View clinical trials related to Surgical Wound Dehiscence.Filter by:
Prospective, 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.
This is a prospective, single arm study, consisting of 20 women with abdominal surgical wound dehiscence that requires secondary closure. The participants will receive a weekly application of ActiGraft for 4 weeks, or until complete healing of the wound (the earlier of the two). An historic matched-control group of 20 patients will be compared retrospectively
The ASOLO-SCI investigation is a Post Market Clinical Follow-up (PMCF) study to investigate the safety and performance of the Avance® Solo NPWT System in treating low to moderate exuding surgically closed incisions for up to 14 days when used in accordance with the Instructions for Use (IfU).
The presence of alveolar ridge deficiencies is considered major limitation to achieve an implant-prosthetic restoration with high aesthetics and stability over time. Guided Bone Regeneration (GBR) can be considered an effective solution for bone augmentation. The most advanced technology of GBR is the customized titanium mesh, which is developed with a fully digital work flow system. The aim of this study is to evaluate complications and bone augmentation rates after GBR, based on customized meshes with or without collagen membranes. After ethical committee approval, 30 patients with horizontal and/or vertical bone defects were enrolled and treated according to the study protocol. During reconstructive surgery (T0), patients were randomly divided into two study groups: 15 patients were treated by means of a custom-made mesh without collagen membrane (Group A - Control Group), while 15 patients were treated by means of a custom-made titanium mesh with a collagen membrane (Group B - Test Group). All sites were grafted with a mixture 50:50 of autogenous bone and xenograft and primary closures of surgical sites were obtained to ensure a submerged healing of the meshes. After 6 months (T1), re-entry surgery was completed to remove the meshes, evaluate the augmented volume and to place implants in the augmented sites. After 3 months (T2), soft tissue management was accomplished with implant exposure and a connective tissue graft, before prosthetic restoration (T3). Data collection included surgical and healing complications, planned bone volume (PBV) and reconstructed bone volume (RBV), pseudo-periosteum type, bone density, implant success, and crestal bone loss. A statistical analysis of recorded data was performed to investigate any statistically significant differences between the study group and statistical significance was set at a=0.05.
The 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.
Multi-center study on the effectiveness of treatment with a blue light medical device (EmoLED) in the reduction of ulcer surface in 10 weeks. The aim of BLUR clinical trial is to verify if the proposed treatment represents a valid and significant remedy for Chronic Venous Insufficiency ulcers. The effectiveness will be measured through the evaluation of the reduction percentage of the lesion area during 10 weeks of treatment comparing the lesion (or portion of it) treated with EmoLED versus the control lesion (or portion of it) treated only according to current Standards of Care(SOC). In the 10 weeks following the recruitment, the patient continues to follow the usual topical therapy with a frequency of once a week visit. The patient will be monitored up to the first event occurring: Complete healing or ten weeks. During the study, reports and evaluations will be made by medical staff on the device safety and usability. 90 patients will be recruited corresponding to the following criteria: - Subjects suffering from venous, arterial and mixed skin ulcers and surgical dehiscence lesions; - Presence of similar multiple lesions or lesions larger than 5 cm ; - Men and women ≥ 18 years old; - The patient must be able to understand the aims of the clinical study and provide informed consent in writing; - Chronicity of the lesion: at least 8 weeks. The present clinical trial will be a multi-center prospective, controlled study with the aim of verifying the clinical efficacy of a portable battery-powered device based on blue LEDs. We expect to record at least 20% of the difference between treated lesion and untreated lesion on the same patient during observation time. The treatment, additional to the standard therapy for the patient, will be performed at each visit for 60 seconds on each 5 cm diameter sub-area of the selected lesion or on part of it. In case of multiple lesions, one will be treated with EmoLED and one will be selected as a control lesion. In case of a very extensive lesion, it will be divided into two and one half will be the control of the other. All lesions will be cleansed with saline solution and a surgical debridement will be performed with a scalpel if a slough/black base is present. Only then the treatment with EmoLED will begin. If the patient has more than one lesion at the recruitment time, and all lesions are less than 5 cm in diameter, the worst lesions will be treated entirely with the EmoLED device and the others will constitute the control lesions. The evolution of all lesions in the ten weeks of the study duration will be evaluated. If the patient has only one lesion greater than 5 cm in diameter at the recruitment time, the lesion will be divided into two parts along the major side and one half of the lesion area will be treated. The other half of the lesion will be masked with multi-layered sterile gauze during treatment. The point of division of the lesion into two parts will be indicated with an indelible marker and retouched at each visit. If, at the time of recruitment, the patient has more than one lesion with a diameter greater than 5 cm, all lesions will be divided into two along the major side and will be treated as in the previous case. After treatment with EmoLED, a hydrofiber dressing will be applied to the lesion. If clinical signs of infection occur, a hydrofiber dressing with silver will be applied. If necessary, compressive bandage of the limb will be carried out.
This will be an open label pilot randomized controlled clinical trial. Women undergoing cesarean delivery will be randomized to have standard wound dressing care or chlorohexidine gluconate (CHG) impregnated wound dressing (ReliaTect™ Post-Op Dressing).
Can improvements in patient dismissal education materials reduce incidence of wound non-healing and infection.
This research is about the use of subgaleal drains to prevent accumulation of blood under the skin in patients undergoing surgery to remove part of the skull(craniectomy) and its associated complications. There have been early research that shows usage of subgaleal drains maybe related to increase in complication rates after craniectomy. These complications include hydrocephalus (accumulation of fluid in the brain), new hemorrhages, infection and low blood pressure. The investigators are performing this research to determine which type of subgaleal drains would produce the least complications. With this knowledge, the investigators would be able to reduce the amount of complications for future patients that undergo surgery to remove part of the skull. The purpose of this study is to determine the rate of complications in the 3 different groups of patients using the different types of drains under the skin in surgeries that involve removal of part of the skull. All participants will undergo the required surgery to remove part of the skull (craniectomy). Participants will then be randomly assigned to either one of 3 groups which are the vacuum drain group, passive drain group or no drain group.Participants in the vacuum drain group will have vacuum drains inserted during the closing stage of the surgery. Participants in the passive drain group will have passive drains inserted during the closing stage of the surgery. Participants in the no drain group will have a drain inserted during the closing stage of the procedure but the drain will remained closed. Data will then be collected and analysed to determine if the type of drains influence the rate of complications in craniectomy
Negative pressure wound closure technique (NPWT) has been widely introduced in different clinical settings. Most of the studies report it as an effective and cost-effective method to treat complicated surgical wounds or even open abdomen. NPWT as a prophylactic effort to prevent complications of high risk surgical wounds has recently been introduced, but the concept is still lacking clinical evidence in terms of clinical effectiveness and cost effectiveness. In this randomized, multi centric study investigators aim to compare prophylactic negative pressure wound closure (ciNPWT) with traditional, dry wound dressing at high infection risk laparotomy wounds.