Evaluation of Firooz fissure cream containing lanolin in improving the pain and severity of fissure lesions

Phase 2

Recruiting

• Conditions: N64.0; Fissure of nipple.; Fissure and fistula of nipple

• Registration Number: IRCT20190210042676N27
• Lead Sponsor: Firooz Health Group Company

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 21 November 2022

Recruitment & Eligibility

• Status: Recruiting
• Sex: Female
• Target Recruitment: 20

Inclusion Criteria

Lactating women aged 18 to 45 with term babies (weighing 2500 to 4000 grams)
General health
Signing the consent form for participation in the study
Breast pain from severity 1 to 3

Exclusion Criteria

People with puerperal fever
A newborn suffering from jaw and mouth abnormalities such as short frenulum or oral infections
Mothers suffering from diabetes
Use of any local treatment for fissure three days before the study

Study & Design

• Study Type: interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Pain during breastfeeding. Timepoint: Before intervention, 48 hours and 7 days after that. Method of measurement: By a 6-point Likert scale (Not satisfied at all = 0, Very little = 1, Little = 2, Average = 3, Much = 4 and Very much = 5).

Secondary Outcome Measures

Name	Time	Method
Severity of fissure of nipple. Timepoint: Before intervention, 48 hours and 7 days after that. Method of measurement: Severity of fissure of nipple 1 to 3 based on: 0) No microscopically visible skin changes, 1) Erythema or edema or combination of both, 2) Superficial damage with or without scab formation on <25% of the nipple surface, 3) Superficial damage with or without scab formation on >25% of the nipple surface, 4) Partial-thickness wound with or without scab formation on <25% of the nipple surface, 5) Partial-thickness wound with or without scab formation on <25% of the nipple surface.