Sue Huml here and I am employed part-time by Lansinoh Laboratories Inc.,

Cindy asked about the use of Hydrogels after looking at the recent study in JOGNN and while I believe there could certainly be times when a hydrogel dressing might be appropriate and work well for some women with badly abraded/damaged nipples, I feel impelled to point out that this study was NOT a study that was conducted on women with sore nipples.

Critical reading of this study shows that all the women enrolled into the study were recruited within 24 hours of birth and being a breastfeeding mother was the criteria for being recruited.

New, first time mothers, who had just begun breastfeeding were given 2 sets of hydrogels and told to 1. wash hands before nursing, 2. wash breasts before nursing 3. wash hydrogel before applying to breast. 

Women in the lanolin (Lansinoh) group were given a 7 gram tube of Lansinoh (remember they didn't even have sore nipples) - under normal use if sore nipples were present and used correctly, this sample size would only last for 3 days.  They were told to wash hands, express breast milk onto nipples, AIR DRY their nipples, then to make sure they used a breast pad to avoid staining of clothes.  Air drying the nipples would slow the healing process and deter the moist healing environment that Lansinoh creates and is important for faster healing, and they did not have enough lanolin to last more than 3 days.  Also, would any of you like to explain the clinical rationale for avoiding bra staining?

Of further note is that this study was funded by a grant from TYCO- the makers of Maternimates the hydrogel used in the trial.  

The researchers were not blinded, even though the mothers were all first time novice mothers the data was self reported via telephone. It would have been very easy to blind the researchers during the data collection period. Also, the term breastfeeding was not defined so we don't know how many were solely breastfeeding or, breastfeeding and pumping, breastfeeding and bottle feeding or what their status was.

The results were that there were no breast infections in the hydrogel group and the lanolin group had 6 cases of mastitis and 2 cases of thrush (which even though the study does not mention this the mastitis and thrush were reported after the first 12 days of the study were over and occurred between days 12-72) As we have no idea what else was going on with the mothers between days 12-72 all manner of things could happen that would cause mastitis and thrush.  In fact the study even points out that the average rate of infections is 9% and this study showed a rate of 7.55% which even included the thrush which is not really an infection. They do say that "one cannot assume a causative effect regarding the infections in the lanolin group." and, " It was also noted that there was not an increase in infections in the lanolin group"  However, these statements get lost at the end of the study.

What is really baffling is that Nancy Brent, MD, IBCLC conducted a study which was funded by the Mercy Hospital of Pittsburgh Foundation Seed Grant.  where she compared hydrogel dressings to Lansinoh.  Lansinoh had no contact with Dr Brent and only learned of this study after it was published in Arch Pediar Adolescent Med (vol 152, Nov 98)  She and her colleagues enrolled mothers who presented with sore/damaged nipples as the criteria.  The researchers were blinded, and all reporting was done by visits and infections were diagnosed by MDs, LCs or RNs.  Her conclusion was that the lanolin (Lansinoh) group should be the first line of therapy for sore nipples as this group had "the number of patients displaying a good to excellent degree of healing at follow up was significantly higher than in the dressing group" also " the Lanolin group had the larger reductions in feeding pain compared to the dressing group".  This study was discontinued early, because of the high rate of infections in the hydrogel group.

There are several other points I can make yet feel I've taken up enough space.  I am though happy to email a full detailed comment to anyone who might be interested.

Again, I will say that I am not completely opposed to the use of hydrogels for breastfeeding mothers, I know that many of you have had a good outcome with them, however, I can't let it pass that this study is out there and people are thinking this is a fair and true comparison for a treatment for sore nipples.

I am leaving on a trip in the morning and will be back Tues evening if anyone needs to get in touch with me.
Sue Huml, IBCLC, RLC, LLL     

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