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Wound Complication clinical trials

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NCT ID: NCT06337292 Not yet recruiting - Wound Heal Clinical Trials

Incisional Negative Pressure Wound Therapy to Reduce Infection and Complications in High-Risk Fractures: A Multicenter Randomized Controlled Trial

iVAC
Start date: May 1, 2024
Phase: Phase 3
Study type: Interventional

This is a multi-center, pragmatic, parallel arm randomized controlled trial (RCT) of 352 patients with high-risk open or closed tibial plateau fracture, high-risk open or closed tibial pilon fracture, or open tibial shaft fracture with incision >3cm. Eligible participants will be randomized to receive either incisional negative pressure wound therapy (NPWT) or a non-suction standard-of-care wound dressing for their definitive wound management. The primary outcome will be a composite outcome to evaluate clinical status 3 months after randomization. The secondary outcomes will independently assess the components of the primary outcome.

NCT ID: NCT06191159 Not yet recruiting - Clinical trials for Postoperative Complications

Cosmetic Outcome of Electrocautery, Scalpel and PEAK PlasmaBlade for Surgical Breast Incisions

SCPPB
Start date: May 2024
Phase: N/A
Study type: Interventional

This study will compare the cosmetic scar result from the use of scalpel, electrocautery, and pulsed electron avalanche knife (PEAK) PlasmaBlade (PPB) for the initial skin incision for total mastectomy procedures without immediate breast reconstruction. It is hypothesized that there will be no significant difference in mastectomy scar cosmesis. The purpose and objectives of this study are: 1. To evaluate and compare the cosmetic scar result from the use of scalpel, standard electrocautery, or PEAK PlasmaBlade for initial incision for total mastectomy procedures without immediate breast reconstruction. 2. To inform future equipment choices for breast surgery including potential elimination of scalpels and their attendant risks.

NCT ID: NCT06063694 Not yet recruiting - Amputation Clinical Trials

Comparing Wound Complication Following TMA With Aid of Electrospun Fiber Matrix

Start date: March 2024
Phase: N/A
Study type: Interventional

Transmetatarsal amputation (TMA) patient populations commonly have poor healing outcomes and a large number of complications. There has been little study on the benefits of augmenting a TMA with a synthetic graft substitute. The long term goal is to push for an application of synthetic graft substitute to reduce infection rates and aid in the healing process. Augmenting a TMA with a synthetic electrospun fiber matrix will demonstrate utilization of the product and other comparators in generating wound healing and infection rate outcomes including rate of infection, wound dehiscence and total healing response. Electrospun fiber matrices have long been investigated as an innovative construct for use in tissue engineering and regenerative medicine research due to their ability to mimic the structure and scale of native tissue. Clinical studies have demonstrated clinical efficacy in treating both chronic and acute wounds. There is strong evidence to support the application of a synthetic electrospun fiber matrix will generate favorable wound healing and reduce infection rates.

NCT ID: NCT05600153 Not yet recruiting - Clinical trials for Breast Reconstruction

Axillary Versus Primary Breast Approach for Second-stage Breast Reconstruction

AvBSR
Start date: December 2022
Phase: N/A
Study type: Interventional

The goal of this clinical trial is to compare the safety of axillary or primary breast approach for second-stage operation in expander-implant breast reconstruction for breast cancer patients. The main question it aims to answer are: 1. if the wound related events, including wound dehiscence, infection, delayed healing is significant less often in patients receiving second stage operation via axillary approach compared with primary breast approach; 2. if the aesthetic outcome is comparable between patients receiving different approach for second stage operation. To answer these questions, the breast cancer patients have received nipple-sparing or skin-sparing mastectomy and had breast tissue expander insertion via breast incision, will be prospectively recruited, and randomized into two groups while receiving implant exchange operation: (1) operate via axillary incision; (2) operate via primary breast incision.

NCT ID: NCT04360603 Not yet recruiting - High Myopia Clinical Trials

The Safety Outcomes of 27 Gauge Vitrectomy for Posterior Segment Disease in High Myopia

Start date: April 2020
Phase: N/A
Study type: Interventional

In recent decade, a major improvement in vitreoretinal surgery was the use of small gauge surgical systems that improved the safety of vitrectomy and also reduced the surgical time. However, there were still some concerns regarding small gauge vitrectomy system, especially 27-gauge system, in the stability of its instruments and the efficacy of removing vitreous during surgery. Although there were some studies that had reported the surgical outcomes of 27G vitrectomy system, none had focused on patients with high myopia. The highly myopic patients usually had thinner sclera, which was a risk factor for wound leakage after sutureless vitrectomy, they also had longer axial length which would make the surgical procedure more difficult especially in macular surgery. Based on previous clinical finding, gas leakage was 36.4% in 25G , while 27G sclerotomy showing less leakage comparing to larger gauge sclerotomy, the investigators believe 27G may have its clinical advantages in overcoming the thinner sclera of high myopia, and show the superiority of leakage control. Hypothesis: The 27G vitrectomy system has lower sclerotomy wound leakage rate compared with 25G system

NCT ID: NCT04214236 Not yet recruiting - Obesity Clinical Trials

CiNPT for Abdominoplasties in Post-bariatric Patients Study

CAPS
Start date: February 1, 2020
Phase: N/A
Study type: Interventional

The overarching goal of this research is to assess whether the post-operative use of closed-incision Negative Pressure Therapy (ciNPT) accelerates healing of surgical wounds, improves surgical outcomes, and reduces the rate of local complications in high-risk, obese, post-bariatric patients undergoing abdominal body-contouring procedures (abdominal panniculectomy or "abdominoplasty") compared to standard wound care. The investigators postulate that ciNPT can cost-effectively improve outcomes and standard of post-surgical care in this specific category of patients. This hypothesis will be tested through a prospective, interventional, case-control, randomized clinical trial.

NCT ID: NCT03872544 Not yet recruiting - Wounds and Injuries Clinical Trials

Short Term Status of Free Dermal Fat Autografts for Complex Craniofacial Wounds

FTFDT3
Start date: September 20, 2023
Phase:
Study type: Observational

This study will evaluate the use of free autologous dermal fat grafting (also called free dermal fat autografting) to treat complex craniofacial wounds that have failed standard treatment and to understand how well these grafts work to repair wounds long term. Patients who have undergone free autologous dermal fat grafting to treat complex craniofacial wounds less than 1 week ago will have photographs and small biopsies taken of the area that was grafted. Patients will be followed for 2 years to monitor the area that was grafted.

NCT ID: NCT03602950 Not yet recruiting - Clinical trials for Diabetes, Gestational

PRP Use in Diabetic Patients Undergoing Cesarean Section

Start date: August 1, 2018
Phase: Phase 2/Phase 3
Study type: Interventional

this study will investigate the effectiveness of PRP in wound healing among diabetic patients undergoing elective cesarean sections

NCT ID: NCT02967627 Not yet recruiting - Clinical trials for Surgical Site Infection

VAC Dressings for Colorectal Resections

VACCRR
Start date: November 2016
Phase: N/A
Study type: Interventional

Surgical Site Infections (SSIs) and wound complications are common occurrences following colorectal resection surgery. Incisional Negative Pressure Wound Therapy (iNPWT) has developing evidence for improving wound complication rates in certain populations. However, there have been no RCTs to date that have looked at iNPWT use after colorectal surgery. We propose a study in which patients are randomized into one of two treatment arms: 1) incisional NPWT, and 2) standard sterile gauze dressings. Patients will be followed for 30 days for diagnosis of infection or wound complication. We will compare primary outcomes in each group using Chi-Squared statistical testing in order to report a Absolute Risk Reduction and Number Needed to Treat