Clinical Research Directory

A Study of Amicidin-β Topical Solution for Patients With Surgical or Traumatic Wound Infections

The goal of this Phase 1 clinical trial is to learn about the safety profile of Amicidin-β topical solution applied directly into infected surgical or traumatic wounds during a surgical procedure. The main questions it aims to answer are: 1. Is Amicidin-β topical solution safe to test in larger clinical trials? 2. Is Amicidin-β topical solution absorbed into the bloodstream from local wound application? 3. Is Amicidin-β topical solution easy for the surgeon to use? Participants will receive either standard of care alone, or standard of care with intrawound Amicidin-β topical solution for the management of their wound infection. Researchers will compare these two groups (standard of care alone to standard of care with Amicidin-β topical solution) to see if there are any study drug-related adverse effects.

Light-Activated Antimicrobial Therapy to Prevent Surgical Site Infections

This is a Phase 3 multi-center, group-randomized, crossover trial to compare nasal antimicrobial photodisinfection therapy (aPDT) with standard of care for prevention of surgical site infections in patients undergoing major elective, urgent, or emergent surgeries in a hospital setting. The main outcomes are to: 1. compare the efficacy, and 2. estimate the safety of applying nasal (aPDT) before surgery in reducing the incidence of SSIs within the initial 30 days after surgery compared to standard of care (SOC). Participants in the intervention group will receive aPDT prior to surgery on the day of surgery. Participants in the control group will receive standard of care surgical site prevention measures prior to surgery.

NPWT in Patients Undergoing Surgical Procedures for Management of GI Malignancies

This randomized trial will use a Negative Pressure Wound Therapy device or standard wound closure, in participants with gastrointestinal neoplasms, to measure the rate of surgical site infections

Safety and Efficacy of NTP in Thyroid Surgery: Pilot Study on Morbidity Prevention and Adjuvant Oncological Control

The goal of this clinical trial is to evaluate the therapeutic efficacy and safety of non-thermal plasma (NTP) as an adjuvant treatment for surgical bed decontamination and accelerated tissue repair in patients undergoing total thyroidectomy. The study aims to address the following objectives: * Does the intraoperative application of NTP to the surgical bed and closed incision promote accelerated tissue regeneration compared to conventional postoperative care? * Does NTP treatment reduce postoperative inflammatory response, pain intensity, and the incidence of site-specific complications (such as surgical site infection or seroma)? * What is the safety profile of helium-based NTP in the cervical anatomical region regarding neighboring neurovascular structures? Participants will be randomized into two arms: 1. The experimental group: Receiving a standardized application of helium-based NTP (at a frequency of 13.56 MHz) to the surgical bed prior to closure and subsequently to the sutured incision. 2. The control group: Receiving standard-of-care surgical wound management. Clinical follow-up will include quantitative assessment of healing rates, pain scales (VAS), and biochemical or clinical markers of inflammation at scheduled intervals (Days 1, 7, 15, and up to 12 weeks post-surgery).

Comparing Outcomes Of Single Layer Versus Multilayer Leg Closure Techniques Following Great Saphenous Vein Harvesting For CABG

This study aims to address the knowledge gap by comparing the outcomes of single-layer and multi-layer leg closure techniques following great saphenous vein harvesting for Coronary artery bypass grafting. Research question: 1. Does single-layer closure compared to multi-layer closure result in better postoperative outcomes in patients undergoing great saphenous vein harvesting for CABG 2. To evaluate the incidence of postoperative complications (e.g., infection, hematoma, wound dehiscence, seroma) associated with single-layer vs. multi-layer closure techniques. participants will follow in OPD after 1 week , their wounds will be examined and assessment will be recorded.

Small Bites Vs Large Bites Abdominal Midline Incisional Closure

The goal of this trial is to compare the effectiveness of small bite versus large bite abdominal incision closure in emergency settings. It will also evaluate the safety and outcomes of each technique. The main questions it aims to answer are: Does small bite closure reduce the incidence of superficial surgical site infections (SSI), wound dehiscence, and incisional hernia compared to large bite closure? What are the associated complications of each closure technique? Participants will: Undergo either a small bite or large bite abdominal incision closure during emergency laparotomy Visit the clinic for follow-up assessments at 7 days, 15 days, 1 month, 3 months, and 6 months post-operatively Have their wound healing and complications documented and analyzed during respective visits.

The Effect of Bacterial Decolonization Before Skin Cancer Surgery on Infection Rate of Lower Extremity Wounds Left Open to Heal

The goal of this clinical trial is to learn if reducing bacterial load on the skin and nostrils with topical antibacterial soap and ointment, respectively, reduces rate of infection in surgical sites on lower leg wounds left open to heal in adults undergoing skin cancer surgery. The main question it aims to answer is: Does Hibiclens antibacterial skin cleanser and mupirocin antibacterial ointment applied to nostrils prior to surgery lower the number of times participants develop an infection in their open wound on the lower leg? Researchers will compare the treatment group to the standard of care, which involves no treatment prior to surgery, to see if topical antibiotics applied prior to surgery affect infection rates between the two groups. Participants randomized to the treatment group will: Shower with Hibiclens once daily for 5 days prior to the day of surgery and apply mupirocin to the nostrils twice daily for 5 days prior to the day of surgery. They will then send pictures of their surgical site to monitor for signs of infection at 2-week and 4-week post-operation. Participants randomized to the control group (standard of care) will: NOT apply the topical antibacterials prior to the day of surgery. They will then send pictures of their surgical site to monitor for signs of infection at 2-week intervals for 1 month after surgery.

Negative Pressure Wound Therapy for Split Thickness Skin Grafting to the Lower Leg After Excision of Skin Tumour: A Multicentre Randomised Study

The goal of this clinical trial is to compare the effect of negative pressure wound therapy (NPWT) versus traditional dressings on the incidence of transplant infection in adult patients undergoing split-thickness skin grafting (STSG) to the lower leg following excision of a skin tumour. The main questions it aims to answer are: Does NPWT reduce the incidence of transplant infection within three months after STSG? Does NPWT improve secondary outcomes such as graft take, reduce reoperations, complications, and resource use? Researchers will compare patients treated with NPWT to patients treated with traditional dressings to see if NPWT results in lower infection rates and better clinical outcomes. Participants will: Undergo excision of a skin tumour on the lower leg followed by STSG. Be randomized to receive either NPWT or traditional dressings applied over the graft. Follow a structured postoperative care and mobilisation schedule. Attend follow-up visits at day 5 and day 14 postoperatively and be monitored through medical record review up to three months after surgery.

Perioperative Respiratory Care and Outcomes for Patients Undergoing High Risk Abdominal Surgery

PENGUIN is a pragmatic multi-center trial investigating the effects of pre-operative mouthwash and perioperative oxygen on the incidences of pneumonia and surgical site infection (SSI) following major abdominal surgery. Patients will be recruited from low and middle income countries and randomly assigned to a trial treatment arms: a) pre-operative chlorhexidine mouthwash and 80-100% FiO2; b) no pre-operative mouthwash and 80-100% fraction of inspired oxygen (FiO2); c) pre-operative chlorhexidine mouthwash and 21- 30% FiO2; or d) no pre-operative mouthwash and 21-30% FiO2.

Multicenter Study Protocol: Research on Evaluation and Detection of Surgical Wound Complications with AI-based Recognition. (REDSCAR-trial)

The increasing use of telemedicine in surgical care has demonstrated significant poten-tial for improving patient outcomes and optimizing healthcare resources. This study investigates the efficacy of the RedScar© app in telematic detection and monitoring of surgical site infections (SSIs), a major cause of healthcare-associated infections (HAIs) with significant economic and health impacts. RedScar© leverages a patient's smartphone to provide automated infection risk assessments without requiring clini-cian input, offering a potential solution for remote postoperative care. In a pilot study, RedScar© demonstrated 100% sensitivity and 83.13% specificity in detecting SSIs, with high patient satisfaction regarding its comfort, cost-effectiveness, and ability to reduce absenteeism. This multicenter prospective study aims to validate these findings, com-paring app-based detection with in-person evaluations. Primary objectives include as-sessing the sensitivity and specificity of RedScar© using receiver operating character-istic (ROC) analysis, while secondary objectives include evaluating patient satisfaction and standardizing telematic follow-up across centers. The study will include 168 pa-tients undergoing abdominal surgery, with follow-up assessments conducted remotely via the app and in-person at specified intervals. Data will be analysed using descrip-tive and statistical methods to assess diagnostic accuracy and patient satisfaction. This research seeks to further develop RedScar© as a reliable, scalable tool for enhancing postoperative care, reducing healthcare costs, and improving patient experiences in surgical recovery.

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

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.

Closed Incision Negative Pressure Wound Therapy for the Prevention of Surgical Site Infections in Abdominal Surgery

Surgical site infections (SSI) are a frequent complication in abdominal surgery. SSI lead to worse outcomes for the affected patients and significantly higher healthcare costs. Closed incision negative pressure wound therapy (ciNPWT) consists of a non-invasive, vacuum-assisted system that applies negative pressure to closed surgical incisions. It is currently unclear, if ciNPWT reduces SSI in patients undergoing abdominal surgery. This trial will investigate the effect of ciNPWT on SSI in abdominal surgery.

Surgical Handwashing: Drying With One or Two Surgical Towels

This study aims to determine whether the use of two sterile towels for drying after surgical handwashing results in fewer contamination events compared to the use of only one towel among healthcare personnel. This randomized, multicenter, superiority-controlled trial will enroll up to 72 healthcare workers and surgical residents from three hospitals in Bogotá, Colombia. A fluorescent product will simulate bacteria, and contamination will be assessed by evaluating the presence of fluorescent cream after hand drying technique with either two or one surgical sterile towel. Data will be collected through REDCap and deidentified. Differences in the proportion of contamination between the two groups will be assessed using an exact Fischer test, and confounding variables will be included in the analysis through logistic multivariate regression, with a significance level set a priori at 0.05. Results will be submitted for publication in a peer-reviewed journal.

Sucrose as a Standard in Cesarean Section Surgical Wound Healing to Reduce Hospital Time

It is a randomized, single-blind clinical trial, whose population to be studied will be randomized patients with a diagnosis of dehiscence and infection of a cesarean surgical wound who meet the inclusion and exclusion criteria. H0: Sucrose does not reduce hospital days in patients with surgical wound dehiscence. HA: Sucrose reduces hospital days in patients with surgical wound dehiscence.

Reducing Intraoperative ESKAPE Transmission Through Use of a Personal Hand Hygiene System

The investigators hypothesize that the use of a personal hand hygiene system (SafeHavenTM) by anesthesia providers in the adult operating room, combined with a novel infectious pathogen tracking system (OR PathTrac) will decrease participant exposure to pathologic bacteria in the adult operating room.