Treatment Trials

168 Clinical Trials for Various Conditions

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COMPLETED
Skin Glue Versus Suture for Securing Radial Arterial Lines
Description

Prior investigators have evaluated the use of 2-octyl cyanoacrylate (glue) as a method to secure a variety of venous catheters including central/peripheral lines. There is a paucity of research evaluating the use of glue for arterial catheters. The investigators conducted a pilot study to test the null hypothesis that there would be no difference in failure rates between radial arterial lines (r-a-line) secured with glue vs. suture.

NOT_YET_RECRUITING
Patient Satisfaction and Cosmetic Outcomes in Adhesive Strip Versus Suture Repair for Simple Facial Lacerations
Description

There are a variety of techniques utilized to close lacerations, including but not limited to, traditional sutures, staples, adhesive strips, and skin glue. While closing open wounds and preventing infection are the primary goals of laceration repair, physicians are also concerned with minimizing scar formation and providing the best cosmetic outcomes for the patient. Specifically, the skin on the face is a sensitive area where cosmetic outcome is of high importance, and several laceration repair techniques have been devised for closing facial wounds. Sutures have traditionally been used to close wounds in various types of tissue, and it is still very commonly used in the clinical setting. Adhesive strips (also known under the brand names of Steri-Strips, Curi-strips, Nichi-Strips, and Suture Strips) are another method to repair lacerations superficially. Due to their superficial application and ease of use, adhesive strips may help minimize scar formation and may result in less pain and complications for the patient when compared to conventional sutures. Therefore, the aim of this study is to determine whether repair of small, simple facial lacerations with adhesive strips results in better patient experiences and better cosmetic outcomes than sutures. The investigators hypothesize that wounds repaired with adhesive strip will have higher patient satisfaction scores and better cosmetic outcomes.

COMPLETED
To Show the Safety and Effectiveness of the Demetech Barbed Polydioxanone (PDO) Suture
Description

The clinical trial, sponsored by Sutura Medical Technology, Inc., is a pivotal, blinded, multi-center study assessing the safety and effectiveness of the Demetech Barbed PDO Suture, an absorbable Polydioxanone suture, for the temporary treatment of midface wrinkles. The trial will enroll 57 subjects across up to four sites, following them over a 12-month period to evaluate improvements in wrinkles based on the Lemperle Classification Facial Wrinkle Scale. Primary endpoints include assessing the rate of adverse events and a significant reduction in wrinkle severity at 6 months, with secondary endpoints focusing on longer-term results and patient satisfaction.

Conditions
COMPLETED
Sutures for Treatment of Knee Arthroscopy
Description

For a knee arthroscopy, two small incisions are made at the level of the joint line on each side of the patellar tendon. Closure of surgical incisions consists of using either nonabsorbable or absorbable sutures. Some surgeons prefer using nonabsorbable sutures due to it being easier to tie, these sutures are less likely to break prematurely, and that they elicit a minimal inflammatory response. On the other hand, some surgeons prefer using absorbable sutures due to the time savings of not having to remove the sutures at a later date and that these sutures decrease patient anxiety and discomfort. The purpose of this study is to prospectively investigate and compare patient's pain, swelling and cosmesis following knee arthroscopy surgery between patients who had their arthroscopy portals closed using resorbable sutures vs. patients who had their portals closed using nonabsorbable sutures.

ACTIVE_NOT_RECRUITING
Suture Closure Trial
Description

Closure of surgical incisions in orthopedic procedures contributes to patient postoperative pain and risk of complication. As the focus on improving orthopedic surgery outcomes shifts to best practices in postoperative pain management, it is important to consider suture types and techniques. This study specifically would focus on comparing different suture types and techniques and their efficacy. This will be a randomized controlled trial comparing currently used, standard of care suture types and currently used, standard of care suture techniques to identify differences, if any exist, in postoperative pain scores and wound healing as assessed by exam and postoperative patient surveys. Patients will be identified by the Emory Upper Extremity/Hand Surgeons as they are identified as a candidate for surgery. Participants will then be informed of the study and spoken to about the specifics of the study. The research team will consent and recruit patients either in The Emory Clinic or in the preoperative area prior to surgery. All surgical operations will take place at the ambulatory surgical center in The Emory Clinic or at the Emory University Orthopaedic and Spine Hospital. Patients will not be compensated for participation in this study. No specimens/data/samples will be collected and stored for later use, and there are no optional substudies. This proposed study will address the lack of published literature regarding the suture technique in hand and wrist surgery in particular. Combined with examining various suture materials, the proposal has the potential to provide a valuable and actionable base of knowledge to the current body of literature.

COMPLETED
Evaluation of a Novel Sutureless Drain Securement Device
Description

The purpose of this study is to evaluate an investigational sutureless drain securement device (K-Lock) and compare this device to standard drain securement.

Conditions
COMPLETED
Aesthetic Outcome of Running Cuticular Suture Distance (2mm vs 5mm)
Description

It is standard teaching that the top layer of sutures should be placed 3-5mm from the wound edge. However, there is lack of data regarding the most optimal placement of sutures from the wound edge for the best cosmetic outcome. The research team wish to determine if sutures placed closer to the wound edge (2mm) or farther from the wound edge (5mm) makes a difference in the cosmetic outcome of the scar.

COMPLETED
A Comparison of the Effect of Suture Material on Blepharoplasty Incision
Description

The objective is to compare the effect of suture material on blepharoplasty incision. Outcomes of blepharoplasty scar and/or cosmesis will be compared between plain gut and polypropylene suture. Additionally, the study will assess whether certain Fitzpatrick skin types are associated with increased rates of poor outcomes after blepharoplasty.

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.

RECRUITING
Vicryl Rapide Versus Nonabsorbable Suture
Description

This will be a prospective, randomized controlled trial assessing noninferiority of Vicryl Rapide compared to nonabsorbable suture. The study will be conducted in the Community Regional Medical Center emergency department (ED). The aim of this study, then, is to prospectively determine if 3-month cosmesis for traumatic laceration repair of trunk/extremity lacerations in adult patients with Vicryl Rapide is noninferior to nonabsorbable suture.

TERMINATED
Effect of Replacing Buried Sutures With Tissue Adhesive on Aesthetic Outcome of Surgical Wounds.
Description

Surgery wounds are typically closed with combination of absorbable stitches placed under the skin and non-absorbable stitched placed at the skin surface. Absorbable sutures can produce unwanted side effects when the body produces a reaction to them. The investigators are conducting a study to determine if absorbable stitches can be replaced but tissue glue applied on the surface of the skin. If participants enroll in the study, the investigators will close one half of the participants wound with absorbable stitches placed under the skin and non-absorbable stitches on the surface. The other half of the wound will be closed with non-absorbable stitches and tissue glue. The appearance of the scar (if any) will then be evaluated at 3- and 6-month follow-ups by two dermatologists (either board-certified dermatologists or dermatology residents) and the patient.

Conditions
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.

COMPLETED
Wound Vac Polypropylene Suture Pilot Study
Description

You are being asked to participate in this study because you have a complex wound that requires treatment with negative pressure wound therapy (NPWT). NPWT is a therapeutic technique which involves the placement of a wound vacuum at the site of the wound. The wound vacuum delivers a negative pressure at the wound site through a dressing. Any fluid collected during this process is collected through a foam (sponge) underneath the dressing. This therapy helps to draw the edges of the wound together, while removing infectious material, to help promote healthy tissue growth and speed up wound healing. The purpose of this study is to determine if placing polypropylene suture (a material normally used to close wounds) between the wound and the NPWT foam would decrease pain upon removal of the sponge while allowing adequate healing of the wound.

Conditions
COMPLETED
ZIPS Study - Zip Incision aPproximation vs. Suture
Description

ZipLine Medical, Inc. has developed a novel, non-invasive skin closure device called "Zip Surgical Skin Closure" to replace sutures, staples and glue for closure of the skin layer for surgical incisions or laceration repair. The study will be comparing the Zip Surgical Skin Closure to standard sutures in patients undergoing cardiovascular implantable electronic device (CIED) procedures on outcomes including closure time, cosmetic appearance of resulting scar, and overall cosmetic appearance of scar. The study will be following participants for 3 months following CIED procedure.

TERMINATED
Cosmetic Outcome Study of Lid Laceration Repair With Suture Versus Tissue Adhesive
Description

This project is a randomized, controlled trial investigating wound cosmetic appearance after repair of traumatic lid lacerations with three different approaches to skin closure: absorbable sutures, non-absorbable sutures, and tissue adhesive. Photographs will be taken at two intervals after repair and later blindly assessed using standard cosmetic assessment scales. The investigators hypothesize that cosmetic wound outcome will be equivalent in across all three treatment arms.

UNKNOWN
Vaginal Cuff Closure Time Using Unidirectional Barbed Suture in Robotic Hysterectomy
Description

This study is designed to determine if using the V-Loc Wound Closure System expedites operative time in robotic hysterectomy.

UNKNOWN
Affixing Polypropylene Mesh Using Barbed Suture (Quill™ SRS) During Robotic Assisted Laparoscopic Sacrocolpopexy
Description

1.0 STUDY OBJECTIVE 1.1 PRIMARY OBJECTIVE - To compare two methods of polypropylene mesh attachment during robotic assisted laparoscopic sacrocolpopexy (RALSC): running technique using self-anchoring 1 barbed delayed absorbable suture (Quill™ SRS, Angiotech Pharmaceuticals, Inc. Vancouver, Canada) versus interrupted technique using 0 non-barbed delayed absorbable suture (PDS II™, Ethicon, Somerville, NJ, USA). 1.2 SECONDARY OBJECTIVE - To compare robotic assisted laparoscopic sacrocolpopexy anatomic failure rates at 6 months post-operative follow-up using self-anchoring 1 barbed delayed absorbable suture (Quill™ SRS, Angiotech Pharmaceuticals, Inc. Vancouver, Canada) versus 0 non-barbed delayed absorbable suture (PDS II™, Ethicon, Somerville, NJ, USA). The investigators will also assess mesh erosion rates, costs, and surgeon satisfaction rates. 2.0 HYPOTHESIS 2.1 Primary: 2.1.a. Attachment of mesh using the running technique with self-anchoring 1 barbed delayed absorbable suture (Quill™ SRS, Angiotech Pharmaceuticals, Inc. Vancouver, Canada) will be faster than the standard fixation interrupted technique using 0 non-barbed delayed absorbable suture (PDS II™, Ethicon, Somerville, NJ, USA). 2.2 Secondary: 2.2.a. Attachment of mesh using the running technique with self-anchoring 1 barbed delayed absorbable suture (Quill™ SRS, Angiotech Pharmaceuticals, Inc. Vancouver, Canada) will be less costly than the standard fixation interrupted technique using 0 non-barbed delayed absorbable suture (PDS II™, Ethicon, Somerville, NJ, USA). 2.2.b. Failure rates and mesh erosion rates for each technique will be equally low. 2.2.c. Surgeons will prefer the barbed running technique over the interrupted technique based on subjective surgeon satisfaction questionnaires.

Conditions
COMPLETED
Affixing Polypropylene Mesh Using Barbed Suture (Quill™ Srs) During Laparoscopic Sacrocolpopexy Randomized Controlled Trial (Quill Lsc)
Description

1.0 STUDY OBJECTIVE 1.1 PRIMARY OBJECTIVE - To compare two methods of polypropylene mesh attachment during laparoscopic sacrocolpopexy (LSC): running technique using self-anchoring 1 barbed delayed absorbable suture (Quill™ SRS, Angiotech Pharmaceuticals, Inc. Vancouver, Canada) versus interrupted technique using 0 non-barbed delayed absorbable suture (PDS II™, Ethicon, Somerville, NJ, USA). 1.2 SECONDARY OBJECTIVE - To compare laparoscopic sacrocolpopexy anatomic failure rates at 6 months post-operative follow-up using self-anchoring 1 barbed delayed absorbable suture (Quill™ SRS, Angiotech Pharmaceuticals, Inc. Vancouver, Canada) versus 0 non-barbed delayed absorbable suture (PDS II™, Ethicon, Somerville, NJ, USA). The investigators will also assess mesh erosion rates, costs, and surgeon satisfaction rates. 2.0 HYPOTHESIS 2.1 Primary: 2.1.a. Attachment of mesh using the running technique with self-anchoring 1 barbed delayed absorbable suture (Quill™ SRS, Angiotech Pharmaceuticals, Inc. Vancouver, Canada) will be faster than the standard fixation interrupted technique using 0 non-barbed delayed absorbable suture (PDS II™, Ethicon, Somerville, NJ, USA). 2.2 Secondary: 2.2.a. Attachment of mesh using the running technique with self-anchoring 1 barbed delayed absorbable suture (Quill™ SRS, Angiotech Pharmaceuticals, Inc. Vancouver, Canada) will be less costly than the standard fixation interrupted technique using 0 non-barbed delayed absorbable suture (PDS II™, Ethicon, Somerville, NJ, USA). 2.2.b. Failure rates and mesh erosion rates for each technique will be equally low. 2.2.c. Surgeons will prefer the barbed running technique over the interrupted technique based on subjective surgeon satisfaction questionnaires.

Conditions
COMPLETED
Cesarean Trial of Staples vs. Sutures
Description

To determine whether the rate of wound complications differs based on method of closure of skin incision (staples vs. suture) after cesarean delivery.

COMPLETED
Pain and Anxiety Management With Oral Narcotic for Pediatric Suture Repair
Description

The purpose of this study is: * To determine whether oral narcotic medication versus placebo improves the pain and anxiety scores for pediatric patients requiring laceration repair in the pediatric emergency department and receiving the standard of care with lidocaine treatment * To evaluate for a statistical difference in pain scores in children during laceration repair * To evaluate for a statistical difference in State-Trait Anxiety Inventory for Children (STAIC) scores during laceration repair

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
COMPLETED
A Comparison of Monosyn and Monocryl Sutures in Surgical Wounds
Description

To better understand surgeon preference when using synthetic, absorbable, monofilament suture by comparing two similar appearing FDA-approved sutures, Monosyn (Aesculap) and Monocryl (Ethicon).

Conditions
TERMINATED
Comparison of Cyanoacrylate Tissue Adhesive and Suture for Closure of Cardiac Device Pockets
Description

The purpose of this study is to determine whether cyanoacrylate tissue adhesive is as effective as polyglactin 910 suture for surgical closure of cardiac device pockets.

COMPLETED
A Comparison Of The 3M TM S Surgical Skin Closure System To The Standard Vicryl Suture Closure of Sternotomy Incisions During Cardiac Surgery
Description

Following closure of surgical incisions, wounds may develop redness, swelling, and drainage which may result in increased pain and infection. This study will test to hypothesis that using the 3M TM S Surgical Skin Closure System will reduce the incidence of pain, redness, swelling, and infections in a group of patients undergoing a mediastinotomy incision used for open heart surgical procedures.

Conditions
COMPLETED
Study of Sutures Versus Staples for Skin Closure After Surgical Procedures of Hip
Description

Skin closure either by sutures or staples is required after any surgical procedure of the hip. The purpose of this study is to compare the amount of drainage between patients who have had either staples or sutures placed for skin closure.

Conditions
RECRUITING
Evaluation of Laparotomy With Trans-Amniotic Suture Placement in TTTS Surgery
Description

This is a randomized trial for patients that are diagnosed with Twin-Twin Transfusion Syndrome (TTTS) who are receiving a fetoscopic laser surgery to evaluate the effectiveness and safety of a laparotomy closure.

RECRUITING
CLOSM Trial: Groin Closure Using Layered Option for Suture Material
Description

This is a randomized controlled trial comparing groin closure after vascular intervention with Vicryl suture versus PDS (polydioxanone) suture. This will be a single center trail performed at CCF main campus. Patients will be enrolled in a prospective fashion and will be randomized 1:1 to either PDS or Vicryl closure. Patients undergoing bilateral groin exposure will be randomized to receive both closure types to either groin.

RECRUITING
Absorbable vs Non-Absorbable Sutures for Hip Capsular Closure
Description

The study is to prospectively compare absorbable sutures with non-absorbable sutures used for capsular repair during hip arthroscopic procedures. Major outcomes will be measured using three questionnaires ((1) International Hip Outcome Tool-12 (iHOT-12), (2) modified Harris hip score, (3) hip outcome score) in addition to the standard of care set of 9 questionnaires. The other major outcome will be any radiographic heterotrophic ossification at the 6-month follow-up time point.

ENROLLING_BY_INVITATION
Retrospective Study of Suture Tape for Soft Tissue Reconstruction in Patients Suffering From Lateral Ankle Instability
Description

This study is intended to be a retrospective chart review of patients with chronic ankle instability who have undergone a lateral ligament reconstructive procedure for ATFL repair (isolated or non-isolated) with suture tape augmentation. Patients that have been treated at any of the participating institutions that have undergone an ATFL reconstruction with Arthrex InternalBrace augmentation who have postoperative hospital or ASC records of safety and effectiveness as measured by adverse events, potential complications, and potential functional outcomes past the 10-week time point will be included.

RECRUITING
Trapeziectomy and Suture Suspensionplasty for Thumb Carpometacarpal Arthritis - Is In-Clinic Therapy Needed?
Description

The study is a randomized, controlled trial to evaluate the efficacy of formal occupational therapy on outcomes following CMC arthroplasty