Clinical Research Directory

Prophylactic Antibiotic Duration in Head and Neck Cancer Surgery (PROTECT-HN Trial)

The goal of this clinical trial is to learn whether giving antibiotics for 7 days after surgery, instead of the usual 24 hours, lowers the chance of wound infection in adults having major surgery for mouth or throat cancer. This includes operations that rebuild the area with tissue taken from another part of the body (free-flap reconstruction). The main question it aims to answer is: Does a 7-day course of antibiotics after surgery lower the number of patients who get a surgical wound infection within 30 days, compared with the standard 24-hour course? Other questions are: Does the longer course shorten the time spent in the intensive care unit and in the hospital? Does it lower the number of emergency room visits, hospital readmissions, and hospital costs within 30 days? Is the longer course safe, and does it cause more side effects? Researchers will compare two groups. Both groups receive the same antibiotic (ampicillin/sulbactam) through a vein before and during surgery. After surgery, one group continues the antibiotic for 24 hours (the current standard), and the other group continues it for 7 days, or until they go home if that is sooner. Participants will: Be assigned by chance (like flipping a coin) to one of the two groups Follow the hospital's usual care before surgery, including mouthwash, antiseptic body wash, and nasal ointment for 5 days Receive the antibiotic according to their group Be followed for 30 days after surgery to check for wound infection, other complications, return visits, and readmissions

A Metagenomic Next-generation Sequencing (mNGS)-Guided Sequential Culture Strategy for Postoperative Cruciate Ligament Reconstruction Infection (CLRI): a Retrospective Cohort Study

This retrospective cohort study evaluates a sequential diagnostic strategy for patients with postoperative cruciate ligament reconstruction infection (CLRI). Diagnosing these infections is often difficult because conventional laboratory cultures can easily miss fastidious or slow-growing microorganisms. This study investigates whether using a rapid DNA-based test called metagenomic next-generation sequencing (mNGS) to guide and customize subsequent laboratory culture conditions can improve the detection rate of viable, live pathogens. The study includes 50 patients with CLRI and 30 patients with aseptic failure (non-infectious complications). The ultimate goal is to determine if this mNGS-guided modified culture strategy can help doctors identify the exact infection-causing germs more accurately, thereby allowing them to provide targeted, individualized antibiotic and surgical treatments.

Timing of Cesarean Wound Dressing Removal on Wound Healing in Women With BMI ≥ 30 kg/m²

Cesarean delivery is one of the most common surgical procedures in obstetric care. Women with obesity (body mass index \[BMI\] of 30 kg/m² or higher) are at increased risk for postoperative wound complications, including surgical site infections, fluid collections (seroma/hematoma), and wound separation. Postoperative wound dressings protect the surgical incision, but the optimal timing for dressing removal remains uncertain, particularly for high-risk patients. The purpose of this prospective cohort study is to compare wound healing and the occurrence of surgical site infections between two standard dressing removal schedules in women with a BMI ≥ 30 kg/m² undergoing cesarean delivery. Participants are observed in one of two groups according to standard hospital practice: * Group 1: The sterile wound dressing is removed at approximately 48 hours after surgery. * Group 2: The sterile wound dressing is removed at approximately 5 days after surgery. Following dressing removal, incisions are assessed for signs of infection, drainage, swelling, and healing progress. The study aims to provide evidence on whether earlier dressing removal at 48 hours is safe and effective compared to delayed removal at 5 days in women with obesity.

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.

Lower Extremity Graft Study (LEGS): A Multicentre Randomised Controlled Trial of Negative Pressure Wound Therapy Versus Conventional Dressings for Split-thickness Skin Grafts After Lower Leg Skin Tumour Excision

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 graft infection within 2 weeks 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.

Risk Factors for Mesh Infection After Abdominal Wall Reconstruction

Abdominal wall reconstruction (AWR) with mesh is the standard repair for ventral, incisional, parastomal and complex abdominal wall defects, but mesh-related infection remains one of its most serious complications - prolonging hospital stay, often requiring reoperation or removal of the mesh, and increasing the risk of hernia recurrence. Reported infection rates vary widely, and the independent contribution of individual risk factors remains uncertain, in large part because much of the existing evidence comes from retrospective series with inconsistent outcome definitions. This single-centre, prospective observational cohort study will enrol consecutive adults undergoing elective or urgent AWR with synthetic, biosynthetic or biological mesh at a tertiary referral hernia unit. Participants will be followed for 12 months on a fixed schedule (7-10 days, 30 days, 90 days, 6 months and 12 months). Using internationally accepted, prespecified definitions of mesh infection and surgical site occurrence, the study will collect up to 18 candidate patient, defect, operative and perioperative risk factors and analyse them by multivariable logistic regression to identify the independent predictors of mesh-related infection within 90 days of surgery. Secondary aims are to describe the incidence, timing, microbiology and management (salvage versus explantation) of mesh infection; to report surgical site occurrences and reoperation; and to derive an exploratory risk-stratification model. The findings are intended to support preoperative risk assessment, targeted patient optimisation, informed mesh and technique selection, and shared decision-making. The study is designed and reported in accordance with the STROBE statement.

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.

Primary Versus Delayed Wound Closure in Complicated Appendectomy (The HIEDI-Yemen Trial)

The goal of this clinical trial is to compare primary wound closure (PC) versus delayed primary closure (DPC) after standardized wound decontamination using the High-Efficiency Incision and Drainage with Irrigation (HIEDI) technique in patients undergoing open appendectomy for complicated appendicitis in Sana'a, Yemen. The main questions it aims to answer are: * Does primary closure with HIEDI result in a non-inferior or lower incidence of Surgical Site Infection (SSI) at 30 days compared with delayed primary closure with HIEDI? * Does primary closure with HIEDI reduce length of hospital stay and improve the trajectory of objective wound healing compared with delayed primary closure with HIEDI? * What is the impact of each closure method on patient satisfaction and health-related quality of life? Researchers will compare the two groups to determine the optimal, evidence-based standard of care for wound management in complicated appendicitis within a resource-limited setting. Participants will: * Undergo open appendectomy for intraoperatively confirmed complicated appendicitis (perforation or gangrene). * Receive standardized HIEDI wound decontamination (meticulous debridement and pulsatile irrigation with minimum 500 mL povidone-iodine 1:10 solution). * Be randomly allocated to either primary closure (all layers closed at surgery) or delayed primary closure (skin/subcutaneous tissue left open and closed 3-5 days later). * Attend follow-up visits at days 7, 14, and 30 for wound assessment, infection surveillance, and outcome evaluation.

Antibacterial-coated Sutures at Time of Cesarean

Abdominal closure with antibacterial-coated sutures has been shown to reduce wound infections after a number of surgical procedures, but none of the previous trials included cesarean delivery. Our objective is to determine whether use of antibacterial-coated sutures reduces surgical site infection (SSI) after cesarean delivery.

Non-Dressing vs. Routine Dressing Change After Gastrointestinal Cancer Surgery

The goal of this randomized non-inferiority trial is to evaluate whether omitting postoperative wound dressings is noninferior to routine dressing changes in patients undergoing gastrointestinal cancer surgery. The main questions it aims to answer are: 1. Is omitting dressings noninferior to routine dressing changes in preventing a composite of wound complications requiring clinical intervention? 2. Can omitting dressings reduce postoperative pain and eliminate dressing-related costs? Participants diagnosed with gastrointestinal tumors undergoing elective surgery will be randomly assigned to either the non-dressing group or the routine dressing group. The non-dressing group will have their initial dressing removed at 48 hours postoperatively, with no further coverage or disinfection unless clinically indicated. The dressing group will receive standardized dressing changes every 48 hours until suture removal at 7-14 days. Researchers will compare the two groups regarding the rate of wound complications, pain scores, and total dressing-related costs. This study aims to provide evidence-based recommendations for minimalist postoperative wound care, potentially improving patient comfort and reducing unnecessary medical expenses.

Preoperative Fasting and the Gut Microbiome Before Hip Replacement

Postoperative complications occur in 5-15% of patients undergoing elective primary total hip arthroplasty (THA), including periprosthetic joint infection (PJI), thrombosis, wound healing disorders, and metabolic dysregulation. The gut microbiome and the systemic immune profile have both been implicated as modifiable contributors to perioperative complication risk. Preoperative therapeutic fasting has been shown to remodel the gut microbiome, lower proinflammatory cytokines, and improve metabolic parameters. This single-center, prospective, randomized, two-arm controlled trial at Charité - Universitätsmedizin Berlin investigates whether a structured 20-day preoperative fasting intervention (alternating cycles of the Buchinger Fastenbox and intermittent fasting) modulates two co-primary endpoints - plasma IL-8 (a central proinflammatory marker) and gut microbial alpha-diversity (Shannon index) - compared with standard preoperative care. Secondary endpoints include further immune markers (TNFα, IL-10, T-/B-/NK-cell subsets, activation/exhaustion markers, monocyte HLA-DR), microbiome composition and function, continuous glucose-monitoring and daily metabolic measures, patient-reported outcomes (HOOS, PROMIS-33, infection self-report), and clinical outcomes (postoperative complications per EBJIS criteria, length of stay). Adults aged 18-75 undergoing elective primary THA are stratified by metabolic status (metabolically healthy vs. metabolically unhealthy according to harmonized metabolic-syndrome criteria) and randomized 1:1 to the fasting intervention versus standard care. Stool and whole-blood samples are collected at baseline (Day -21), and at Day +7 post-operatively for shotgun-metagenomic sequencing and multiparameter flow cytometry, with additional cytokine blood samples at Day -1 and 6 h / 24 h / 72 h post-operatively. Continuous glucose monitoring is performed in all participants from Day -21 until surgery. Planned enrollment is 130 participants.

The Application of Infrared Thermography in the Prediction of Skin Healing in Surgery

This study investigates whether infrared thermography, a harmless and non-invasive thermal camera technique, can help monitor how surgical wounds heal after skin surgery. The goal is to detect wound problems earlier, such as infection or delayed healing, and to support doctors in making timely clinical decisions.

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

Effectiveness of Postoperative Topical and Oral Antibiotics on Impacted Mandibular 3rd Molar Surgery.

This randomized controlled trial evaluates the effectiveness of postoperative topical antibiotics compared with oral antibiotics in patients undergoing surgical extraction of impacted mandibular third molars. The study aims to compare postoperative outcomes including infection, dry socket, pain, swelling, recovery time, patient satisfaction, and adverse effects associated with antibiotic use. A total of 90 participants undergoing mandibular third molar surgery will be randomly assigned to receive either topical antibiotic application at the surgical site or a standard postoperative course of oral antibiotics. Participants will be followed for 14 days after surgery with clinical assessments conducted at scheduled follow-up visits. Detailed Description: Impacted mandibular third molar extraction is one of the most commonly performed oral surgical procedures and is frequently associated with postoperative complications such as pain, swelling, infection, and alveolar osteitis (dry socket). Antibiotics are commonly prescribed after third molar surgery to reduce the risk of postoperative infections; however, routine systemic antibiotic use may contribute to adverse drug reactions and antibiotic resistance. Topical antibiotic application at the surgical site may offer localized antimicrobial effects while reducing systemic exposure and related complications. This study is a two-arm, parallel-group randomized controlled trial conducted at the Department of Oral and Maxillofacial Surgery, Liaquat College of Medicine and Dentistry, Karachi, Pakistan. The study duration is six months from February 2024 to July 2024. Ethical approval was obtained from the Institutional Review Board of Liaquat College of Medicine and Dentistry (REF.No.IRB/D-000090/24), and written informed consent is obtained from all participants before enrollment. A total of 90 participants aged 18 to 40 years undergoing surgical extraction of impacted mandibular third molars are enrolled and randomly allocated in a 1:1 ratio into two treatment groups using computerized block randomization with allocation concealment through sequentially numbered opaque sealed envelopes. Participants in the experimental group receive topical antibiotic application directly at the extraction site immediately after surgery, while participants in the comparator group receive a standard 5-day postoperative oral antibiotic regimen according to institutional protocol. All surgical procedures are performed under local anesthesia using standardized surgical techniques by qualified oral surgeons. Follow-up evaluations are conducted on postoperative days 1, 3, 7, and 14 to assess postoperative outcomes. The primary outcomes include postoperative infection and dry socket incidence. Secondary outcomes include postoperative pain measured using a Visual Analog Scale (VAS), facial swelling, patient satisfaction, recovery time, and adverse effects related to antibiotic therapy. Data are analyzed using Statistical Package for Social Sciences (SPSS) version 25. Descriptive statistics are used to summarize demographic and clinical variables. Comparative analyses between groups are performed using appropriate statistical tests, including chi-square tests for categorical variables, with a p-value of less than 0.05 considered statistically significant.

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.

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.