering data from subjects who have baseline pain from their chronically open wounds, the investigators can then evaluate the capacity of KeraStat® Gel plus Morphine in reducing the subjects daily pain levels, pain associated with dressing changes, and pain medication consumption.

Conditions

Wound of Skin, Burns

Comparing a Synergistic Antimicrobial Cleanser and Gel to Normal Saline and an Amorphous Gel in Reducing Bioburden and Promoting Healing in Chronic Lower Extremity Ulcers
Description

The study is a randomized double-blind controlled clinical trial designed to compare healing rates between normal saline wash in combination with an amorphous gel (NSS-HG) versus the grouping of a synergistic antimicrobial cleanser (AMC) and antimicrobial gel (AMG) in chronic lower extremity ulcers. After consenting, the ulcers of eligible subjects are measured, photographed and undergo the MolecuLight imaging procedure (MiX). The subject is then randomized to one of two arms: target ulcer cleansed saline wash and an amorphous gel (NSS-HG) or synergistic antimicrobial cleanser (AMC) and antimicrobial gel (AMG). After cleansing the wound a second MiX is performed. The subject is given a four-week supply.

Conditions

Wound of Skin

Autologous Regeneration of Tissue (ART) for Wound Healing
Description

The purpose of this research study is to learn about a new device, Autologous Regeneration of Tissue (ART), for collecting skin grafts from participant's own skin.

Conditions

Wound of Skin

Efficacy and Safety of 0.25% Timolol Gel in Enhancing Full Thickness Skin Grafts Healing and Cosmetic Outcomes
Description

The use of topical beta-blockers, such as 0.25% timolol, in promoting wound healing is currently emerging in the academic literature. The investigators will enroll 82 patients who have their skin cancer surgically removed resulting in the need of a full-thickness skin graft. The objective of this randomized safety study is to determine the safety and efficacy of 0.25% timolol in promoting wound healing in full-thickness skin grafts compared to standard of care.

Conditions

Wound of Skin, Wound Heal, Surgical Wound, Full Thickness Skin Graft Healing

Efficacy and Safety of a Nanofat-seeded Biological Scaffold in Healing Lower Limb Surgical Defects
Description

Large full-thickness skin defects, such as those resulting from trauma, large and giant congenital nevi, disfiguring scars, or tumor resection remain major clinical problems to patients and physicians. Skin flaps and grafts represent the current standard of care (SOC), but often present limitations associated with surgical morbidity and donor site availability. The investigators will enroll 64 patients who have their skin cancer surgically removed and require reconstructive procedure such as a skin flap/graft. To objective of this study is to assess the efficacy and safety of a nanofat-seeded biological scaffold versus the SOC in healing larger surgical defects (\>1.5cm) involving the lower limb that cannot be closed by direct suture and thus need a reconstructive procedure such as a skin flap/graft.

Conditions

Wound of Skin, Non-melanoma Skin Cancer, Skin Graft Complications, Wound of Lower Leg, Wound of Knee

Topical Collagen Powder for Healing of Acute Full-thickness Wounds
Description

We have designed a pilot study to investigate the effect and potential utility of topical NuvagenTM (collagen powder) on the rate and quality of wound healing in healthy volunteers using the punch biopsy method. After inducing an acute full-thickness wound, the rate of complete healing of a wound treated with topical NuvagenTM (collagen powder) will be compared to the rate of complete healing of a wound treated with primary closure with sutures, the current gold standard. Qualification and semi-quantification of histologic and immunohistochemical markers will be used to assess the maturity and structural stability of the wound bed. Positive findings would suggest that NuvagenTM (collagen powder) may be capable of stimulating the healing of acute wounds in a similar or even superior manner to primary closure, suggesting collagen powder may be used in place of sutures, and encouraging further studies to characterize its therapeutic potential in dermatologic surgery.

Conditions

Wound of Skin, Wound Heal

Efficacy and Safety of 0.25% Timolol Gel in Healing Surgical Open Wounds
Description

The use of topical beta-blockers, such as 0.25% timolol, in promoting wound healing is currently emerging in the academic literature. The investigators will enroll 114 patients who have their skin cancer surgically removed resulting in open surgical wounds less or equal to 1.5 cm. The objective of this randomized safety study is to determine the safety and efficacy of 0.25% timolol in promoting wound healing in open surgical wounds less or equal to 1.5 cm.

Conditions

Wound of Skin, Wound Heal, Wound Open, Surgical Wound

Reducing Surgical Site Infection Rates Using an Alternative Sternal Dressing
Description

This study will evaluate two alternative dressings compared to a standard Island dressing presently in use at Stanford Hospital to determine reductions in surgical site infection (SSI) rates among cardiac surgery patients. Cardiovascular surgery patients who will have a sternotomy incision as a routine part of their surgery will be approached to voluntarily participate. Participants will be randomized to one of three dressing to determine which dressing has the lowest rate of sternal wound infection. The investigators will also assess the impact of alternative dressing use on hospital 30-day readmission rates related to SSI.

Conditions

Wound of Skin

Study of Skin and Muscle Parameters Using a Skin Sensor
Description

The aim of this study is to assess the role of skin sensors in obtaining reliable and accurate serial measurements of skin parameters in the context of cutaneous skin wound healing.

Conditions

Skin Wounds

Deep Tissue Injury Treatment With MIST Therapy Versus Standard Care: REVERSE DTI Study
Description

The purpose of this study is to evaluate the effectiveness of MIST Therapy in conjunction with standard of care (SOC) compared to SOC alone in the prevention of deep tissue injury (DTI) progression to advanced stage pressure ulcers.

Conditions

Wound of Skin

StrataGraft® Skin Tissue as an Alternative to Autografting Deep Partial-Thickness Burns
Description

The proposed study is designed as a phase Ib open-label, dose-escalation, multicenter study evaluating the safety, tolerability, and efficacy of StrataGraft skin tissue in promoting the healing of the deep partial-thickness component of complex skin defects. The proposed study population will include patients with 3-49% Total Body Surface Area (TBSA) complex skin defects including a deep partial-thickness component resulting from thermal injury. The study has been designed to focus on the evaluation of safety and tolerability of prolonged exposure to increasing amounts of a single application of StrataGraft skin tissue, while also assessing the potential for StrataGraft tissue to promote healing of the deep partial-thickness component of these complex skin defects as an alternative to donor site harvesting and autografting. Targeted enrollment for this study is up to 30 patients with complex skin defects due to thermal burns which require surgical excision and autografting. Subjects will be sequentially enrolled in two cohorts of increasing treatment area receiving StrataGraft skin tissue that has been stored refrigerated prior to clinical use. A third cohort will receive StrataGraft skin tissue which has been stored cryopreserved and thawed in the operating room just prior to grafting.

Conditions

Skin Wound, Burns, Trauma-related Wound

Scar Appearance After Postoperative Hydrocolloid Dressing Versus Standard Petrolatum Ointment
Description

Patients will be randomized either to receive standard daily dressing or hydrocolloid dressing using a randomization generator. After closing the wound with the sutures,the scar will be covered by a hydrocolloid dressing, which will be left in place for 7 days(Experimental) or the standard dressing (Control) that will be covered with petrolatum jelly and bandaging during this time period, which has to be re-applied daily. Patients and dermatologic surgeons will then complete surveys 7 days, 30 days, and 90 days after surgery to evaluate the cosmetic appearance of these scars.

Conditions

Scar, Skin Scarring, Skin Cancer, Wound Heal, Wound of Skin, Surgical Wound, Patient Satisfaction, Patient Preference, Surgical Incision

A Clinical Investigation to Follow the Progress of Exuding Chronic Venous Leg Ulcers Using a Non-Bordered Foam Dressing
Description

The goal of this clinical trial to follow the progress of wounds in those with chronic venous leg ulcers while using a non-bordered foam dressing. The main objective is to follow the progress of these wounds over time from initial visit to each follow-up visit. Participants will be asked to wear the dressing for up to 6 weeks of treatment or until healed, changed at every one-week interval.

Conditions

Wounds, Wound of Skin, Wound Leg, Venous Leg Ulcer

A Clinical Investigation to Follow the Progress of Exuding Chronic Wounds Using Mepilex® Up as the Primary Dressing.
Description

The goal of this clinical trial is to follow the progress of wounds in those with venous leg ulcers and diabetic foot ulcers while using an absorbent dressing called Mepilex Up. The main objective is to follow the progress of these wounds over time from initial visit to each follow-up visit. Participants will be asked to wear Mepilex Up dressing for up to 6 weeks of treatment or until healed, changed at every one-week interval.

Conditions

Wounds, Wound of Skin, Wound Leg, Wound; Foot, Diabetic Foot Ulcer, Venous Leg Ulcer

Limb Health and Socket Pressure in Response to Powered Ankle Protheses
Description

this project seeks to understand and quantify the effects of powered transtibial prostheses on socket loading and direct measures of residual limb health so as to inform the optimization of prosthesis fit.

Conditions

Pressure Ulcer, Ankle, Prosthesis User, Prosthesis Durability, Mobility Limitation, Skin Wound, Amputation; Traumatic, Foot, Amputation, Limb Deficiencies

Influence of Sun Protection and Linear Repair of Cutaneous Surgical Defects
Description

The purpose of this study is to determine the potential influence of sun protection on the aesthetic outcome of post-surgical scars following the reconstruction of Mohs micrographic surgery defects via linear repair. This study will be performed as a randomized split-wound study. Half of the wound will be treated with zinc containing sunscreen and the other half of the wound would not be treated. Three-months post-surgery, the scar will be evaluated via the patient observer scar assessment scale (POSAS), a validated scar instrument, as well as a colorimeter to measure the amount of vascularity, and hyperpigmentation between the treated and the non-treated area compared to the 'surrounding skin' defined as skin in the proximity but not adjacent to the wound. Any adverse events will also be recorded.

Conditions

Surgical Wound, Wound Heal, Wound of Skin, Scar

Aesthetic Outcome of Complex Linear Closure vs Second Intention Healing: Below the Knee
Description

The purpose of this study is to determine whether complex linear closure vs second intention healing for cutaneous wounds below the knee affects esthetic outcomes (primary outcome). As secondary outcome, the study team plans to look at patient quality of life measures and complications. This will be a prospective, 2-arm, randomized, evaluator-blinded clinical trial. One half of the patients will receive repair by complex linear closure and the other half of the patients will undergo second intention healing. Three-months post-surgery, the scar will be evaluated via the patient observer scar assessment scale (POSAS), a validated scar instrument, as well as the trace-to-tape method, an objective outcome measure for linear postoperative scars. In addition, patients will be provided a validated quality of life survey to complete. Any adverse events will also be recorded.

Conditions

Wound Heal, Wound of Skin

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

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.

Conditions

Laceration, Skin Wound, Wound Heal