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

NCT05946005 | Completed Phase 4

• 1 other identifier: UH21110729/2021
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

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.

Conditions

Perineal Tear

Keywords

perineal rupture; lidocaine; povidone-iodine; honey; wound healing; RCT

Outcome Measures

Primary Outcomes (6)

• 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

• 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

• 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

• 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

• 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

• 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 Outcomes (2)

• Correlation of the Effectiveness of Reducing Pain Degrees using honey, lidocaine, povidone - iodine and control with the VAS (Visual Analogue Scale)

  0 - 14 days

• 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)

  0 - 14 days

Other Outcomes (8)

• Age characteristics of study participants

  0 - 14 days

• Parity characteristics of study participants

  0 - 14 days

• Body mass index characteristics of study participants

  0 - 14 days

Study Arms (4)

Honey

EXPERIMENTAL

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).

Drug: honey

Lidocaine

EXPERIMENTAL

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)

Drug: lidocaine

povidone - iodine

EXPERIMENTAL

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).

Drug: povidone-iodine

control groups

OTHER

the control group were not given any intervention

Other: control groups

Interventions

honey 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

Also known as: Tresno Joyo honey

Honey

lidocaine 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

Also known as: Dolones Cream

Lidocaine

povidone-iodine 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

Also known as: Betadine cream

povidone - iodine

control groups OTHER

no intervention is given

control groups

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Hasanuddin University: lead

Study Sites (1)

Wahidin Sudirohusodo Hospital

Makassar, South Sulawesi, 90245, Indonesia

Location

MeSH Terms

Interventions

Honey; Lidocaine; Povidone-Iodine; Control Groups

Intervention Hierarchy (Ancestors)

Food; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages; Acetanilides; Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines; Iodophors; Iodine Compounds; Inorganic Chemicals; Polyvinyls; Vinyl Compounds; Alkenes; Hydrocarbons, Acyclic; Hydrocarbons; Povidone; Pyrrolidinones; Pyrrolidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Plastics; Polymers; Macromolecular Substances; Biomedical and Dental Materials; Manufactured Materials; Technology, Industry, and Agriculture; Epidemiologic Research Design; Epidemiologic Methods; Investigative Techniques; Research Design; Methods

Study Officials

• Maisuri Chalid, Phd

  Hasanuddin University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head of Maternal Fetal Medicine Division, Department of Obstetrics and Gynecology

Model Details: 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.

Study Record Dates

• First Submitted: May 25, 2023
• First Posted: July 14, 2023
• Study Start: December 1, 2021
• Primary Completion: April 15, 2022
• Study Completion: May 31, 2022
• Last Updated: July 14, 2023

Record last verified: 2023-07

Data Sharing

• IPD Sharing: Will not share

Locations

ID (1)