Depth of Necrosis in Normal Cervical Epithelium After 85% Trichloroacetic Acid (TCA) Application
NCT ID: NCT04911075
Last Updated: 2021-12-02
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
NA
40 participants
INTERVENTIONAL
2021-04-15
2021-10-25
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
According to a study in the US (1982), as many as 99.7% of CIN-III cases had a lesion depth of less than 4.8 millimeter. Furthermore, a Netherlands study (1990) stated that as many as 99.7% of CIN-III cases had a maximum lesion depth of 3.6 millimeters. While in subjects from developing countries, study from Peru (2018) showed that 93.5% of CIN-III cases have a lesion depth of less than 5 millimeters. Based on the results of these studies, a treatment for CIN can only be said to be effective if it can create a therapeutic effect which can reach depths of 4-5 millimeters in cervix epithelial.
Trichloroacetic acid (TCA) is an acetic acid analogue, which has long been known as a chemical peel and also frequently used to treat genital ward and precancerous skin lesions. The effect of TCA therapy is the destruction of the epithelium forming epithelial necrosis, followed by re-epithelialization of the supporting tissue and stimulation of collagen synthesis within approximately in 24 hours. There are no studies regarding the depth of cervical necrosis that can be achieved by application of this solution to the cervix epithelial.
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
The purpose of this study is to determine the depth of epithelial necrosis in cervical tissue specimen after 85 percent TCA application on clinically normal cervix.
Procedure:
Patients will receive a single administration of 1-2 milliliter of 85 percent TCA in 24 hours before elective total hysterectomy surgery on indication other than cervical pathology. The 85 percent TCA will be applied topically onto the ectocervix and the endocervix canal with a cotton swab for 1-2 minutes. After surgery, cervical specimen will be fixated in formalin and sent for histopathologic examination.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Keywords
Explore important study keywords that can help with search, categorization, and topic discovery.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
85% TCA Group
* Participants are subject who will undergo an elective total hysterectomy procedure for indications of gynecological organ abnormalities, whether benign, pre-cancerous, or malignant other than cervical pathology.
* The 85 percent TCA solution will be applied to participants cervical tissue 24 hours before surgery.
85% TCA Solution
* TCA is an acetic acid analogue solution (CCl3COOH) which is formed from the reaction of acetic acid (CH3COOH) with chlorine (3Cl2).
* High concentrations (85 percent) of this solution can penetrate deeply into the epidermis-dermis layer and cause cells necrosis.
* This solution (1-2 milliliter) will be applied to participants cervical tissue (ectocervix and endocervix) using cotton swab for 1-3 minutes.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
85% TCA Solution
* TCA is an acetic acid analogue solution (CCl3COOH) which is formed from the reaction of acetic acid (CH3COOH) with chlorine (3Cl2).
* High concentrations (85 percent) of this solution can penetrate deeply into the epidermis-dermis layer and cause cells necrosis.
* This solution (1-2 milliliter) will be applied to participants cervical tissue (ectocervix and endocervix) using cotton swab for 1-3 minutes.
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* Participants are willing to participate voluntarily in this research by signing a consent form.
Exclusion Criteria
* Any abnormalities found in postoperative cervical histopathology results.
18 Years
65 Years
FEMALE
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Dr Cipto Mangunkusumo General Hospital
OTHER
Indonesia University
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Prof. Dr. dr. Laila Nuranna, SpOG-K
Professor
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Laila Nuranna, Professor
Role: PRINCIPAL_INVESTIGATOR
Indonesia University
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
dr. Cipto Mangunkusumo National Central General Hospital
Jakarta, , Indonesia
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
Boonstra H, Aalders JG, Koudstaal J, Oosterhuis JW, Janssens J. Minimum extension and appropriate topographic position of tissue destruction for treatment of cervical intraepithelial neoplasia. Obstet Gynecol. 1990 Feb;75(2):227-31.
Abdul-Karim FW, Fu YS, Reagan JW, Wentz WB. Morphometric study of intraepithelial neoplasia of the uterine cervix. Obstet Gynecol. 1982 Aug;60(2):210-4.
Taxa L, Jeronimo J, Alonzo TA, Gage J, Castle PE, Cremer ML, Felix JC. Depth of Cervical Intraepithelial Neoplasia Grade 3 in Peruvian Women: Implications for Therapeutic Depth of Necrosis. J Low Genit Tract Dis. 2018 Jan;22(1):27-30. doi: 10.1097/LGT.0000000000000355.
Brodland DG, Cullimore KC, Roenigk RK, Gibson LE. Depths of chemexfoliation induced by various concentrations and application techniques of trichloroacetic acid in a porcine model. J Dermatol Surg Oncol. 1989 Sep;15(9):967-71. doi: 10.1111/j.1524-4725.1989.tb03183.x.
Mariategui J, Santos C, Taxa L, Jeronimo J, Castle PE. Comparison of depth of necrosis achieved by CO2- and N2O-cryotherapy. Int J Gynaecol Obstet. 2008 Jan;100(1):24-6. doi: 10.1016/j.ijgo.2007.07.009. Epub 2007 Sep 25.
Adepiti AC, Ajenifuja OK, Fadahunsi OO, Osasan SA, Pelemo OE, Loto MO. Comparison of the depth of tissue necrosis between double-freeze and single-freeze nitrous oxide-based cryotherapy. Niger Med J. 2016 Jan-Feb;57(1):1-4. doi: 10.4103/0300-1652.180561.
Geisler S, Speiser S, Speiser L, Heinze G, Rosenthal A, Speiser P. Short-Term Efficacy of Trichloroacetic Acid in the Treatment of Cervical Intraepithelial Neoplasia. Obstet Gynecol. 2016 Feb;127(2):353-9. doi: 10.1097/AOG.0000000000001244.
Walker DC, Brown BH, Blackett AD, Tidy J, Smallwood RH. A study of the morphological parameters of cervical squamous epithelium. Physiol Meas. 2003 Feb;24(1):121-35. doi: 10.1088/0967-3334/24/1/309.
Provided Documents
Download supplemental materials such as informed consent forms, study protocols, or participant manuals.
Document Type: Statistical Analysis Plan
Document Type: Informed Consent Form
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
21020134
Identifier Type: -
Identifier Source: org_study_id