Clinical trial NCT05946005: Lidocaine, Povidone Iodine, and Honey Application on Second-degree Perineal Tear Healing
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Perineal Tear
Keywords: perineal rupture
lidocaine
povidone-iodine
honey
wound healing
RCT
Lead sponsor: Hasanuddin University
Sponsor class: OTHER
First posted: 2023-07-14
Enrollment: 200
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Intervention model description: This study was a single-blind randomized control trial conducted at five different hospitals in Makassar from December 2021 to May 2022. All mothers with vaginal delivery who experienced grade II perineal rupture were applied lidocaine cream, povidone iodine cream, honey, and controls, measured on the REEDA and visual analogue scales (VAS) and observed on days 0, 1, 3, 5, 7, and 14. Repeated ANOVA or Friedman tests were used to analyze the data obtained.
Primary purpose: TREATMENT

Brief 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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Correlation of the Effectiveness of Wound Healing using honey, lidocaine, povidone - iodine and control with the total REEDA ( Redness, Oedema, Ecchymosis, Discharge, Approximation)
timeFrame: 0 - 14 days
measure: Correlation of the Effectiveness of Wound Healing using honey, lidocaine, povidone - iodine and control with Redness from REEDA scale
timeFrame: 0 - 14 days
measure: Correlation of the Effectiveness of Wound Healing using honey, lidocaine, povidone - iodine and control with Edema from REEDA scale
timeFrame: 0 - 14 days
measure: Correlation of the Effectiveness of Wound Healing using honey, lidocaine, povidone - iodine and control with ecchymosis from REEDA scale
timeFrame: 0 - 14 days
measure: Correlation of the Effectiveness of Wound Healing using honey, lidocaine, povidone - iodine and control with discharge from REEDA scale
timeFrame: 0 - 14 days
measure: Correlation of the Effectiveness of Wound Healing using honey, lidocaine, povidone - iodine and control with approximation from REEDA scale
timeFrame: 0 - 14 days
Secondary outcomes:
measure: Correlation of the Effectiveness of Reducing Pain Degrees using honey, lidocaine, povidone - iodine and control with the VAS (Visual Analogue Scale)
timeFrame: 0 - 14 days
measure: 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)
timeFrame: 0 - 14 days
Other outcomes:
measure: Age characteristics of study participants
timeFrame: 0 - 14 days
measure: Parity characteristics of study participants
timeFrame: 0 - 14 days
measure: Body mass index characteristics of study participants
timeFrame: 0 - 14 days
measure: Blood pressure characteristics of study participants
timeFrame: 0 - 14 days
measure: Anemia characteristics of study participants
timeFrame: 0 - 14 days
measure: Episiotomy characteristics of study participants
timeFrame: 0 - 14 days
measure: Birth weight characteristics of study participants
timeFrame: 0 - 14 days
measure: Perineal rupture history characteristics of study participants
timeFrame: 0 - 14 days
Locations:
city: Makassar
country: Indonesia
facility: Wahidin Sudirohusodo Hospital
state: South Sulawesi
Study officials:
affiliation: Hasanuddin University
name: Maisuri Chalid, Phd
role: PRINCIPAL_INVESTIGATOR
References: