The Effect Of Infrared Led Lıght Applıcatıon On Wound Healıng, Scar And Scar Tıssue Formatıon In Patıents Havıng Laparascopıc Cholesystectomy Surgery
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 80
- 试验地点
- 2
- 主要终点
- Scar Tıssue Formatıon
研究概览
简要总结
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.
详细描述
1. Introduction 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. There are countless wounds; 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. IR LED red light application has recently become a widely preferred method due to its ease of application, easy access, no need for expertise for application, and the ability of individuals to apply it at home or anywhere they want. The ability of light to penetrate a tissue and accumulate energy through the tissue's optical absorption properties is key to therapeutic applications. When electromagnetic radiation strikes biological tissue, different interactions occur as a function of various physical parameters. In the medical field, red and near-light induced IR LED (Low Energy Light) application (therapy) is known for its abilities to promote wound healing, reduce inflammation, reduce pain, and positively modulate biochemical and molecular chemicals. Although the light-tissue interaction depends primarily on wavelength, it is also affected by the tissue components that interact with the photons. In tissue, an 'optical window' lies between 600 and 1350 nm. Light with a wavelength smaller or larger than this region is absorbed by tissue components (hemoglobin, myoglobin in the visible region and tissue water content in the IR region). Additionally, biological tissue has a lower scattering capacity in the NIR region than in the visible region. This means that biological experiments in this range can be performed without damaging skin tissue. This has led to the emergence of new hopes for the destruction of microorganisms on the skin before they develop resistance, providing painless treatment with light-based treatments, and chronic wound healing. Although the wound area is minimal in patients who undergo cholecystectomy by laparoscopy method, the healing time of the wound varies between 3 weeks and 8 weeks and this period may be longer depending on the condition of the individual. The location of the wound in the abdomen restricts the patient's movements and leaves a scar in the abdomen. This situation negatively affects the patient psychologically and socially. In the study, patients who underwent minimally invasive surgery were selected because they provide a better opportunity to observe the wound site, as external factors can be more easily controlled, the hospitalization period, infection and other physical complications are less likely. Therefore, the smaller the wound area, the easier the wound can be closed and the scar can be seen more quickly, making it easier to work. In patients who undergo surgery with minimal laparoscopy, the postoperative care protocol is more focused on medical treatment and long-term effects are ignored. Our study offers a different postoperative care protocol for patients undergoing minimally invasive surgery. There is no certainty in the literature regarding the duration and intervals of LED application to the wound site. Kim et all applied light with 660 wavelengths at different distances to the wound site once and reported that application for 10 minutes better increased the activity at the cell level. In a different study, it was found that two applications were made instead of the incision after cesarean section surgery, but no clear information was found in the study about the number of hours between applications. In the study, the wound site was evaluated on the 3rd day before the patient was discharged. In a case report reported by Vinck et all a male patient who had an operation on his foot applied light at a wavelength of 950 nm to the 6 cm incision. The evaluation was made 6 days later. It was reported that there was less color change and less scarring in the 2.6 cm area. It is planned to perform a control evaluation on the 15th and 30th days post-op to compare the thickness of the scar tissue and the change in the wound site. During the research process, patients' wound healing will be observed, scar formation will be evaluated, and scar tissue formation will be examined. Various ancillary parameters will also be recorded, including patient satisfaction, pain levels, and other factors in the healing process. The results of this research will reveal the potential effects of IR LED light application on wound healing, scar formation, and scar tissue formation after laparoscopic cholecystectomy. These findings are important for developing new treatment strategies to optimize post-surgical recovery processes. The findings may offer clinicians new perspectives on optimizing patient care after surgical intervention. The following hypotheses will be tested in the research.
Ho: Application of IR LED light to the wound site has no effect on wound healing.
H1: Application of IR LED light to the wound site has a positive effect on wound healing.
Methods Type of Research 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.
Place and Time of Research The research will be carried out at Erzurum City Hospital General Surgery Clinic between 30.06.2024-30.08.2025.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Prevention
- 盲法
- Single (Investigator)
入排标准
- 年龄范围
- 18 Years 至 65 Years(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •being over 18 years and under 65 years old
- •Volunteer to participate in the study
- •Having cognitive competence
- •Absence of any chronic disease (diabetes, COPD, hypertension, etc.)
- •Not Separating the Wound
- •Tympanic body temperature; 35.7-37.5; axillary; It should be between 36.5 and 37.0
排除标准
- •Presence of signs and symptoms of infection at the wound site
- •Unusual bleeding at the wound site
- •Patients are given hypertensive, anticoagulant, thyroid etc. starting medications
结局指标
主要结局
Scar Tıssue Formatıon
时间窗: one month
scars can create functional problems for patients. It is aimed to provide a more cosmetic and aesthetic appearance by preventing scar formation.
wound healing
时间窗: 1 month
To accelerate wound healing with postoperative infrared LED light application
次要结局
- physiological parameter(one month)
研究者
Gülistan UYMAZ ARAS
lecturer
Ardahan University
