NCT05591651

Brief Summary

Previous studies have shown that application of hyaluronic acid preparations to wounds of the skin and mucosa have a beneficial effect. There is a lack of studies showing the effect of applying hyaluronic acid preparations to treat damaged nipple skin in breastfeeding mothers. This study aims to determine the effect of applying a hyaluronic acid preparation to damaged nipple skin in breastfeeding women.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
160

participants targeted

Target at P50-P75 for phase_4

Timeline
Completed

Started Jan 2023

Typical duration for phase_4

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 13, 2022

Completed
11 days until next milestone

First Posted

Study publicly available on registry

October 24, 2022

Completed
3 months until next milestone

Study Start

First participant enrolled

January 9, 2023

Completed
2.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2025

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2026

Completed
Last Updated

July 31, 2024

Status Verified

July 1, 2024

Enrollment Period

2.9 years

First QC Date

October 13, 2022

Last Update Submit

July 30, 2024

Conditions

Cracked NippleBreastfeedingHealing Wound

Keywords

hyaluronic acidcracked nipplebreastfeeding

Outcome Measures

Primary Outcomes (2)

  • Healing of damaged nipples

    Nipple healing will be measured using the Nipple Trauma Score (NTS). Measurements will be performed by the lead researcher using the following scale: 0) no macroscopically visible skin changes; 1) erythema or edema or combination of both; 2) superficial damage with or without scab formation of less than 25% of the nipple surface; 3) superficial damage with or without scab formation of more than 25% of the nipple surface; 4) partial-thickness wound with or without scab formation of less than 25% of the nipple surface; 5) partial-thickness wound with or without scab formation of more than 25% of the nipple surface.

    30 days

  • Level of nipple pain

    Nipple pain will be estimated using an adapted VAS.The pain scale is marked by numbers 0 to 10, where 0 means no pain, and 10 is the highest pain imaginable. The mother will decide on the VAS scale, which measure best fits her pain: 0) no pain, feeling that the child is moving my breast; 1-2) minimal discomfort and pain; 3-5) moderate pain; 6-8) severe pain; 9-10) the severest pain I can imagine.

    30 days

Secondary Outcomes (3)

  • Mother's satisfaction with allocated treatment

    30 days

  • Exclusive breastfeeding rates at days 3, 7, 10, and 30 postpartum.

    30 days

  • Side effects in mother and child

    30 days

Study Arms (2)

Preparation with hyaluronic acid

EXPERIMENTAL

Treatment of damaged nipple skin: Preparation with hyaluronic acid. The hyaluronic acid preparation will contain white vaseline and 0.2% sodium hyaluronate in a 30 g container.

Drug: Treatment of damaged nipple skin: Preparation with hyaluronic acid

Neutral Preparation without hyaluronic acid

EXPERIMENTAL

Treatment of damaged nipple skin: Neutral preparation without hyaluronic acid. The neutral preparation will contain white vaseline only, in a 30 g container, and wiil have the same appearance and fragrance as the active preparation.

Drug: Treatment of damaged nipple skin: Neutral preparation without hyaluronic acid

Interventions

Treatment of damaged nipple skin: Preparation with hyaluronic acidDRUG

The active preparation will be applied for five days, locally on the damaged nipple skin after every second breastfeeding session, and at least four times in 24 hours, alternating it with breast milk.

Preparation with hyaluronic acid
Treatment of damaged nipple skin: Neutral preparation without hyaluronic acidDRUG

The neutral preparation, containing only white vaseline, will be applied for five days, locally on the damaged nipple skin after every second breastfeeding session, and at least four times in 24 hours, alternating it with breast milk.

Neutral Preparation without hyaluronic acid

Eligibility Criteria

Sexfemale
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • for mothers: a breastfeeding mother, living or residing in Osijek, with nipple skin damage (NTS 1, 2, 3, 4, or 5).
  • for babies: newborns from a singleton pregnancy, of gestational age from 37 to 42 weeks, with a birth weight of 2,500 to 4,500 grams.

You may not qualify if:

  • for mothers: mothers who do not breastfeed, mothers not living or residing in Osijek, mothers without nipple skin damage and mothers using other preparations for healing sore nipples (shells, pads).
  • for children: visible anomalies in the newborn which may affect the breastfeeding process, newborns that required admission to the neonatal unit

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Savjetovalište za dojenje, Dom zdravlja Osječko-baranjske županije

Osijek, 31000, Croatia

RECRUITING

Related Publications (4)

  • Tait P. Nipple pain in breastfeeding women: causes, treatment, and prevention strategies. J Midwifery Womens Health. 2000 May-Jun;45(3):212-5. doi: 10.1016/s1526-9523(00)00011-8.

    PMID: 10907330BACKGROUND

  • Abou-Dakn M, Fluhr JW, Gensch M, Wockel A. Positive effect of HPA lanolin versus expressed breastmilk on painful and damaged nipples during lactation. Skin Pharmacol Physiol. 2011;24(1):27-35. doi: 10.1159/000318228. Epub 2010 Aug 18.

    PMID: 20720454BACKGROUND

  • Shaharudin A, Aziz Z. Effectiveness of hyaluronic acid and its derivatives on chronic wounds: a systematic review. J Wound Care. 2016 Oct 2;25(10):585-592. doi: 10.12968/jowc.2016.25.10.585.

    PMID: 27681589BACKGROUND

  • Torretta S, Marchisio P, Rinaldi V, Carioli D, Nazzari E, Pignataro L. Endoscopic and clinical benefits of hyaluronic acid in children with chronic adenoiditis and middle ear disease. Eur Arch Otorhinolaryngol. 2017 Mar;274(3):1423-1429. doi: 10.1007/s00405-016-4327-4. Epub 2016 Oct 1.

    PMID: 27695944BACKGROUND

MeSH Terms

Conditions

Breast Feeding

Interventions

Hyaluronic Acid

Condition Hierarchy (Ancestors)

Feeding BehaviorBehavior

Intervention Hierarchy (Ancestors)

GlycosaminoglycansPolysaccharidesCarbohydrates

Study Officials

  • Maja Štimac, MD; Mr.sc.

    Specijalistička pedijatrijska ordinacija prim.mr.sc.Maja Štimac

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Maja Štimac, MD; Mr.sc.

CONTACT

+385 98 799 188maja@stimac.org

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 13, 2022

First Posted

October 24, 2022

Study Start

January 9, 2023

Primary Completion

December 1, 2025

Study Completion

February 1, 2026

Last Updated

July 31, 2024

Record last verified: 2024-07

Data Sharing

IPD Sharing
Will not share

Locations

CR(1)