Infrared LED Lighting Application and Wound Healing

NCT06533072 | Recruiting

• 1 other identifier: arasuymazgulistan
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Cholecystectasia; Wound Heal; Scar

Keywords

surgical wound; Photobiomodülation; Ligh; Therapy

Outcome Measures

Primary Outcomes (2)

• wound healing

  To accelerate wound healing with postoperative infrared LED light application

  1 month

• Scar Tıssue Formatıon

  scars can create functional problems for patients. It is aimed to provide a more cosmetic and aesthetic appearance by preventing scar formation.

  one month

Secondary Outcomes (1)

• physiological parameter

  one month

Study Arms (2)

experimental group

EXPERIMENTAL

Patients who received routine medical treatment and nursing care + IR LED Light application after surgery (n = 40). It is applied on Post-Operative Day 1-2. It will be given four times in total, from a distance of 45-60 cm, for 20 minutes at 8 hour intervals (Wolters and Feaarnly, 2023). The patient will be asked to remain in the supine position during the procedure and the patient's vital signs will be checked again after the procedure. After the third and last Infrared LED application on post-op Day 2, the patient's wound was re-evaluated and the wound was dressed and closed. 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.

Other: The group receiving infrared LED therapy

Control group

NO INTERVENTION

This is the group of patients who received routine medical treatment and nursing care after surgery (n=40). After the patient's vital signs were taken postoperative one day and after the Informed Consent Form was obtained from patients who met the inclusion criteria and volunteered to participate in the study; Data collection form (demographic information form, Bates-Jensen wound assessment scale, observer scar assessment scale, VAS, Newcastle Nursing Care Satisfaction Scale) will be filled out.

Interventions

The group receiving infrared LED therapy OTHER

Patients in this group are the ones who will be exposed to IR LED light therapy, three times in total

Also known as: experimental group

experimental group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Ardahan University: lead

Study Sites (1)

Atatürk Universty

Erzurum, State, 25000, Turkey (Türkiye)

RECRUITING

MeSH Terms

Conditions

Cicatrix; Surgical Wound

Condition Hierarchy (Ancestors)

Fibrosis; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Wounds and Injuries

Study Officials

• Zeynep Karaman Özlü, PhD

  Atatürk Universty

  STUDY DIRECTOR

Central Study Contacts

Gülistan Uymaz Aras

CONTACT

905392016550; uymazgulistan@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: lecturer

Study Record Dates

• First Submitted: July 22, 2024
• First Posted: August 1, 2024
• Study Start: June 15, 2024
• Primary Completion: August 15, 2025
• Study Completion: December 30, 2025
• Last Updated: August 1, 2024

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)