Negative Pressure Wound Therapy Compared to Traditional Care After Skin Grafting
Wound of SkinWound Heal5 moreThe aim of this study is to compare negative pressure wound therapy to traditional care after split-thickness skin grafting in patients aged over 18.
Real World Evidence With the Debritom+ TM Novel Micro Water Jet Technology at a Single Wound Center...
Diabetic Foot UlcerVenous Leg Ulcer2 moreProspective, single-blinded, single-center, parallel group, randomized controlled trial (RCT) to assess rate and frequency of wound healing and associated financial savings, when using Medaxis debritom+ versus standard of care as a choice of debridement method, where both arms follow normal wound care practice in use of advanced wound care treatments.
Reinforced PTFE Meshes Versus Customized Titanium Meshes
Surgical ProcedureUnspecified5 moreThe objective of this study is to compare two surgical techniques for the treatment of the maxillary and mandibular bone atrophies.. Therefore, the main purpose is to compare the (i) the percentage of post-operative complications (ii) the three-dimensional bone gain with customized titanium meshes (test group - the medical device is digitally designed and made with customized laser sintering modality, customized to the defect of each patient) and with titanium-reinforced PTFE mesh (control group - the medical device is cut, shaped, and manually modelled to the patient's defect by the operator himself.
ciNPT in Autologous DIEP Flap Breast Reconstruction
Breast CancerWound Dehiscence1 moreIn women who undergo mastectomy for the treatment of breast cancer, autologous reconstruction using the deep inferior epigastric perforator (DIEP) flap is a common surgical procedure that aims to restore both the appearance and texture of the breast(s).Specifically, this requires the transfer of skin, fat, and perforator vessels from the abdomen to a recipient artery and vein in the chest to create a viable breast mound. Post-operatively, the abdominal donor site is routinely monitored for wound dehiscence, which has a reported incidence of up to 39% in this patient population; however, this incidence typically varies from 3.5% to 14%. At our academic institution, patients who undergo DIEP breast reconstruction typically have ciNPT or traditional tape dressings applied to the closed abdominal donor site. These dressings are selected according to surgeon preference and typically remain in-situ until hospital discharge. As there remains clinical equipoise regarding the ability of ciNPT to reduce abdominal wound dehiscence, further research in the form of a parallel, two-arm RCT is warranted. We propose a randomized controlled superiority trial with the primary objective of comparing the incidence of wound dehiscence at 1 month in patients undergoing autologous DIEP breast reconstruction with ciNPT versus standard tape dressings for the abdominal donor site incision. The design and conduct of the proposed study will mirror the methodology of the recently completed pilot trial (NCT04985552) including randomization, interventions, and clinical outcomes. The secondary objective of this study is to evaluate other clinical outcomes comparing ciNPT to standard tape dressings applied to the abdominal donor site incision. Secondary clinical outcomes will include: 2) the incidence of seroma formation and surgical site infection at 1 month; 2) quality of life as measured by BREAST-Q physical well-being abdomen and EQ-5D-5L pre-operatively, 1-month, 3-months, and 6-months postoperatively; 3) Scar appearance as measured by the SCAR-Q at 1-month, 3-months, and 6-months postoperatively. As an adjunct to the main study, another secondary clinical outcome will include the overall incidence of MINS as diagnosed by postoperative abnormally elevated troponin levels (as per site-specific laboratory assay thresholds) and electrocardiograms (ECG) at 6-12 hours and 1, 2, and 3 days after surgery.
A Real World, Observational Registry of Chronic Wounds and Ulcers
Diabetic FootVaricose Ulcer13 moreMore than 100 hospital based outpatient wound centers in the USA and Puerto Rico agree to transmit structured data on all patients followed with chronic wounds and ulcers (e.g. diabetic foot ulcers, venous ulcers, pressure ulcers, arterial ulcers, surgical wounds, and traumatic wounds). Data are collected at point of care including adherence to wound care quality measures developed by the USWR as a Qualified Clinical Data Registry (QCDR).
Optimizing Closed Incision Negative Pressure Wound Therapy in Emergency Laparotomy
Surgical Site InfectionSurgical Wound6 moreThe purpose of this study is to find differences in rates of surgical site infections following emergency laparotomy with the use of two different incisional negative pressure wound therapy (iNPWT)devices.
Repair of Challenging Abdominal Wall Defects: Strattice(TM) TM in Abdominal Wall Repair (StAR)
HerniaSurgical Wound DehiscenceThe objective of this study is to compare the incidence of post-repair wound related complications, including hernia occurrence/recurrence, between challenging abdominal wall defects repaired with Strattice(TM) Reconstructive Tissue Matrix (TM) and those managed by standard repair. It is hypothesized that the use of Strattice(TM) TM to reinforce the repair will reduce the incidence of these post-repair complications.
A Study, Performed in Subjects With Post Traumatic-post Surgical ,Venus Insufficiency and Diabetic...
Surgical Wound DehiscenceThis is a double-blind , randomized, controlled, two-arm study aiming to evaluate the safety and efficacy of Polyheal-2 vs PolyHeal, in once daily application as compared to historical control. The study will enroll adult subjects with post traumatic/post surgical, venus insufficiency and diabetic hard to heal wounds who meet the entrance criteria which will be followed for 12 weeks.
Evaluation of Safety and Efficacy of Using Seraffix LTB - System for Excisional Biopsy Wounds Closure...
DehiscenceSurgical WoundThe purpose of this study is to evaluate the safety and effectiveness of using Seraffix LTB system for excisional biopsy wounds closure
The Clinical Efficacy of RENASYS TOUCH NPWT System in the Management of Acute, Sub-acute and Chronic...
Wound and InjuriesSurgical Wound DehiscenceThe study is looking at the clinical efficacy, functionality and device performance of a new Negative Pressure Wound Therapy (NPWT) system in the management of a variety of wound types, in a real-life clinical setting. The study will comprise a prospective, open-labeled, multi-center study in a number of care-settings (both hospital and community) in South Africa. The patient's reference wound will be randomized to treatment with either intermittent or continuous NPWT mode to assess whether the delivery of NPWT via each of these therapy settings will have an effect on the rate and quality of wound healing.