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Surgical Wound clinical trials

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NCT ID: NCT05177874 Completed - Bleeding Clinical Trials

Traumacel FAM Trium in the Post-market Surveillance Phase

Start date: May 18, 2020
Phase: N/A
Study type: Interventional

The investigational medical device Traumacel FAM Trium is a sterile plant polysaccharide haemostatic agent based on the oxidized cellulose in the form of multilayer nonwoven fabric. It is used as an adjunct to stop capillary, venous, or small arterial bleeding, and also to prevent early postoperative bleeding. It can be used in all areas of stopping diffuse bleeding from resection surfaces such as parenchymatous organs, muscles or defined body cavities. The wide scope of application allows the use for classical, robotic surgery and endoscopic treatments (e.g. laparoscopic). The main objective of the study is to compare the efficacy and safety of Traumacel FAM Trium and regenerated oxidized cellulose based fibrous haemostat when used in accordance with their intended purpose. The partial objectives are: identification of any previously unknown side-effects and monitoring of known side-effects; identification and analysis of potentially newly emerging risks; confirmation of the acceptability of the benefit-risk ratio; identification of any systematic misuse of the device or off-label use of the device in order to verify the correctness of its intended purpose.

NCT ID: NCT05166681 Completed - Clinical trials for Surgical Wound Closure Technique

Evaluation of Aesthetic Surgical Wound Closure by a Single Layer in Comparison With Traditional Multi-layer Closure

Start date: September 1, 2020
Phase: Phase 3
Study type: Interventional

the study is comparing the results of aesthetic surgery wound closure by a single layer versus the traditional multi-layer closure as regards the wound healing time, local wound complications, and the scar formed.

NCT ID: NCT05148390 Completed - Diabetic Foot Ulcer Clinical Trials

Study to Examine Clinical Performance and Safety of Cutimed® Gelling Fiber in Routine Clinical Practice

GELFI
Start date: April 24, 2022
Phase:
Study type: Observational

This is a post - market study with a wound dressing, a CE-marked medical device available on the european market. The device will be used in routine clinical practice, i.e. within its intended purpose and without any additional invasive or stressing examinations for the patients. Up to 36 adult patients with wounds suitable to be treated with the medical device and meeting the inclusion/exclusion criteria will be enrolled at two participating German sites. During 5 on-site visits within 28 days routine weekly dressing changes the Health Care Professional will examine the wound and will perform required wound care and dressing changes. Pictures of the wound with and without dressing will be taken at each visit and used for automatic analysis. The subjects will be asked to rate their general wound pain and the pain perceived during dressing changes. A wound-related quality of life questionnaire will be presented to the subjects twice and the subject and HCP will rate their safisfaction with the product.

NCT ID: NCT05069103 Completed - Clinical trials for Surgical Site Infection

ImplementatioN of Remote Surgical wOund Assessment During the coviD-19 pandEmic

INROADE
Start date: July 5, 2021
Phase: N/A
Study type: Interventional

This is a implementation research study of a surgical wound tele-monitoring online tool developed at the University of Edinburgh and demonstrated in the "Tracking wound infection with smartphone technology" (TWIST) randomised control trial (NCT02704897) conducted in NHS Lothian. The study design is based on the Medical Research Council (MRC) "Guidance for developing and evaluating complex interventions".

NCT ID: NCT05018884 Completed - Clinical trials for Surgical Wound Infection

Surgical Site Infections at a West Cameroon Hospital

SSI Mbouo
Start date: April 26, 2021
Phase:
Study type: Observational [Patient Registry]

Surgical site infections (SSI) constitute an important health concern in low and middle income countries, leading to prolonged hospital stay and increased costs. Previous studies indicate that in Africa up to 1/3 of patients undergoing surgery may be affected by a postoperative infection. The development and implementation of context-specific SSI prevention guidelines is important to reduce this complication. To deploy efficient context-specific measures, data on epidemiology and microbiology of these infections are needed. This means to adapt the prevention measures to the context-specific risk factors for surgical site infections in resource-limited settings, and to give locally adapted recommendations on antimicrobial therapy based on local resistance patterns. However, data in this respect are scarce in low and middle income countries. This present study will contribute to the needed epidemiology and microbiology data on SSI in Cameroon. It will be carried out as a prospective cohort study at the Mbouo Protestant hospital in the West Region of Cameroon. The incidence, microbial spectrum and respective antimicrobial resistance of SSI as well as the risk factors of SSI will be systematically investigated. The study will include 300 patients at the Hôpital Protestant de Mbouo (HPM) who underwent surgery and gave their informed consent for inclusion, the timeframe is 04/2021 - 11/2021. An active SSI surveillance system will be put in place for 30 postoperative days to diagnose SSI. Expected outcomes: The incidence of SSI is likely to be higher than 10%. Concerning risk factors, preoperative bodywashing and perioperative antibioprophylaxis is expected to be protective against SSI. Up to 1/3 of SSI are expected to occur after hospital discharge. For the microbial spectrum, a high proportion of Staphylococcus aureus is likely to be found. For the antimicrobial resistance no estimation can be give as data is non-existent in that region from the literature.

NCT ID: NCT04996251 Completed - Pain, Postoperative Clinical Trials

Pre-incision Versus Post-incision Local Anesthetic During Robotic Sacrocolpopexy

CLAPPS
Start date: July 30, 2021
Phase: Phase 4
Study type: Interventional

Obtaining Likest-pain scale score on postoperative day one after injection of local anesthetic into incision sites of a laparoscopic/robotic-assisted sacrocolpopexy

NCT ID: NCT04888624 Completed - Surgical Incision Clinical Trials

A Comparison Between Two Post-operative Dressings

DrySee
Start date: September 13, 2021
Phase: N/A
Study type: Interventional

Surgical site infections are one of the leading causes of post-operative morbidity and mortality worldwide. The ideal post-operative dressing is impermeable and remains intact preventing contamination of the incision with microorganisms. In addition, it is often difficult for the patient to identify breaks in dressing integrity. This trial compares a post-operative dressing (DrySee® Inc. Houston Tx) with moisture detection allowing the patient to recognize when the dressing is compromised to a standard post-operative dressing (Tegaderm® + Pad, 3M, St. Paul, MN). The ideal dressing also allows the patient to shower without removing the dressing.

NCT ID: NCT04865952 Completed - Wound Heal Clinical Trials

Early Healing of Oral Soft Tissues: a Clinical and Biomolecular Analysis. Part III

Start date: April 29, 2021
Phase: N/A
Study type: Interventional

The purpose of the present study is to evaluate the effect of Hyaluronic acid application in the gene expression profile and cellular behavior in the early wound healing process -24 hours after injury- of the oral soft tissues.

NCT ID: NCT04818710 Completed - Clinical trials for Benifits of Using Diathermy in Skin Incision

Scalpel Versus Diathermy Skin Incision in Repeated CS

Start date: May 1, 2019
Phase: N/A
Study type: Interventional

This study was performed to compare both methods of skin incisions to determine differences in postoperative pain, hemodynamic changes, incisional time, blood loss during incision, wound healing, and wound complication.

NCT ID: NCT04735133 Completed - Colorectal Cancer Clinical Trials

The Effect of Wound Problems Wound Dressing in Patients With Colorectal Cancer Surgery

Start date: November 18, 2018
Phase: N/A
Study type: Interventional

This study was conducted as a randomized controlled trial in order to determine the effect of prophylactic negative pressure wound therapy for the prevention of surgical site complications in high-risk colorectal cancer surgery. Hypothesis: Prophylactic negative pressure wound therapy applied after open colorectal cancer surgery to high-risk patients affects surgical wound complications. pNBYT group: The study was completed with a total of 50 patients, 24 of intervention group anda 26 of the control group, who met the inclusion criteria at the surgical oncology service of a university hospital. The data were collected using Patient Identification Form, Surgical Procedure Form, Wound Follow-up Chart and ASEPSÄ°S Wound Scoring System. Ethics committee approval and written informed consent of the individuals was taken in the research. The data were analyzed in SPSS Statistics 24.0 program using Shapiro Wilk test and Q-Q graphs, Independent Sample t test, Mann Whitney U test, Chi-square, Cochran's Q and Friedman test. The value of p<0.05 was accepted for the statistical significance level. It was determined that the groups were similar in terms of identification and surgical procedure characteristics.