Treatment Trials

110 Clinical Trials for Various Conditions

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RECRUITING
Acellular Collagen Matrix As a Tool to Obtain Wound Closure Following a Guided Bone Regeneration Procedure
Description

Guided bone regeneration (GBR) is a procedure used to increase the amount of bone volume in the jaw before placing a dental implant. It is needed when a lot of bone has been lost around the spot where a tooth has been lost or extracted. An incision is made, bone grafting material is placed in that spot, there is a membrane put over it as a barrier, then gum tissue has to be pulled back over it. Usually, this is enough to cover the whole wound, but sometimes the barrier membrane can't be covered with tissue the whole way without too much pulling, and the barrier membrane is still exposed. In that case, one thing that can be done is to place another material, an acellular collagen matrix, over the barrier membrane and secure it there. This material has been shown to help with the healing in these cases. Participants in this study will be clinic patients who have been determined to need a GBR procedure. Participants will get the GBR. If the barrier membrane is still exposed, then the acellular matrix material will be placed. This study will compare the healing outcomes and the success of the GBR depending on whether the acellular matrix material was used. The procedure itself is not part of the study. The only people in the study are patients who are already planning to have this procedure done as part of their dental care. It is important to note that the research study will not affect the care that the patient is given, or whether or not the acellular matrix material is used. That will be decided by the dental surgeon who is treating them, based on their clinical judgement. The research study will only observe and compare the outcomes. For the study, participants will have some additional clinical measurements made, besides the ones that are done as part of the follow-up care, and will be asked questions about their experience.

Conditions
RECRUITING
Suture Versus Staples for Wound Closure in Orthopaedic Trauma Surgery
Description

This pilot study is designed to assess the feasibility of comparing skin closure methods - sutures versus staples - and subsequent rates of surgical site infection following open reduction and internal fixation surgery for orthopaedic trauma injuries. The primary objectives are to determine if enrollment, randomization, and compliance are feasible and to refine data collection methods. Patients =18 years of age with closed fractures of the tibial plateau, tibial pilon, patella, and distal femur presenting within 3 weeks of injury undergoing definitive treatment of their fracture will be approached for participation. If enrolled, they will be randomized to having their surgical wound closed with either nylon sutures or metallic staples. Patient follow up will be standard of care besides answering PROMIS surveys.

RECRUITING
Safety and Efficacy of realSKIN® to Provide Complete Wound Closure of Burn Wounds as an Alternative to Autografting
Description

To evaluate the safety and efficacy of realSKIN® to provide complete wound closure of mixed-depth, full-thickness burn wounds as an alternative treatment to autografting.

ACTIVE_NOT_RECRUITING
Clinical Study Evaluating Wound Closure With Endoform™ and Symphony™
Description

Study will evaluate the performance and safety of Endoform™ Natural and Endoform™ Antimicrobial in conjunction with Symphony™ in the treatment of chronic non-healing diabetic foot ulcers after 12 weeks of treatment.

WITHDRAWN
Brijjit® for Wound Closure in Gender Affirming Mastectomies
Description

This study will evaluate the use of Brijjit® for wound closure in individuals undergoing bilateral double incision gender affirming mastectomies with a single surgeon (Rachel Bluebond-Langner, MD). The study will be a randomized prospective interventional study utilizing internal controls (one side of chest receives intervention, other serves as control). Primary endpoints will include scar appearance/quality and wound complications

Conditions
COMPLETED
Orthopaedic Surgical Wound Closure Comparison Study
Description

This study is trying to find out if there is one method of surgical incision closure is better than another. The three different wound closure methods in this study are currently used in standard of care. The three methods being compared are standard stitches and the wound closure devices, Clozex, and Zipline. All of these methods are approved by the FDA.

RECRUITING
A Clinical Investigation Evaluating Wound Closure With OptiPulse™ Versus SOC in the Treatment of Non-Healing DFU's
Description

The purpose of this clinical investigation is to assess the safety and performance of Compedica's OptiPulse™ and to collect subject outcome data on the treatment of diabetic foot ulcers (DFU's) versus the standard of care (SOC). OptiPulse™ is designed to enhance blood circulation in the venules and arterioles. Fibracol Plus (or equivalent) is a collagen alginate dressing that is used as the primary dressing. Both products are 510(k) FDA cleared and will be used within the cleared intended use.

COMPLETED
Comparison of Cosmetic Outcomes of Straight Line and W-plasty Techniques for Linear Wound Closure
Description

The purpose of this study is to compare the cosmetic outcome of traditional straight-line (SL) linear closure to that of W plasty (a type of geometric broken-line cutaneous closure technique) for closure of post-auricular wounds resulting from harvest of full thickness skin grafts during Mohs micrographic surgery. The research team will use a split wound model, where half of the wound is repaired with a straight-line cutaneous closure and the other half is repaired with the W-plasty technique. Three-months post-surgery, the scar will be measured via the patient observer scar assessment scale (POSAS), a validated scar instrument. The scar width, and adverse events will also be recorded.

TERMINATED
Assessment of Wound Closure Comparing Synthetic Hybrid-Scale Fiber Matrix With Standard of Care in Treating Diabetic Foot Ulcers (DFU) and With Living Cellular Skin Substitute in Treating Venous Leg Ulcers (VLU)
Description

In participants with diabetic foot ulcers (DFUs), this study will assess complete wound closure by comparing synthetic hybrid-scale fiber matrix (Restrata®) with standard of care. In participants with venous leg ulcers (VLUs), this study will assess complete wound closure by comparing synthetic hybrid-scale fiber matrix (Restrata®) with living cellular skin substitute (Apligraf®)

TERMINATED
Celliant Socks to Increase Tissue Oxygenation and Complete Wound Closure in Diabetic Foot Wounds
Description

This study is a prospective, multicenter, double-blind, 1:1 randomized clinical trial. The purpose of this study is to demonstrate that the use of Celliant Socks increases tissue oxygenation (via oxygen saturation, StO2) and incidence of wound closure in subjects with diabetic foot ulcers. This study will use hyperspectral imaging and wound assessment to measure these outcomes. The study will enroll 254 evaluable subjects total, 127 per arm to meet the Primary Endpoint. Enrollment may continue up to twenty-five hundred (2500) evaluable subjects total to meet the Key Secondary Endpoint of complete wound closure.

RECRUITING
Wound Closure Techniques in Primary Spine Surgery
Description

The Researchers are trying to determine if there is a difference in blood flow around a wound site when comparing three different types of wound closure techniques.

Conditions
TERMINATED
Does Addition of a Vessel Loop in Wound Closure Improve Suture Removal?
Description

This study will investigate whether adding a vessel loop under sutures after elective carpal tunnel release increases patient satisfaction with suture removal.

TERMINATED
Secondary Versus Tertiary Wound Closure in High Risk Gynecologic Abdominal Surgical Incisions
Description

The purpose of this research study is to determine if closing a surgical wound differently is better than the procedure that is currently used. The wound will be closed with what is considered "tertiary intent." This means, rather than leaving the wound open, the wound will be partially closed after surgery, and then completely closed 4-7 days after surgery. The investigators also want to see how this new wound closure process affects your quality of life.

RECRUITING
Wound Closure Study in Carpal Tunnel and Trigger Finger Surgery
Description

Does a difference in patient satisfaction and cosmetic outcome exist between wound closure with absorbable or non-absorbable sutures.

UNKNOWN
A Post-Market Study of BandGrip in Traumatic Wound Closure Compared to Suture
Description

an unbalanced (2:1) randomized study comparing two methods of traumatic skin closure in an ER setting: BandGrip vs suture

COMPLETED
Interrupted Subdermal Suture Spacing During Linear Wound Closures and the Effect on Wound Cosmesis
Description

This study aims to investigate whether the spacing of the interrupted deep (subdermal) sutures affects surgical wound cosmesis on the trunk and extremities. In other words, the investigator would like to determine which of the following yields a more cosmetically appealing scar: many closely approximated subdermal sutures or fewer, more widely spaced subdermal sutures. The investigator wishes to compare the effects of one versus two centimeter spacing between sutures.

ACTIVE_NOT_RECRUITING
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.

COMPLETED
A Study Investigating the Efficacy of Various Wound Closure Devices in Reducing Postoperative Wound Complications
Description

A single-center, phase IV, randomized, prospective study investigating the efficacy of various wound closure devices in reducing postoperative wound complications.

COMPLETED
Cesarean Wound Closure in Women With BMI 40 or Greater
Description

The purpose of this randomized controlled prospective trial is to guide physicians on the most effective evidenced based skin closure during a cesarean section for the obese gravida, defined as a BMI of 40 or greater. The study will compare two closure methods: subcuticular sutures and surgical staples.

COMPLETED
Perfusion Assessment of Wound Closure Techniques in Primary Total Knee Arthroplasty
Description

This study will assess which of the three most common methods of wound closure in primary total knee arthroplasty (staples, interrupted vertical mattress, or running subcuticular suture) provide the best wound vascular perfusion. This can be achieve by using SPY intra-operative vascular angiography, which is commonly used in clinical practice to assess perfusion of wound closure at the clinic. By understanding the differences in perfusion afforded by different closure techniques, surgeons will then be able to select the technique that optimizes this parameter so as to avoid complications such as tissue necrosis, wound dehiscence, or infection.

COMPLETED
Clinical Trial Comparing Standard Wound Closure Techniques Versus TissuGlu® Surgical Adhesive
Description

The purpose of this study is to determine if TissuGlu® Surgical Adhesive is safe and effective alternative to drains(standard of care) for fluid management following abdominoplasty. It is hypothesized that the use of the Cohera device will facilitate reduction or closure of dead space when applied to planar surfaces created during an abdominoplasty procedure.

UNKNOWN
Effectiveness of Wound Closure Using V-Loc™ 90 Sutures in Lipoabdominoplasty Patients
Description

VLock suture studied in abdominal wound closure. Time and cosmesis was studied

COMPLETED
Assessment of Severe Extremity Wound Bioburden at the Time of Definitive Wound Closure or Coverage
Description

The purpose of this study is to characterize the bacteria in the wound "bioburden" at the time of definitive wound coverage/closure of severe tibia fractures in both the military and civilian populations.

Conditions
COMPLETED
Dispervise Ophthalmic Viscoelastic as an Agent to Ensure Watertight Wound Closure After Clear Corneal Cataract Incisions
Description

The purpose of this study is to look at the ability of Viscoat to ensure proper wound closure.

Conditions
TERMINATED
Staples Versus Suture for Cesarean Wound Closure
Description

The objective of this randomized controlled trial is to compare wound morbidity (including disruption and infection) in surgical staples versus absorbable subcuticular suture for wound closure in cesarean deliveries.

Conditions
UNKNOWN
The Effects of Fractional Carbon Dioxide (CO2) Laser Treatment Prior to Wound Closure
Description

The purpose of this study is to determine if fractional carbon dioxide laser treatment of a fresh wound at the time of surgery, decreases scar formation. Scar revision is commonly done at 6-10 weeks following surgery. Therefore, it may be more beneficial, for both the patient and physician, to perform scar revision at the time of surgery.

Conditions
COMPLETED
Study to Show Equivalence of DERMABOND PROTAPE to DERMABOND HVD for Wound Closure
Description

This is a multicenter, prospective, randomized controlled study for the purpose of comparing DERMABOND PROTAPE to DERMABOND HVD for closure of wounds in the Emergency Department. The objective of this study is to demonstrate whether the incidence of wound closure for DERMABOND PROTAPE is equivalent to that measured for DERMABOND HVD.

Conditions
TERMINATED
Comparison Study of Wound Closure at Time of Cesarean Delivery: Dermabond Glue Versus Surgical Staples
Description

Women who have a cesarean delivery have a surgical incision on their abdomen (belly). The usual way to close this opening is with metal surgical staples. In many other types of surgery, surgical incisions are closed with a super-glue called Dermabond. The researchers at the University of Massachusetts believe Dermabond may be a safe alternative to using staples at the time of a cesarean delivery, but this has not been studied. Women who choose to participate will be randomly assigned to have the cesarean delivery skin incision closed with staples or Dermabond. The researchers will survey the patients to see how they felt about the experience and the appearance of their scar. The researchers will survey physicians performing the surgery to see how easy Dermabond was to use. The researchers will ask physicians to evaluate the appearance of the incision after a 6-week recovery period and will analyze complications (such as bruising, infection, or separation of the wound) in the two groups.

UNKNOWN
Wound Closure Techniques
Description

A Comparison of Skin Closure Techniques after Primary Cesarean Delivery. Traci N. Gray, M.D. and Peter F. Schnatz, D.O. A prospective, observer blinded, randomized, and controlled trial comparing Dermabond closure technique to suture closure of skin. Study Participants: All women age 18years or older who provide informed consent prior to primary Cesarean delivery at Hartford Hospital. Women with vertical skin incisions and or who are febrile preop or intraop will be excluded. Methods: Qualified participants will then be randomized to skin closure with either Dermabond or suture. Surgeon preference will dictate usage of 4-0 monocryl or 4-0 vicryl for skin closure for patients randomized to the suture arm. * The circulating nurse will time all skin closures. * The surgeon will complete a 3 question survey immediately postop. * At the 6 week post partum visit, patients and the health care professional will complete a brief query regarding cosmetic appeal and pain. A disposable camera will be supplied to each provider office and a photo will be taken of the incision. * All photos will be evaluated for cosmesis by physicians who will be blinded to the methods of skin closure. Primary Outcomes: To compare the time needed to close skin. To compare cosmetic outcome after healing Secondary Outcomes: Patient Pain scores. Provider and patient satisfaction. Responses to questions.

Conditions
COMPLETED
Evaluation of Purse-String Closure Vs Second Intention
Description

To compare healing time, scar size, aesthetic outcome, and complication rates following second intention healing or purse string closure of surgical wounds on the trunk or extremities. This study, will allow surgeons to make informed decisions on whether purse string closure is superior to that of second intention healing and thus worth considering or inferior and not worth performing.