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

NCT ID: NCT05946005

Last Updated: 2023-07-14

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 200 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-12-01
• Study Completion Date: 2022-05-31

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.

Conditions

Perineal Tear

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: FACTORIAL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Honey

Honey is referred to in the Qur'an as a wound healing agent (QS: 16:68 - 69) and has antimicrobial, antioxidant and anti-inflammatory effects. Honey, as an anti-inflammatory, has components of hydrogen peroxide, flavonoids, and phenolic acids that play a role in stimulating angiogenesis (8). Honey also has a high osmolality which provides moisture to the wound, thereby reducing edema and hyperemia and functioning as an antibacterial, so it is expected to reduce the use of antibiotics. Research reported in 2012 stated that honey had the same effect on wound healing and perineal wound pain in postpartum mothers with routine use two times a day for five days (P \< 0.05) (9).

Group Type: EXPERIMENTAL

honey

Intervention Type: DRUG

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

Lidocaine is used to reduce sensation in the tissues in certain areas. Lidocaine can be injected or applied topically, depending on the need. These topical anesthetics are popular due to their low cost and minimal side effects. The effect of lidocaine on wound healing is still controversial. A study showed the role of lidocaine in wound healing by significantly reducing wound tensile strength on day eight and increasing collagen maturation (7)

Group Type: EXPERIMENTAL

lidocaine

Intervention Type: DRUG

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

Povidone iodine is an antibacterial and anti-inflammatory agent that accelerates wound healing neovascularization. Several studies have used betadine in postpartum mothers with perineal rupture to provide faster wound healing. A study shows that povidone-iodine cream has a better absorption effect on the skin than betadine solution (10).

Group Type: EXPERIMENTAL

povidone-iodine

Intervention Type: DRUG

Betadine cream applied routinely to the wound two times a day for 14 days. BPOM (National Agency of Drug and Food Control) number: PKD20501710037

control groups

the control group were not given any intervention

Group Type: OTHER

control groups

Intervention Type: OTHER

no intervention is given

Interventions

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

Intervention Type: DRUG

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

Intervention Type: DRUG

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

Intervention Type: DRUG

control groups

no intervention is given

Intervention Type: OTHER

Other Intervention Names

Tresno Joyo honey; Dolones Cream; Betadine cream

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 40 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Hasanuddin University

OTHER

Sponsor Role: lead

Responsible Party

Maisuri Chalid

Head of Maternal Fetal Medicine Division, Department of Obstetrics and Gynecology

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Maisuri Chalid, Phd

Role: PRINCIPAL_INVESTIGATOR

Hasanuddin University

Locations

Wahidin Sudirohusodo Hospital

Makassar, South Sulawesi, Indonesia

Countries

Indonesia

Other Identifiers

UH21110729/2021

Identifier Type: -

Identifier Source: org_study_id