Lidocaine, Povidone Iodine, and Honey Application on Second-degree Perineal Tear Healing
Condition: Perineal Tear
Study type: Interventional
Phase: Phase 4

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.
    

Intervention name(s): honey; lidocaine; povidone-iodine; control groups
Intervention type(s): Drug; Drug; Drug; Other
Intervention description(s): 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; Dolones cream applied routinely to the wound two times a day for 14 days. BPOM (National Agency of Drug and Food Control) number: DKL0922246629AI; Betadine cream applied routinely to the wound two times a day for 14 days. BPOM (National Agency of Drug and Food Control) number: PKD20501710037; no intervention is given
Other intervention name(s): Tresno Joyo honey; Dolones Cream; Betadine cream
Intervention MeSH terms: Povidone-Iodine; Lidocaine; Povidone
Allocation: Randomized
Intervention model: Factorial Assignment
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.
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: perineal rupture; lidocaine; povidone-iodine; honey; wound healing; RCT