Lidocaine, Povidone Iodine, and Honey Application on Second-degree Perineal Tear Healing

Perineal Tear Clinical Trial

Official title:

Effectiveness of Continuous Application of Lidocaine Cream, Povidone Iodine Cream, and Honey on Second-degree Perineal Tear Healing, a Randomized Controlled Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05946005
• Other study ID #: UH21110729/2021
• Status: Completed
• Phase: Phase 4
• Start date: December 1, 2021
• Est. completion date: May 31, 2022

Study information

• Verified date: July 2023
• Source: Hasanuddin University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This clinical trial aims to compare the effectiveness of the continuous application of lidocaine cream, honey, and povidone-iodine cream in second-degree perineal tear healing.

The main question[s] it aims to answer are:

• Which one has better pain relief effectiveness among the three regimens (lidocaine, povidone-iodine, and honey) as measured by the VAS scale

• Which has better wound healing effectiveness among the three regimens as measured by the REEDA scale The study population was postpartum mothers with second-degree perineal rupture who performed vaginal deliveries and sutured perineal ruptures. Each subject will be provided one of the three applications (lidocaine, povidone-iodine, and honey) to be given to their perineal wound.

Description:

The sample size was calculated using the formulation for comparative study with power 1 - β = 0.8, two-tail α = 0.05, a mean of the standard deviation of 1.265, and a minimum mean difference of 0.3. The required sample size was 140 sample of labor women (35 samples in each group).

Research subjects included as many as 220 subjects. A total of 215 subjects met the inclusion criteria, consisting of 4 groups based on the type of perineal wound treatment: the group smeared with honey, lidocaine cream, povidone iodine cream, and the control group. There were 5 research subjects who did not meet the criteria, namely: 2 subjects experienced postpartum hemorrhage, 1 subject had a vulvar hematoma and was re-stitched, and 2 subjects were not willing to participate in the study. All study subjects were measured on the REEDA and VAS scales and observed on days 0, 1, 3, 5, 7, and 14. During the observation, 10 subjects could not be followed up further. The research subjects analyzed consisted of honey (n = 50), lidocaine cream (n = 50), povidone-iodine cream (n = 50), and controls (n = 50).

Initially, all participants were assessed for the severity of the wound due to their perineal tear and the VAS pain scale. After that, continuous suturing of the perineum was carried out with Chromic absorbable thread no.2.0 by a competent obstetrician resident according to operational standards. All women with perineal sutures were given ten tablets of paracetamol 500 mg 3 times daily, not antibiotics. After 30 minutes to 1 hour of perineal suturing, the subjects were divided into four groups, each group of at least 50 people was given simple randomized treatment (ratio 1:1:1:1). Each treatment group, i.e. lidocaine cream (Dolones Cream, Sanbe Farma, Indonesia), honey (Madu TJ, Tresno Joyo, Indonesia), povidone-iodine cream (Betadine, Mundi Pharma, Indonesia), and the control group were not given any intervention were applied routinely to the wound two times a day for 14 days and monitored on days 0, 1, 3, 5, 7, and 14. The parameters monitored were the wound healing process and pain scale using the REEDA scale (30 cm ruler) and visual analogue scale (VAS), respectively. The single-blinded method was used to minimize bias. All subjects were given a choice of four closed tubes of different colours, each filled with honey, lidocaine cream and povidone-iodine cream, then given instructions for use by applying twice daily. Monitoring is carried out by providing monitoring cards and being followed daily.

Subjects were taught how to apply it by washing their hands first, then applying it to all perineal wounds. Research subjects were asked to report all complaints and side effects that were felt. All subjects have explained the purpose of the research and confidentiality in data management.

The data were coded, entered, and analyzed using Microsoft Excel 2010 and Statistical Package for the Social Science version 16.0 (SPSS Inc; Chicago, IL, USA). The statistical test used is the ANOVA test if the data is normally distributed or the Kruskal Wallis test if the data is not normally distributed. These two tests were used to compare the three treatment groups. To see the changes in each group, a repeated ANOVA test was used if the data were normally distributed or the Friedman test if the data were not. These tests are used if repeated observations are made more than two times. To find out the normality of the data using the Kolmogorov-Smirnov test. P-value < 0.05 was considered statistically significant. The analyzed data will then be presented as frequency tables, cross-tabulation tables, graphs, and narratives for interpretation and discussion.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 200
• Est. completion date: May 31, 2022
• Est. primary completion date: April 15, 2022
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 40 Years

Eligibility

Inclusion Criteria:

• Willing to participate in research activities and policy research approval letter.

• Post-partum mothers with second-degree perineal rupture who underwent perineal suturing with episiotomy or spontaneous rupture.

Exclusion Criteria:

• Patients with a history of autoimmunity, cancer, systemic infection, or infection.

• Mother using antibiotics

Related Conditions & MeSH terms

• Perineal Tear

Intervention

Drug:
• honey
Tresno Joyo honey applied routinely to the wound two times a day for 14 days. BPOM (National Agency of Drug and Food Control) number: MD252109001219
• lidocaine
Dolones cream applied routinely to the wound two times a day for 14 days. BPOM (National Agency of Drug and Food Control) number: DKL0922246629AI
• povidone-iodine
Betadine cream applied routinely to the wound two times a day for 14 days. BPOM (National Agency of Drug and Food Control) number: PKD20501710037

Other:
• control groups
no intervention is given

Locations

Country	Name	City	State
Indonesia	Wahidin Sudirohusodo Hospital	Makassar	South Sulawesi

Sponsors (1)

Lead Sponsor	Collaborator
Hasanuddin University

Country where clinical trial is conducted

Indonesia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Age characteristics of study participants	Age is a measurement of how long individual has lived. In this research, age is classified into several categories. Data is presented in ordinal scale over 3 categories: < 20 years old, 20 - 35 years old, and > 35 years old.	0 - 14 days
Other	Parity characteristics of study participants	Parity is a measurement of how many times has an individual given birth. In this research, parity is classified into several categories. Data is presented in categorical scale over 3 categories: primipara (once), multiparous (2-5 times), grand multiparous (> 5 times).	0 - 14 days
Other	Body mass index characteristics of study participants	Body mass index is a measurement to assess the nutritional status of an individual. In this research, body mass index is classified into several categories. Data is presented in categorical scale over 2 categories: normal (18.5 - 24.9 kg/m2) and overweight (> 24.9 kg/m2). The classification of the body mass index is accordance with World Health Organization's classification for Asian population.	0 - 14 days
Other	Blood pressure characteristics of study participants	Blood pressure is a measurement of the pressure of blood pumped in the human body. In this research, blood pressure is classified into several categories. Data is presented in categorical scale over 2 categories: normotension (systolic BP < 140 mmHg and/or diastolic BP < 90 mmHg) and hypertension (systolic BP >= 140 mmHg and/or diastolic BP >= 90 mmHg)	0 - 14 days
Other	Anemia characteristics of study participants	Anemia is a condition where hemoglobin concentration is lower than normal. In this research, anemia is classified into several categories. Data is presented in categorical scale over 3 categories: mild (hemoglobin 10.0 grams/dL to 12.0 grams/dL), moderate (hemoglobin 8.0 - 9.9 grams/dL), and normal (hemoglobin > 12.0 grams/dL).	0 - 14 days
Other	Episiotomy characteristics of study participants	Episiotomy is a surgical incision of the perineum and the posterior vaginal wall. In this research, we classify patients whether or not they have undergone the procedure of episiotomy. Data is presented in categorical scale over 2 categories: yes (episiotomy performed) and no (episiotomy not performed).	0 - 14 days
Other	Birth weight characteristics of study participants	The weight of the babies delivered. In this research, birth weight is classified into several categories. Data is presented in categorical scale over 2 categories: < 2500 grams, and 2500-4000 grams.	0 - 14 days
Other	Perineal rupture history characteristics of study participants	The history whether or not an individual has a history of perineal rupture. Data is presented in categorical scale over 2 categories: yes (a history of perineal rupture was noted) and no (a history of perineal rupture was not noted).	0 - 14 days
Primary	Correlation of the Effectiveness of Wound Healing using honey, lidocaine, povidone - iodine and control with the total REEDA ( Redness, Oedema, Ecchymosis, Discharge, Approximation)	REEDA scale is a tool that assesses the inflammatory process and tissue healing in perineal trauma. Total REEDA scale is calculated and presented, without emphasizing the evaluation of one of the components, namely redness, edema, ecchymosis, discharge, and approximation. Data is presented in numerical scale (0-15). The greater the score is, the less likely the wound appear to heal.	0 - 14 days
Primary	Correlation of the Effectiveness of Wound Healing using honey, lidocaine, povidone - iodine and control with Redness from REEDA scale	This outcome measures only the redness scale on the REEDA scale. Data is presented in numerical scale (0-3). The greater the score is, the more severe the condition is.	0 - 14 days
Primary	Correlation of the Effectiveness of Wound Healing using honey, lidocaine, povidone - iodine and control with Edema from REEDA scale	This outcome measures only the edema scale on the REEDA scale. Data is presented in numerical scale (0-3). The greater the score is, the more severe the condition is.	0 - 14 days
Primary	Correlation of the Effectiveness of Wound Healing using honey, lidocaine, povidone - iodine and control with ecchymosis from REEDA scale	This outcome measures only the ecchymosis scale on the REEDA scale. Data is presented in numerical scale (0-3). The greater the score is, the more severe the condition is.	0 - 14 days
Primary	Correlation of the Effectiveness of Wound Healing using honey, lidocaine, povidone - iodine and control with discharge from REEDA scale	This outcome measures only the discharge scale on the REEDA scale. Data is presented in numerical scale (0-3). The greater the score is, the more severe the condition is.	0 - 14 days
Primary	Correlation of the Effectiveness of Wound Healing using honey, lidocaine, povidone - iodine and control with approximation from REEDA scale	This outcome measures only the approximation scale on the REEDA scale. Data is presented in numerical scale (0-3). The greater the score is, the more severe the condition is.	0 - 14 days
Secondary	Correlation of the Effectiveness of Reducing Pain Degrees using honey, lidocaine, povidone - iodine and control with the VAS (Visual Analogue Scale)	VAS is one of the scales that can be used to assess subjective pain presented by an individual. Data is presented in numerical scale (0-10). The greater the score is, the more pain an individual subjectively suffers.	0 - 14 days
Secondary	Correlation of the Effectiveness of Decreasing the REEDA Scale and the VAS Scale at the beginning and end of the follow up (all treatment groups: honey, lidocaine, povidone - iodine and control)	Mean total of REEDA and VAS scales in all treatment group were evaluated and compared at the start and end of follow-up of each individual. Data is presented in numerical scale.	0 - 14 days