Perineal TearPhase 4NCT05946005
Lidocaine, Povidone Iodine, and Honey Application on Second-degree Perineal Tear Healing
A Phase 4 study testing honey, lidocaine and povidone-iodine in people with Perineal Tear, run by Hasanuddin University at 1 site in Indonesia.
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… Read more about this study
- Who is it for?
- Ages 18 to 40 years, women only
- Conditions the study is for
- Perineal Tear
- What is being tested?
- honey, lidocaine and povidone-iodine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteIndonesia
- Study dates
- 1 Dec 2021to 31 May 2022
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 40 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- 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.
Who cannot join
- Patients with a history of autoimmunity, cancer, systemic infection, or infection.
- Mother using antibiotics
Trial locations and contacts
1 site in 1 country.
Indonesia1 site
Wahidin Sudirohusodo Hospital
Makassar, South Sulawesi, 90245
About this study
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
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.
Read the 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
- Being tested
- honey, lidocaine, povidone-iodine, control groups
- Keywords
- perineal rupture, lidocaine, povidone-iodine, honey, wound healing, RCT
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
honeyDrug
Also called Tresno Joyo 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
lidocaineDrug
Also called Dolones Cream
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-iodineDrug
Also called Betadine cream
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 groupsOther
no intervention is given
| Study group | Role | What they receive |
|---|---|---|
| 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). Receives: 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) Receives: 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). Receives: Drug: povidone-iodine |
| control groups | Other | the control group were not given any intervention Receives: Other: control groups |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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)
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.
Measured: 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)
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.
Measured: 0 - 14 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jul 2023
- Study start1 Dec 2021
- Primary completion15 Apr 2022
- Study completion31 May 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Perineal TearStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- 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 blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 200 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hasanuddin University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Maisuri Chalid, Hasanuddin University
- Investigators
- Maisuri Chalid, Phd, Principal investigator, Hasanuddin University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05946005
- Sponsor's protocol ID
- UH21110729/2021
- Status last verified
- Jul 2023
- First submitted
- 25 May 2023
- Last updated
- 14 Jul 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Because this study has been finished
Study at a glance
From the registry record, last updated by the sponsor on 14 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05946005
- Acronym / sponsor ID
- UH21110729/2021
- Conditions
- Perineal Tear
- Keywords
- perineal rupture, lidocaine, povidone-iodine, honey, wound healing, RCT
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 200 participants (actual)
- Lead sponsor
- Hasanuddin UniversityUniversity, hospital or other
- Study start
- 1 Dec 2021 (actual)
- Primary completion
- 15 Apr 2022 (actual)
- Study completion
- 31 May 2022 (actual)
- First posted
- 14 Jul 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
- 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.
| Arm | Type | Receives |
|---|---|---|
| Honey | Experimental | Drug: honeyHoney 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). |
| Lidocaine | Experimental | Drug: lidocaineLidocaine 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) |
| povidone - iodine | Experimental | Drug: povidone-iodinePovidone 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). |
| control groups | Other | Other: control groupsthe control group were not given any intervention |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (2 listed)
- Patients with a history of autoimmunity, cancer, systemic infection, or infection.
- Mother using antibiotics
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| honeyAlso: Tresno Joyo honeyTresno Joyo honey applied routinely to the wound two times a day for 14 days. BPOM (National Agency of Drug and Food Control) number: MD252109001219 | Drug | Honey |
| lidocaineAlso: Dolones CreamDolones cream applied routinely to the wound two times a day for 14 days. BPOM (National Agency of Drug and Food Control) number: DKL0922246629AI | Drug | Lidocaine |
| povidone-iodineAlso: Betadine creamBetadine cream applied routinely to the wound two times a day for 14 days. BPOM (National Agency of Drug and Food Control) number: PKD20501710037 | Drug | povidone - iodine |
| control groupsno intervention is given | Other | control groups |
Primary outcome
Correlation of the Effectiveness of Wound Healing using honey, lidocaine, povidone - iodine and control with the total REEDA ( Redness, Oedema, Ecchymosis, Discharge, Approximation)
Time frame: 0 - 14 days
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.
Correlation of the Effectiveness of Wound Healing using honey, lidocaine, povidone - iodine and control with Redness from REEDA scale
Time frame: 0 - 14 days
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.
Correlation of the Effectiveness of Wound Healing using honey, lidocaine, povidone - iodine and control with Edema from REEDA scale
Time frame: 0 - 14 days
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.
Correlation of the Effectiveness of Wound Healing using honey, lidocaine, povidone - iodine and control with ecchymosis from REEDA scale
Time frame: 0 - 14 days
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.
Correlation of the Effectiveness of Wound Healing using honey, lidocaine, povidone - iodine and control with discharge from REEDA scale
Time frame: 0 - 14 days
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.
Correlation of the Effectiveness of Wound Healing using honey, lidocaine, povidone - iodine and control with approximation from REEDA scale
Time frame: 0 - 14 days
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.
2 secondary outcomes
Correlation of the Effectiveness of Reducing Pain Degrees using honey, lidocaine, povidone - iodine and control with the VAS (Visual Analogue Scale)
Time frame: 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)
Time frame: 0 - 14 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jul 2023.
- Individual participant dataSharing planned: No. Because this study has been finished
Related trials for Perineal Tear
Enrolling by invitationObservational study
Study on Fewer Tears (SOFT) - The Effect of Local Anesthesia on the Incidence of Perineal Tears in the First Vaginal Birth
Perineal Laceration, Tear, or Rupture During Delivery
Recruiting
Physiotherapeutic Protocol Compared to Usual Care in the Treatment of Primiparas After Perineal Trauma
Episiotomy, Lacerations Perineal
Recruiting
Pushing Using Real-time Sonographic Ultrasound Education
Transperineal Ultrasound, Midwife-led Pushing Training Program
RecruitingObservational study
CArE for OAsI Study: Care Pathways and Anorectal Evaluation for OASI Associated Incontinence
Obstetric Anal Sphincter Injury, Severe Perineal Trauma
Not yet recruiting
The Effect of Birth Ball and Perineal Massage on Perineal Pain, Perineal Trauma and Birth Satisfaction
Perineal Pain, Birth Satisfaction
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Maisuri Chalid, Phd principal investigator
Hasanuddin University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing honey, lidocaine and povidone-iodine in people with Perineal Tear, run by Hasanuddin University at 1 site in Indonesia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Jul 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Indonesia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Correlation of the Effectiveness of Wound Healing using honey, lidocaine, povidone - iodine and control with the total REEDA ( Redness, Oedema, Ecchymosis, Discharge, Approximation) (time frame: 0 - 14 days). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Jul 2023.