Clinical Research Directory

Effect of Curcumin Topical Spray on Wound Healing After Tooth Extraction

This randomized, single-blind, controlled clinical trial aims to evaluate the effects of a topical curcumin spray on post-extraction wound healing and postoperative symptoms in adults undergoing first molar extraction. Participants will be randomly assigned to one of three groups: curcumin topical spray, 0.12% chlorhexidine topical spray, or standard postoperative care without a topical spray. The interventions will be applied twice daily for 7 days. Postoperative pain will be assessed using a visual analog scale, while wound healing will be evaluated using the Landry, Turnbull, and Howley Healing Index. Wound dimensions will also be recorded during follow-up. In addition, salivary levels of inflammatory biomarkers, including interleukin-1β (IL-1β), tumor necrosis factor-alpha (TNF-α), and prostaglandin E2 (PGE2), will be analyzed to assess the local inflammatory response during the postoperative healing period.The study aims to compare the clinical effects of topical curcumin with chlorhexidine and standard postoperative care during the early healing period after tooth extraction.

MEBO Bio-Dressing on Patient-Reported Outcomes and Tissue Healing Following Rotary Gingival Depigmentation

The purpose of this randomized, single-blind, parallel-group clinical trial is to evaluate the clinical efficacy of Moist Exposed Burn Ointment (MEBO) as a biological topical dressing compared to open secondary healing (no dressing) following rotary gingival depigmentation in adult patients. The study aims to investigate whether the application of MEBO reduces postoperative pain intensity, decreases rescue analgesic reliance, accelerates soft-tissue wound healing, and improves oral health-related quality of life over a 1-month follow-up period.

Management of Abdominal Post-surgical Scar With Ozoaqua Versus Standard Care

A prospective, randomized clinical study with a blinded evaluator to compare a post-surgical abdominal scar care protocol using Ozoaqua products versus standard care in patients undergoing open abdominal surgery. The primary objective is to assess whether the use of Ozoaqua, initiated in the immediate postoperative period according to wound evolution, improves abdominal scar quality at 3 months compared with usual care. The proposed design is an initial single-center study at the Clínica Universidad de Navarra, with 1:1 random allocation to two parallel arms: an intervention group receiving standard care plus Ozoaqua ozonated soap and oil, and a control group receiving standard care only. The primary scar assessment will be performed by a blinded evaluator, while treatment will be open-label due to the nature of the topical intervention. The target population consists of adult patients undergoing scheduled open abdominal surgery, with primary wound closure and an assessable linear abdominal scar. Follow-up will be integrated into routine clinical care, including an in-hospital phase during the first postoperative days and outpatient visits at approximately 2 weeks, 1 month and 3 months, with the latter being the main study visit. The primary endpoint will be scar quality at 3 months, assessed using the POSAS scale, particularly the blinded observer score. Secondary endpoints will include the patient POSAS score, scar evolution, wound complications, pain, pruritus, satisfaction, cutaneous adverse events, rescue treatments and adherence.

Topical 0.5% Timolol Solution for Healing Lower Extremity Wounds

Topical timolol, a β2-Adrenergic receptor (B2AR) antagonist, has demonstrated promise in wound healing over the past several years. The majority of the literature has evaluated the use of topical timolol to shorten wound healing time in chronic wounds of non-surgical etiologies. To date, there are no prospective randomized clinical trials evaluating the role of topical timolol for shortening wound healing time in acute open surgical wounds. Therefore, the purpose of this study is to determine whether or not topical timolol solution decreases time to wound healing in patients with defects after Mohs Micrographic Surgery (MMS) that cannot be closed with sutures and are left to heal by second intent. The research team also will look to determine if there is a difference in cosmesis of wounds treated with topical timolol compared to those treated with the standard of care. The present study will primarily focus on wounds in the distal lower extremity as these are most commonly left to heal by secondary intent

Effect of GaAlAs 940 Laser on Pain and Wound Healing After Free Gingival Graft

This randomized controlled clinical trial aims to evaluate the biomodulatory effects of a 940-nm GaAlAs diode laser on postoperative pain control and wound healing at the palatal donor site following free gingival graft harvesting. Adult patients undergoing free gingival graft surgery will be randomly allocated to receive either a single session of adjunctive diode laser irradiation immediately after surgery or sham laser irradiation without therapeutic laser energy delivery. Postoperative pain will be assessed using a visual analog scale, while clinical parameters related to wound healing, including bleeding tendency, epithelialization, and wound size reduction, will be evaluated at predefined follow-up time points. The findings of this study may contribute to the clinical understanding of photobiomodulation in free gingival graft surgery.

Cyanoacrylate Skin Adhesive After Mohs Surgery or Wide Local Excision

This study will compare surgical site infection after linear repair with or without cyanoacrylate skin adhesive following Mohs micrographic surgery or wide local excision. Adult participants undergoing Mohs micrographic surgery or wide local excision for skin cancer with a surgical defect suitable for linear repair will be stratified by suture type and randomized to standardized running epidermal suture closure with or without cyanoacrylate skin adhesive. The primary outcome is surgical site infection within 30 days after surgery. Secondary outcomes include scar quality, treatment satisfaction, wound care burden, wound healing characteristics, antibiotic use, culture results, health care utilization related to wound concerns, and adverse events.

Effects of Standard PRP and Extracellular Vesicle-Enriched PRP on Human Gingival Fibroblasts

The goal of this study is to compare the biological effects of two blood-derived products, standard platelet-rich plasma (PRP) and extracellular vesicle-enriched PRP (EV-enriched PRP), on human gingival (gum) fibroblasts, the cells responsible for gum tissue repair. PRP is a concentrate of platelets prepared from a person's own blood and is used in periodontal and soft tissue regeneration because it releases growth factors. Extracellular vesicles (EVs) are nanometer-sized particles released by platelets that carry proteins and genetic material and may play an important role in tissue healing. No study has yet directly compared standard PRP with an EV-enriched formulation on gingival fibroblasts. The main questions this study aims to answer are: * Does EV-enriched PRP increase gingival fibroblast proliferation more than standard PRP? * Does EV-enriched PRP accelerate gingival fibroblast migration (wound closure) more than standard PRP? * Do the two products differ in their effects on the expression of growth factor and collagen genes in gingival fibroblasts? Six healthy, non-smoking adult volunteers aged 20 to 40 years will each give a single blood sample (two tubes, 18 mL in total) from an arm vein. No treatment will be given to the volunteers. Each volunteer's blood will be processed into both standard PRP and EV-enriched PRP, and both products will be tested in the laboratory on a commercially available human gingival fibroblast cell line.

Sutureless Versus Conventional Suturing in Oral Surgery

This randomized clinical study compares sutureless wound closure using n-butyl-2-cyanoacrylate tissue adhesive with conventional silk suturing following minor oral surgical procedures. The study evaluates wound healing as the primary outcome, along with postoperative pain, time to hemostasis, closure time, intraoperative blood loss, and postoperative complications. Eighty patients were randomly allocated in a 1:1 ratio to either sutureless closure or conventional suturing and were followed for 14 days after surgery.

Efficacy of Early Postoperative ON101 Application for Lower-extremity Fracture Incisions: a Prospective Evaluator-blinded Controlled Study of Scar Quality and Digital-clinical Concordance

Background: Postoperative scars after lower-extremity fracture fixation endure high tension, where excessive scarring can restrict periarticular mobility. While the 2002 International Clinical Recommendations on Scar Management emphasize early prevention, conventional silicone products require complete epithelialization before use. Conversely, ON101 is a topical formulation. The formulation helps to maintain the wound moist environment, and the moist wound environment is conducive for wound healing. This profile suggests potential for earlier intervention. We evaluated whether initiating ON101 during the early postoperative repair phase improves subsequent wound healing and scar maturation. Methods: This prospective, evaluator-blinded, controlled study enrolled 30 adults undergoing open reduction and internal fixation for lower-extremity fractures. Patients received once-daily topical ON101 (n=20) or standard care (n=10), initiated within 3 days postoperatively before complete epithelialization, and continued for 16 weeks. Blinded clinicians assessed scar maturation using the Vancouver Scar Scale (VSS). Standardized photographs were quantitatively analyzed using CIELab color parameters and gray-level co-occurrence matrix (GLCM) texture features.

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.

ENVELOP: Wound Care Following Pilonidal Sinus Surgery

This is a single-blinded, multicentre, prospective randomised controlled trial (RCT) comparing post-operative and patient-reported outcomes for patients undergoing application of negative-pressure wound therapy (NPWT) after sinus tract excision as compared to excision and standard open wound care in chronic pilonidal sinus disease (PSD).

Comparison of Wound Healing Duration Between Vacuum-Assisted Closure (VAC) and Conventional Dressings

This randomized controlled trial will compare vacuum-assisted closure (VAC) therapy with conventional wound dressings for the treatment of open contaminated and dirty wounds. The study will be conducted in the Department of General Surgery, Jinnah Postgraduate Medical Centre (JPMC), Karachi. Eligible patients aged 15 to 60 years with open contaminated or dirty wounds measuring 5-10 cm and classified as American Society of Anesthesiologists (ASA) grade I or II will be randomly allocated to either VAC therapy or conventional dressings. The primary outcome will be mean duration of wound healing, measured in days from initiation of the assigned treatment until complete wound healing according to predefined clinical criteria. The study will compare the duration of wound healing between the two treatment groups.

Nutritional Status in Adults With Diabetic Foot Ulcers

This feasibility and pilot study has two aims. The primary aim is to assess the feasibility of collecting clinical, nutritional, and functional data among adults with diabetic foot ulcers (DFUs) who are treated at an outpatient wound clinic. Specifically, the study will evaluate recruitment and inclusion rates, the relevance and clinical utility of selected variables, and assess the completeness and reliability of data collection. The secondary aim is to provide a preliminary characterisation of nutritional status, dietary intake, body composition, muscle strength, mobility, and wound-related quality of life, to inform the design and methodology of a future full-scale national study. DFUs are associated with delayed healing, recurrent infections, reduced quality of life, and increased risk of hospitalization and amputation. These conditions are frequently accompanied by systemic inflammation, impaired circulation, and metabolic disturbances, which may increase nutritional requirements and negatively affect wound healing. Despite nutrition being recognized as a modifiable factor of ulcer healing, the nutritional status of individuals with DFUs remains insufficiently characterised, and evidence regarding clinically relevant nutritional deficiencies in this population is limited. Participants will undergo assessment of height, weight, body composition, handgrip strength, and a 24-hour dietary recall interview during an outpatient clinic visit. Nutritional screening questionnaires and patient-reported measures of appetite, nutritional impact symptoms, mobility, and quality of life will be collected through telephone interviews within one week of the clinical visit. Eligible participants are adults (\>18 years) who are referred to the outpatient wound clinic with a hard-to-heal foot ulcer. Participants must be able to communicate in Danish or English.

Effectiveness of Chlorhexidine Impregnated Gauze Versus Povidone Iodine Dressing in Post Trauma Wound Care

To compare rate of infection and wound healing between chlorhexidine impregnated paraffin gauze and dry povidone-iodine dressings in post-traumatic wounds.

Evaluation of the Safety and Performance of a Bioresorbable Nasal Dressing Containing Mometasone Furoate

The objective of this study is to investigate the safety and performance of OCEAN® as an adjunct in wound healing after nasal/sinus surgery by using OCEAN® in patients undergoing nasal/sinus surgery.

Hydrocolloid Dressings for Oculofacial Plastic and Reconstructive Wound Healing

This study aims to explore the use of a hydrocolloid dressing (DuoDERM EXTRA THIN) as an alternative to the current standard of care. The dressing would be applied immediately after surgery and removed at a post-operative week 1 appointment. The dressing would eliminate the need for antibiotic ointment application and reduce the burden of post-operative care on the patient.

Topical Rifamycin SV for Wound Healing After Sapphire FUE Hair Transplantation

This prospective, parallel-group controlled clinical study evaluated whether a single topical rifamycin SV protocol added to standardized care after sapphire follicular unit extraction (FUE) was associated with earlier recorded wound healing. One hundred candidates were assessed, and 70 men were individually allocated 1:1 using MedCalc. Five participants were excluded after allocation but before surgery and before receiving the assigned intervention because final preoperative serological testing met prespecified exclusion criteria. The analyzed sample comprised 34 participants in the rifamycin SV group and 31 in the control group. Healing was assessed through postoperative Day 14 using scheduled clinical review and serial photographs. Infection and hypersensitivity were monitored as safety outcomes.

Post-Extraction Wound Healing in Elderly

Patients presenting to the University of Nebraska Medical Center College of Dentistry for a posterior extraction will be offered participation in the study. Prior to extraction, subjects will undergo clinical measurements, xray, gingival crevicular fluid (GCF) and saliva sampling and a blood draw. Following atraumatic tooth extraction, the subjects will be reevaluated for healing at 1, 2-weeks and 3 months. At each appointment, GCF, saliva and wound fluid (WF) will be collected and at 3 months a second xray will be taken.

Effects of CGF and Collagen Fleece on Palatal Donor Site Healing: A Randomized Clinical Trial

This study investigated whether applying Concentrated Growth Factor (CGF) or Collagen Fleece (CF) to the palatal donor site after autogenous soft tissue graft harvesting could improve wound healing and reduce postoperative discomfort. The palatal donor site often requires several weeks to heal, and patients may experience pain, delayed epithelialization, and difficulty in daily oral functions. Biologically active materials such as CGF and collagen-based dressings may help accelerate tissue repair and improve patient comfort. A total of 38 systemically healthy adults requiring soft tissue graft harvesting were enrolled and assigned to three groups: CGF, CF, or control. In all groups, the applied material was stabilized with sutures and covered with an oral wound dressing. Palatal tissue thickness was measured at baseline and at 1, 3, and 6 months. Wound healing was evaluated on postoperative days 3, 7, and 14 and at 1 month using standardized clinical indices. Patient-reported outcomes, including pain, analgesic use, and oral health-related quality of life, were also recorded. The study aims to determine whether CGF or CF provides superior healing, better preservation of palatal tissue thickness, and reduced postoperative morbidity compared with spontaneous healing. Findings from this trial may help clinicians select supportive materials that enhance donor-site healing and improve patient comfort after periodontal soft tissue graft procedures.

Systemic Biochemical Signature and Functional Quality Index of Calcaneal Bone Marrow Aspirate in Adults Undergoing Foot or Ankle Surgery

This observational prospective cohort study will evaluate whether routine blood tests are associated with the functional quality of calcaneal bone marrow aspirate mesenchymal stem cells in adults undergoing clinically indicated foot or ankle surgery at a university hospital in Brazil. Participants aged 40 to 80 years, with or without comorbidities, including type 2 diabetes mellitus and, when present, active Wagner grade 2-4 diabetic foot ulcers, will be eligible for inclusion. Before surgery, participants will undergo routine blood tests, including complete blood count, glucose and lipid profile, mineral-renal markers, and tissue damage markers. During the clinically indicated surgery, calcaneal bone marrow aspirate will be collected from the same operative field. Mesenchymal stem cells will be isolated and evaluated in the laboratory for clonogenic capacity, osteogenic and adipogenic differentiation, cellular senescence, and secretion of inflammatory and anti-inflammatory cytokines. A composite Functional Quality Index of Bone Marrow Aspirate (IQF-BMA) will be constructed from routine laboratory markers to characterize inflammatory, metabolic, mineral-renal, and tissue-damage burden. The primary objective is to examine the association between the IQF-BMA and mesenchymal stem cell functional outcomes, particularly clonogenic capacity. This exploratory study will not be used to guide individual treatment decisions.

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.

Fucoidan(Seaweed) Based Gel Around Osseous Defects

The current study is a prospective case series study to evaluate the effect of Fucoidan gel around osseous defects to assess the wound healing and bone regeneration

Evaluating rhPDGF-BB-Enhanced Wound Matrix for Head and Neck Reconstruction

Skin cancers such as basal cell carcinoma (BCC), squamous cell carcinoma (SCC), and melanoma lesions that develop on the head and neck are treated by Mohs surgery or wide local excision to remove all tumor cells and preserve the normal tissue. These surgical techniques may result in large defects requiring reconstruction to restore function and aesthetics. Rotational flaps and free flaps are techniques used to reconstruct large, complex defects that cannot be closed with sutures, staples, or glue. Older, frail patients are particularly vulnerable to complications from these procedures often leaving them to care for chronic wounds until a skin graft can be placed. Phenome-wide association studies (PheWAS) revealed a cohort of patients with a single nucleotide variant (SNV) in PDGFRβ having a higher incidence of chronic skin ulcers, skin grafts, and other skin and connective tissue disorders suggesting that the loss of PDGFβ signaling may impair healing following trauma. rhPDGF-BB, a recombinant human platelet derived growth factor protein-based therapy, signals through PDGFRβ to mediate inflammation, granulation, angiogenesis, and remodeling during wound healing and skin repair and is FDA cleared for diabetic neuropathic ulcers and periodontal bone and soft tissue reconstructions. These data suggest rhPDGF-BB may be a viable therapeutic strategy to augment the reconstruction of these complex defects by accelerating granulation, epithelialization, and wound closure.

Dynamics of Wound Healing in Patients With Obesity

Healing after dental surgery can vary from person to person. This study is being done to understand how body weight (obesity vs. normal weight) may affect healing after tissue is removed from the roof of the mouth during a gum graft procedure. The study will also evaluate whether a healing material made from a participant's own blood, called platelet-rich fibrin (PRF), is comparable in quantity and quality to the standard-of-care collagen plug. First, participants will be classified into obese or normal weight groups. Next, participants will be randomized to receive either collagen plug or platelet-rich fibrin clot during their surgical procedure Then, participants will return for 4 visits up to 30 days from the surgery visit.