Clinical Research Directory

Influence of Sun Protection and Linear Repair of Cutaneous Surgical Defects

The purpose of this study is to determine the potential influence of sun protection on the aesthetic outcome of post-surgical scars following the reconstruction of Mohs micrographic surgery defects via linear repair. This study will be performed as a randomized split-wound study. Half of the wound will be treated with zinc containing sunscreen and the other half of the wound would not be treated. Three-months post-surgery, the scar will be evaluated via the patient observer scar assessment scale (POSAS), a validated scar instrument, as well as a colorimeter to measure the amount of vascularity, and hyperpigmentation between the treated and the non-treated area compared to the 'surrounding skin' defined as skin in the proximity but not adjacent to the wound. Any adverse events will also be recorded.

Pre-marketing Trial to Assess Safety and Efficacy of 'Volumizing Filler Based on Hyaluronic Acid and Recombinant Collagen'

Study to validate the safety and efficacy of the Hyaluronic Acid +Collagen filler 40 patients will undergo through 3 visits one to asses the health and apply the filler one after 4 weeks to check the results one after 16 weeks for the final check and results validation Safety assessed with analysis of the Adverse Events

Randomized Controlled Trial Examining the Efficacy of Botulinum Toxin in Biopsy Scar Minimization

The proposed study seeks to evaluate the scar reduction capacity of BTA on excision/biopsy wounds compared to the control (normal saline) in a double-blinded randomized control trial. It will expand upon previous studies that have already demonstrated the safety and good tolerance profile of BTA. We will be conducting a split-scar study/study involving two biopsy sites in a singular patient, allowing them to serve as their own control. In keeping with the results from previously conducted studies, we hypothesize that the wounds treated with BTA will have significantly less evidence of scar formation than those sites treated with normal saline.

Microneedling vs Dermabrasion for Early Facial Scar Resurfacing

This study aims to determine whether microneedling or dermabrasion in the early post-operative period is superior in improving the appearance of surgical scars on the face.

Effect of Myofascial Release Versus Deep Friction Massage on Abdominal Recovery and Scar After Cesarean Section

This study was done to compare the effect of myofascial release versus deep friction massage on abdominal recovery and scar after cesarean section.

Zinc Oxide Versus Petrolatum Following Skin Surgery

Patients undergoing routine surgery in the Department of Dermatology for any indication on non-scalp skin and closed in linear fashion with scar greater than or equal to 4.5cm in length will be invited to participate in this split scar, head to head study comparing zinc oxide and petrolatum. Patients will apply respective ointments to each half of scar daily for one month and maintain a log of these activities. They will be seen at 1 week, 4 weeks, 8 weeks, and 6 months post-operatively for photographic scar assessment and to complete the patient portion of the Patient and Observer Scar Assessment Scale (POSAS), a quantitative objective assessment of scar appearance. Trained observers (board-certified dermatologists) will score the observer portion of the scale. POSAS outcomes, post-operative infections, linear density of epidermal seal will be assessed at the 1 week, 4 weeks, 8 weeks, and 6 months post-operative periods and compared between the two groups. Participants will have parking validated for all visits and upon completion of all portions of the study will receive a standardized skin care gift bag containing samples for hypoallergenic skin care products (washes, moisturizers, etc.).

Impact of Suture Type on Pigment Disturbances in Patients of Skin of Color

The present study assesses if dissolvable (fast gut) or non-dissolvable (polypropylene) epidermal sutures produce better cosmetic results in terms of dyspigmentation and scarring in patients of skin of color. Through a split-wound study design, patients undergoing standard elliptical excisions at least 3 cm in length will receive each suture type. Measurements of dyspigmentation and scarring will be made at 7 days (for the head and neck), 10 days (for the trunk and extremities), and 3 months for all locations.

Paraffin Wax and Exercise Prospective

This study is being done to test if paraffin wax can be used to improve the range of motion and function for scars across joints when used in combination with scar rehabilitation therapy sessions. For those randomized to receive it, the paraffin wax will be used alongside the participants' exercise therapy treatments. Currently, treatments that are used in addition to rehabilitation therapy for increasing range of motion across joints in the burn population are limited. By getting more information about how paraffin wax may or may not work, patients in the future that have scars may be able to be helped.

CO2 Laser Revision for Burn Related Donor Site Scars

Scarring from burn wounds remains a chronic and often severe sequela of burn injury. Burn wounds may be left to heal by secondary intention or treated with surgical skin grafting; in both circumstances, significant scars likely result. When surgical skin grafting is employed, skin graft harvest sites ("donor sites") likewise result in clinically significant scars. This study will have interventional and observational components. Patients will receive the standard fractional ablative CO2 treatments to their scars resulting from burn wounds allowed to heal by secondary intention and/or those treated with skin grafts. These will be prospectively observed for the duration of the study as well as adjacent normal skin. In addition, a donor site that meets inclusion criteria that would not have otherwise received LSR will be identified as a treatment site. Patients with have one half of their donor sites randomized to standard of care (SOC) treatment, which consists of wound dressings, compression therapy, physical and occupational therapies and the other half randomized to SOC + ablative fractional CO2 laser therapy (LSR).

Preoperative Silicone Ointment and Wound Healing

Optimal scar healing is of great importance to patients, especially following surgery of the head and neck. This study evaluates the effectiveness of preoperative silicone ointment in wound healing in head and neck surgeries.

The Effects of Extracorporeal Shock Wave Therapy in Postsurgical Scars Especially After Abdominplasty and Breast Reduction.

Scars can be caused by physical trauma, surgical incisions, burn injuries and even acne. Deep cutaneous injuries induce pathological scars. Other factors, such as mechanical loading, bacterial colonization are potential factors thought to underlie human hypertrophic and keloid scar formation or contractures. The effect may include functional impairment and aesthetic disadvantages. Various non-invasive mechanical interventions of physical scar management (e.g. extracorporeal shock wave therapy or ESWT) could have a beneficial influence on wound healing and prevention of hypertrophic scars. ESWT considerably improves the appearance and symptoms of hypertrophic scars. However, the mechanism underlying the observed beneficial effects is not well understood. The objective of the first part of the study is to elucidate the mechanism underlying changes in cellular mechanosensitive pathways that are induced by ESWT. This review will introduce the histopathological effects on ESWT during wound healing and scar development. The main objective of this study is to determine how much mechanical loading on dermal scars will lead to normal scar healing. The optimal duration, the frequency and the intensity of the applied forces in ESWT to generate a beneficiary effect during different phases of wound healing remains unclear. In this study, biopsies from abdomionplasty postsurgical scars will be examined. Thereby it is possible to evaluate the outcomes on a cellular level through assessing the histology of human biopsies under controlled condition. In the second part, the underlying mechanism of ESWT on postsurgical scars will be explored, in different stages of wound healing. Furthermore, the investigators will investigate if changes in physical characteristics (redness, thickness and pliability) in postsurgical scars are associated with changes in reactivity of mechanosensitive pathways. This study will close the gap between the fundamental knowledge on cellular mechanotransduction and the clinical application of mechanotherapy during physical scar management (ESWT).

Silicone Taping for the Improvement of Abdominal Donor Site Scars

This study will look at silicone tape compared to the current no dressing standard at the investigators institution, to determine if silicone tape provides a significant improvement in post-abdominoplasty scar appearance. Silicone tape will be added to half of the abdominoplasty incision of patients undergoing abdominally-based breast reconstruction procedures two weeks after their operation. They will be followed up and assessed at specific timepoints to determine whether the silicone improves scar outcomes in these patients.

PDL and Fractional Photothermolysis for Postsurgical Scars

This is a two part study to evaluate the efficacy of early combined PDL (pulsed dye laser) and fractional photothermolysis in the cosmetic improvement of post surgical scars.All subjects will be offered at the time of the dermatologic procedure, an option to treat the post surgical scars with early combined PDL and fractional photothermolysis. Part A is a non-randomized study design and subjects will have the choice of whether or not they will receive treatment. In part B, subjects will be randomized in a 2:1 treatment vs. control design. The experimental group will have a total of 6 visits: 1 standard of care suture removal visit, 3 treatment visits and 2 follow up visits. The control group will have 3 visits: 1 standard of care suture removal visit and 2 follow up visits. Subjects currently living in the Chicago metropolitan area and meet inclusion/exclusion criteria will be considered for enrollment. This study is a pilot study designed to determine feasibility of this procedure.

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.

Infrared LED Lighting Application and Wound Healing

Laparoscopic cholecystectomy is a commonly used procedural procedure for removal of the gallbladder. Following this healing, wound healing, scar formation and scar tissue formation are critical factors in the healing process. The development of painless, noninvasive, biophysical therapeutic interventions has become the focus of current biomedical research. In recent years, it has been reported that infrared (IR) LED light applications have positive effects on tissue healing processes. This study will be conducted in a randomized controlled manner to examine the effect of postoperative IR LED application on wound healing, scarring and scar tissue formation in patients who underwent laparoscopic cholecystectomy.The research will be carried out at Erzurum City Hospital General Surgery Clinic between 15.08.2024-30.08.2025. A number sequence will be created for the 80 patients in the sample who meet the inclusion criteria for the experimental group and control group, and they will be assigned to the experimental (n = 40) and control groups (n = 40) using a computerized randomization program (https://www.random.org/integer-sets/) patient distribution will be provided. First of all, IR LED light application; It is applied on Post-Operative Day 1 and postoperative day 2. It will be given four times in total, from a distance of 45-60 cm, for 20 minutes at 8 hour intervals. On the 15th and 30th post-operative day, the patient will be asked to come to the hospital and the wound site will be re-evaluated and the data collection form will be filled out again. The patient's pain status will be evaluated with VAS, and satisfaction with Newcastle Nursing Care Satisfaction Scale. Wound and scar tissue will be examined with the Bates Jensen wound assessment scale and the patient and observer scar assessment scale. Wound and scar sites will be re-evaluated after the 15th and 30th post-operative day. The patient's pain status will be evaluated with VAS, and satisfaction with Newcastle Nursing Care Satisfaction Scale. Wound and scar tissue will be examined with the Bates Jensen wound assessment scale and the patient and observer scar assessment scale. The wound margin will be measured with a disposable ruler. In coding and evaluating the data; SPSS 22.00 package program will be used.

Effect of a Tele-rehabilitation Programme in Children With Burns: a Randomized Controlled Trial

The goal of this clinical trial is to compare tele-rehabilitation and routine post-discharge rehabilitation in children with burn injuries. The main questions it aims to answer are: * Is tele-rehabilitation better for improving the quality and outcomes of care for burn children? * Is tele-rehabilitation more effective in improving scar management in children with burns injuries? * Is tele-rehabilitation more effective in improving perceived stress in parents of children with burns injuries?

Dose Regimen Study of SLI-F06 in Healthy Volunteers

Multi-center, dose-regimen, double-blind study evaluating the safety and efficacy of 4 doses of SLI-F06 compared with vehicle for improvement in scar appearance

Partial Breast Versus no Irradiation for Women With Early Breast Cancer

All early breast cancer patients are offered adjuvant breast radiation therapy (RT) after breast conserving surgery for an early breast cancer. Breast cancer is heterogeneous, and selected patients have a very low gain from RT, whilst they still have risk of acute and late side effects from RT. This trial will try identify selection criteria for low risk breast cancer patients who can safely omit adjuvant RT without unacceptable high risk of local failure.

Tissue-engineered Skin Graft Repair of Autologous Scar Dermal Scaffolds

Hypertrophic scar is an inevitable outcome of wound repair. It affects the appearance and some scar contracture often leads to joint dysfunction.Patients have low quality of life, long treatment cycle, heavy social burden and high medical costs.Skin grafting is currently the gold standard for scar repair.However, there are often insufficient skin sources, easy to scar recurrence, lack of skin accessory organs.The application of composite skin graft can reduce the recurrence rate of scar healing and relieve the deficiency of skin source.However, its survival rate is not high, and acellular allogeneic dermal scaffolds are expensive, heavy medical burden.Therefore, how to effectively repair the wound surface after surgical excision of scar is the main problem to be solved urgently. Dermal loss is the main cause of unsatisfactory scar repair and recurrence.The previous clinical study of the research group found that the application of autologous epidermal basal cells and autologous skin graft obtained in real time during the operation could effectively improve the survival rate of skin graft in the treatment of wound surface (Brit J Surg, 2015).Furthermore, it is suggested that the application of autologous scar dermal scaffolds can achieve the control of skin damage in the skin harvesting area and the orthotopic transplantation of autologous scar tissue dermal scaffolds, which can effectively reduce the economic burden of patients.Therefore, the researchers wondered whether the construction of tissue-engineered skin orthotopic transplantation with autologous epidermal basal cells and autologous scar dermal scaffold combined with autologous scar dermal scaffolds to repair the wound after scar resection could improve the survival rate of skin graft and reduce scar recurrence.To this end, we plan to carry out multi-center, prospective, randomized, controlled clinical trials, aiming at proposing more effective surgical treatment guidelines for the repair of hypertrophic scar, improving the survival rate of composite skin graft, and solving the current clinical problems of hypertrophic scar repair.