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Benefits of Disposable Baby Wipes for Cleaning Diapered Skin of Pre-term

and Term Infants

Josh Gregorio, PhD, Corey Cunningham, PhD, and David Koenig, PhD, Kimberly-Clark Corp., 2015

The skin is a stretchable, rugged, sensitive, self-healing organ and perhaps our most

versatile body part. Skin maintains body temperature, retains essential fluids, and protects

the body from toxic agents, microorganisms, and harmful ultraviolet rays.1 The skin is often

taken for granted because it is so effective in performing its duties. Skin care begins with

the appropriate cleaning regimen.

Premature infant skin physiology and cleansing considerations

Premature infant skin is very delicate and lacks effective barrier protection as the stratum

corneum, the outermost layer of the skin, has not fully developed. Consequently,

premature infants have extremely high transepidermal water loss (TEWL) through their

skin and are more vulnerable to exogenous insults and stresses.2-3 Coupled with weak

resilience and structural integrity, the diapered environment can create even greater

challenges for maintaining skin health. For example, it has been extensively shown that skin

occlusion leads to over-hydration, resulting in compromised skin strength and reduced

barrier function.4 Moreover, skin irritants present in feces and urine can induce skin rash

through a variety of mechanisms including increased skin pH, proteolytic breakdown of

stratum corneum proteins and cell membrane integrity, and permeation of bile salts and

other contact irritants into the epidermis.5-6

It is also known that pre-term infants are at an increased risk of developing diaper

dermatitis as their skin barrier (stratum corneum) is not fully formed yet.7 In fact, infants

born at gestational age less than 25 weeks only have one half the thickness of both the

stratum corneum and the underlying epidermis relative to full term neonates.8-10 Thus,

premature infant skin is very permeable to both water and irritants. Additionally, infants

born at less than 28 gestational weeks lack an outer protective layer called the vernix

caseosa. Taken together, premature infants suffer from increased water evaporation from

their skin.5 It is estimated to take 2-9 weeks after birth for the skin to fully form in these

pre-term babies.5 Table 1 highlights differences in skin development between full-term and

pre-term infants and the consequences of these differences, whereas Figure 1 illustrates

key differences in skin morphology.

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Table 1: Physiological Differences in Full-term and Pre-term Skin

Skin Characteristic Full-term Pre-term Consequence

Epidermal thickness 40-50 um 20-25 um Delayed skin maturation

Stratum corneum development

Normal Poor ↑ water loss

↑ Permeability of topical agents

Cell attachment Normal Fewer ↑blistering

Dermis Normal ↓collagen

↓elastic fibers

↓elasticity ↓strength

Fat Normal Lower ↑hypothermia

Melanocytes Normal ⅓ of full-term ↑photosensitivity

Acid mantle development

Normal Delayed ↓antimicrobial defense ↑moisture loss, ↑ irritation

Adapted from Ness.11

Figure 1: Stratum corneum and epidermis are incomplete in 25 week gestational age pre-

term (left) compared to full-term neonates (right).

Why Cleaning is Important

Regularly cleaning diapered skin without causing mechanical abrasion or chemical-induced

stress is essential to maintain skin health. The concern for the latter has led many skilled

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health care practitioners and mothers alike to adopt a skin cleaning regimen consisting of a

cotton cloth/ball and water. It is the view of many that disposable baby wipes might cause

more harm than water and cotton alone, especially in infants with sensitive skin or in infants

experiencing diaper rash.12,13 This concern, although well intended, is misplaced. Many

clinical studies have evaluated the use of disposable baby wipes and compared them to

water and cloth with and without soap. The preponderance of the data developed in such

studies demonstrate the benefits of pre-moistened disposable baby wipes. Using various

methods to analyze skin health, clinical researchers have demonstrated that disposable

baby wipe use leads to lower erythema, less damage to skin barrier function as measured

by transepidermal water loss (TEWL), better maintenance of skin pH, and less irritation

when compared to the use of water and cotton or water, cotton and soap.14-16

Clinical studies have shown benefits of the use of disposable baby wipes in pre-term and

term infants from birth up to 24 months and in seriously ill neonates, as well as infants with

clinically diagnosed atopic dermatitis. For instance, a study involving 53 infants, conducted

over a 4 week period, evaluated the use of disposable baby wipes on infants with clinically

diagnosed atopic dermatitis (sensitive skin). The mean number of wipes applied to the

infants was 12 per day. Their results showed that the incidence of erythema dropped from

34% at day 1 to 14% at day 29 of the study and the investigators concluded that pre-

moistened baby wipes were suitable for everyday cleaning of sensitive diapered skin.14

Similarly, in a double blinded study involving 102 infants over a 2 week period, disposable

baby wipes were compared to water plus a cleaning material (mostly cotton wool balls) in 6

to 24 month old infants. The study found that diaper rash was significantly lower in the

skinfolds area of infants who were cleaned with disposable baby wipes compared to those

cleaned with water and cleansing materials.14 Another skin care study was conducted to

evaluate wipe use in a level III NICU and demonstrated the benefits of disposable baby

wipes vs. cloth and water towards maintaining balanced skin pH.3 This study compared

disposable baby wipes at pH ranges lower than those found in water and compared them

to water and cloth. Strikingly, the study showed that significantly less skin barrier

disruption (lower TEWL) was observed and that perineal erythema were significantly lower

in the wipe groups compared to the water and cloth groups. The authors noted that the

lower pH in the disposable baby wipes led to a lower skin pH relative to infants in the water

and cloth group, suggesting that baby wipes aided in preserving the skin’s acid mantle.3 The

importance of maintaining a low skin pH has been evaluated in many studies, highlighting

the significance for establishing the acid mantle in skin, a key defensive attribute. At birth,

the pH of skin is around 6.5 – 7, but continues to drop to around 5.5 after several days,

weeks, or months.17 The acid mantle is important in promoting skin health and function by

permitting stratum corneum maturation and preventing colonization of pathogenic

microorganisms. Premature infants are even more prone to skin colonization by pathogens

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as it takes much longer for the establishment of the skin’s acid mantle and stratum corneum

development to occur (up to 8 weeks after birth). Therefore, any diapered skin cleansing

strategy needs to take this into consideration.

The source of water used can factor greatly in the potential to harm skin, when

incorporated into a skin cleansing method. Tap water can have a pH up to 8.5, distilled

water can range from pH 6.5-7.0, and neither water source provides buffering capacity.18,19

The cleansing solutions used in the manufacture of contemporary disposable baby wipes,

although over 90% water, are typically formulated to have a final pH in the range of 4.5-6.5

and are designed to have good buffering capacity to maintain the target pH (Figure 2).

Maintaining skin pH around 5.5 helps stratum corneum development, improves barrier

function (reducing water loss), and helps protect against microbial colonization.17,20-23

Figure 2: Disposable baby wipes are formulated to complement healthy skin pH. The pH

of water can be as high as 8.5.

A recent report attributes rash development to an imbalance of skin pH following exposure

to urine and feces.24 This mixture leads to activation of digestive enzymes present in feces

that can damage the stratum corneum through degradation of lipids and proteins in the

skin.2,24 Infant feces contains lipolytic and hydrophobic enzymes that are immiscible in

water. Cleansing practices that only include water may not adequately remove these

materials and can result in stratum corneum damage and rash development. Effective

removal of lipid soluble lipolytic enzymes requires surfactants or detergents to emulsify

and trap them into surfactant micelles (droplets).25 It has been shown that mild surfactants

can be effectively used to remove these harmful substances without compromising skin

health. Thus, many contemporary disposable baby wipes contain low concentrations of

mild surfactants to accomplish this task while affording skin benefits that water and cloth

alone cannot provide.

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Considerations for Cleansing Diapered Skin

Cleaning the skin is the major benefit of personal care wipe products like disposable baby

wipes. In the case of perineal skin, microorganisms and other fecal-derived soils present

unique challenges. Furthermore, infant stool contains a variety of secretions that can be

found on diapered skin (Table 2).

The major soil on infant skin during diaper use is feces. The normal daily stool of human is

about 250 g. Normal feces are roughly 75% water and 25% solids.26 The bulk of fecal solids

are bacteria and undigested organic matter and fiber. More than 75 different kinds of

bacteria are found in feces.27 Other constituents are digestive secretions, enzymes, fats,

cell debris, electrolytes, water, and small amounts of protein.26 The characteristic brown

color of feces is due to stercobilin and urobinin, both of which are produced by bacterial

degradation of bilirubin. Fecal odor results from gases produced by bacterial metabolism,

including skatole, mercaptans, and hydrogen sulfide.26 Microorganisms, which constitute a

large portion of fecal dry weight, attach to the skin by multiple mechanisms, requiring a

complex removal strategy employing surfactant action, shear forces, and affinity binding.

The understanding of these interactions, and the role they play in the tightness of binding

of the soil to skin, is imperative in the development of safe, gentle, yet effective cleaning

technologies for inclusion into disposable baby wipes.

Table 2: Soils and Soil Components Relevant to Diapered Skin

Secretion Description Source

Mucus Composed of secretions from the mucopolysaccharide rich glands, inorganic salts, desquamated cells, and leucocytes

Oral, Nasal, Uro-Genital, GI

Bile Derived from cholesterol in liver, modified by bacteria in intestine. Important for digestion and absorption of fat

GI

Gastric juices Secreted by stomach mucosa. Consists of HCl, pepsinogen, intrinsic factor, gastrin, mucus, and bicarbonate buffers

GI

Pancreatic juice Consists of insulin, glucagon, pancreatic enzymes (trypsin and chymotrypsin) for digestion of fats and proteins in small intestine.

GI

Feces Consists of bacteria, cells exfoliated from the intestines, non-degraded digestive enzymes, and a small amount of food residue.

GI

Urine Aqueous solution of urea, salt, and uric acid, with some hippuric acid and pigments.

Usually ~96% water to ~4% solid matter

GI

Smegma Sebaceous matter that collects between the glans penis and the foreskin

GI

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Not surprisingly, an infant’s diet can have an impact on fecal composition. While infant stool

solids are primarily composed of bacteria and mucin, calcium and fatty acid soaps are also

present. Stools from formula-fed infants have higher solids content and contain higher

levels of minerals and lipids and considerably less carbohydrates than breast feed infants.

Differences in fecal lipids derived from formula- and breast-fed infant stools are due almost

entirely to fatty acids (mainly C16:0 and C18:0) excreted as soaps.28 Fatty acid soaps,

predominantly saturated, accounted for one third of the stool dry weight of breast fed

infant stools. Additionally, there is a significant difference in the microbiota of stools

collected from breast fed and formula fed infants (Table 3).29,30

Table 3: Predominant Microbes in Infant Feces

Breast Fed Milk Fed / Solid Food

Bifidobacteria (90%) Bifidobacteria

Enterobacteriaceae

Enterococci (~9%)

Lactobacilli

Bacteroides, Staphlococci, Lactobacilli, Clostridia (~1%)

Clostridia, Bacteroides, Enterococci

To remove all these soils from the skin an efficient cleaning process is required. Cleaning

of skin can be divided into three processes. The first is a traditional wash, or bath, wherein

the soil is removed primarily with a solution containing a surfactant. The second is a dry

wipe, such as a bath tissue our hand towel, in which soil is removed through the physical

process of wiping the skin. The third process is the combination of a solution and wipe in

what is commonly marketed as a wet wipe. Disposable baby wipes provide convenient

cleaning advantages by combining the action of both a surfactant solution and the wiping

action of a towel or tissue.

Most solution-based skin cleansing products remove soils primarily through surfactant or

detergency action. This cleaning action uses physicochemical processes leading to the

removal of soil from the surface of the skin. Cleansing action results from the presence of

surface-active agents (surfactants), which are capable of forming an adsorption solvation

layer around the dispersed-phase particles (soil) and on the cleansed surface.31 The high

surface activity of such compounds is required for efficient dispersion and removal of soil

from the skin.

The initial stage of solution based cleansing is the wetting of the soiled surface by lowering

surface tension. The emulsification of liquid soils is usually accompanied by their

dissolution into micelles of the cleansing agent. The introduction of various inactive

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additives (salts and water-soluble polymers) increases the cleansing action of soaps and

especially of synthetic detergents. The combined use of various types of surface-active

agents in detergents usually increases the efficiency of the cleansing agents. As some

surfactants can be irritating to the skin, extreme care must be taken when developing a

cleansing solution.32

In contrast, a dry application, such as bath tissue, cleans soil from the skin as a result of

shear force, affinity, or a combination of the two. Friction is defined as the force that resists

relative motion between two bodies in contact.33 This motion produces stresses and

strains on both the bath tissue and soil on the skin, thereby releasing the soil from the skin

once the energy thresholds are overcome. Stress is the force exerted when one body

presses on, pulls on, pushes against, or tends to compress or twist another body, as can be

seen in the motion of bath tissue across skin.34 Strain is the deformation of a material body

(cleansing wipe) under the action of an applied force.33 Friction is thought to cause the most

damage to the skin during the cleaning process.35 Dry wiping of the skin can leave a

significant amount of fecal material behind on the skin as well as cause skin damage. The

inclusion of water can greatly increase the cleaning performance and reduce skin damage.

The mechanism of action for a baby wipe is a hybrid of solution-based and dry wipe cleaning

processes. For the soil to be removed from the skin the adhesion forces between the soil

and skin must be overcome. These adhesion forces are a combination of van der Waals,

electrostatic, and capillary forces.

When a baby wipe is used, a number of release forces are available for the cleaning process

that are not available to a solution or dry wipe alone. These forces include drag, net

buoyancy, and capillary forces (Figure 3). As a wet wipe is moved across the skin, a liquid

front is pushed in front of the wipe, creating a shear drag force that is parallel to the wiping

motion that helps release the soil. The net buoyancy force depends on the relative densities

of the liquid and the soil. In most cases, the relative density of the particle is reduced due to

the presence of water. Wet wipes also provide a capillary force that aid in removal of feces

from the skin. Specifically, disposable baby wipes may alter existing capillary forces

between skin and feces or may reduce surface tension between feces and skin to decrease

adhesion. The addition of surfactants to the wet wipe solution provides a way to counteract

both adhesion forces and associated capillary forces that bind many soils to the skin.36

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Figure 3: Wiping interactions on skin

Disposable baby wipes are a common method used for cleaning diapered skin. A baby wipe

provides a wetting solution that reduces both the electrostatic forces of adhesion of the

soil to skin as well as decreasing the capillary forces. Additionally, the force of the material

against the skin provides a shear stress to aid in removal. The baby wipe then can trap the

soil removing it once it is released from the skin. Once trapped on the wipe, the soil is less

likely to be re-deposited. Wiping the skin with a fresh wipe surface also acts like a rinsing

step to ensure no residual soil remains on the skin. Critical to the whole process is the level

of wetness of the wipe. The optimum range is defined by the wipe substrate type, solution

wetting the wipe, and the application. A baby wipe that is too dry or too wet will not trap

soil well. The dry baby wipe just pushes the soil around on the skin while the overly moist

baby wipe will entrain the soil contaminants in the solution allowing for re-deposition onto

the skin. Most commercial baby wipes have tightly controlled wetness levels to maximize

the cleaning and trapping process.

The Evolution of Wiping Substrates

Baby wipes were first introduced in the 1990’s and the major share of the disposable baby

wipe market was occupied by Kimberly-Clark’s HUGGIES® and Procter & Gamble’s

Pampers® brands. This is still true today, despite the gains in the market by smaller, private

label manufacturers. Regardless of the company selling it, the wipe consists of three main

components – substrate, formulation, and package. All of these components have changed

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dramatically over the years resulting in a more functional and aesthetically pleasing

product.

The first baby wipe products consisted of substrates made from carded rayon fibers held

together with adhesive binders. These wipes were strong and thin, but had a rough surface.

In the mid-1990’s, the introduction of air-laid nonwovens dramatically changed the wipe.

Constructed of wood pulp, polyester and adhesive binders, these air-laid wipes were much

softer and thicker. Coform, which combines meltblown polypropylene fibers and pulp to

produce a highly absorbent material with outstanding wet integrity was developed in the

late 1990’s by Kimberly-Clark as a competitive technology to the initial adhesive bonded

air-laid.

The mid 1990’s saw further modification to air-laid nonwovens as companies altered fiber

composition and fiber to polymer blend to optimize performance. Bi-component fibers,

which were also developed in the 1990’s and combining two polymers into each fiber, once

again improved the attributes of air-laid producing substrates with increased strength,

softness, and thickness. Despite these innovations, coform is considered to be a premium

product and continues to evolve.

In the 1990’s, two new substrate forming technologies, thermal bonding and hydro-

entanglement, were developed and have been utilized. The first, thermal bonded, used heat

to hold the wood pulp and polypropylene together. One common variant made by this

process is spunbond. Spunbond is a strong, flexible material manufactured with continuous

fibers that are thermally bonded to create a fabric. Hydroentangled, also known as

spunlaced or water weaving, entwines individual fibers with high pressure jets of water.

Both of these new processes were advantageous as they eliminated the use of adhesives

and allowed for wider fiber choices. Today, premium wipe products may utilize any one of

these processes to offer the delivery of very soft, low abrasion, cloth-like wipes to the baby

care market.

Disposable Baby Wipes that Address Pre-term Infant Skin Cleansing Needs: Wipe Formulation Considerations

Formulating cleansing wipes for infants is difficult as there are many factors to consider in

the development process.38 The ideal baby wipe contains: 1) a large percentage of water; 2)

an extremely mild surfactant system that lowers surface tension to wet-out soils while not

irritating skin or removing skin lipids; 3) ingredients that enhance glide across the skin to

minimize frictional damage during the wiping process,39 4) finally, a preservation system

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that ensures product freshness while not irritating the skin. Optional emollient ingredients

could be present that help replenish lipid components in the skin through deposition.

For the general population, surfactant systems typically utilized in name brand and private

label wipes are well tolerated. The amount of surfactant is typically less than 1% and most

companies use amphoteric surfactants such as Coco-Betaine, Cocamidopropyl Betaine and

Sodium Cocoamphoacetate. Amphoteric surfactants contain both a positive and negative

charge on the molecule. These surfactants are an ideal choice for baby wipes as they are

much less irritating than typical anionic and cationic surfactants found in many shampoos,

hand & body washes and antibacterial hand soaps.

For individuals with under-developed or damaged skin barrier, such as premature infants,

the use of wipes with non-ionic surfactants reduce the irritation potential relative to other

surfactants. Such non-ionic surfactants would include Polysorbate 20, Glyceryl Stearate

and Bis-PEG/PPG-16/16 PEG/PPG-16/16 Dimethicone.

To enhance the glide of the wipe across the skin (i.e. reduce the friction), well known body

lotion ingredients like Dimethicone are advantageous. Other, less common skin emollients

such as Ethylhexyl Stearate and Cetearyl Isonononate can enhance glide as well. These

long chain fatty esters form a thin layer between the wipe and skin and reduce friction.

Probably the most important aspect of a baby wipe is the preservative system. While the

popular media often seems to suggest that all preservatives are ‘bad’ and do more harm

than good, the exact opposite is true. If preservatives were not present in the formulation,

there would be a high risk of microbial contamination of the product before or after first

use. Beyond aesthetic considerations for the product such as off-color, odor, and poor

tactile aesthetics, such contamination could lead to serious infections.

While there are preservatives that can cause sensitization (i.e. Methylisothiazolinone),

these have been removed from all branded wipes within the last two years and can only be

found in a few private label and hospital brand wipes. Other preservatives with

questionable safety profiles, such as formaldehyde donors (i.e. DMDM Hydantoin, Sodium

Hydroxymethylglycinate) have been absent from almost all wipe products for the last five

years. Virtually every preservative system has some potential to illicit an irritation

response in some sub-population. The goal of every product is to reduce this probability.

Preservative and preservative-enhancing ingredients that are very well tolerated include

Sodium Benzoate/Benzoic Acid, Potassium Sorbate/Sorbic Acid, Caprylyl Glycol and

Disodium EDTA.

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In addition to the required aspects of every baby wipe, there exists the opportunity to

include specialty ingredients for specific wipe applications that provide specific skin health

benefits. For example, emollients can be included to enhance skin barrier function.

Humectants (water-loving moisturizers) like Glycerin can help to improve the water

retention of the skin to afford moisturization benefits. Oil soluble emollients like Behenyl

Alcohol, Stearyl Alcohol, Stearic Acid and triglycerides help the skin barrier by depositing

lipid-like substances that may get stripped away during bathing. Importantly, Behenyl and

Stearyl alcohols, unlike Ethanol and Isopropanol, do not irritate the skin or elicit “stinging”

sensations.

In conclusion, despite the under-developed and compromised skin conditions experienced

by pre-term infants, baby wipes effectively remove harmful soils (see Table 2) while

maintaining skin health. Numerous clinical studies in pre-term infants have demonstrated

that formulated baby wipes are both well tolerated and promote acid mantle development

of the skin. The deleterious consequences of prolonged fecal and urine insults on skin

health have been well documented. Formulated baby wipes, as opposed to the use of water

and cloth, or water and cotton wool, can provide additional benefits to effectively remove

soils from diapered skin. Importantly, feces contains both hydrophobic (water fearing) and

hydrophilic (water loving) compounds. Effective cleansing regimens must be able to

effectively remove both. Formulated baby wipes, designed with this premise in mind,

effectively remove hydrophobic and hydrophilic materials whereas the use of water and

cloth, or water and cotton wool, cannot afford the benefits conferred by baby wipes (Figure

4). Thus, cleansing regimens based on water and cotton cloth/wool can leave potentially

harmful irritants on the skin that can lead to skin breakdown and rash.

Figure 4: Disposable baby wipes contain surfactants that can effectively remove both

hydrophobic and hydrophilic fecal material unlike water and cloth. In addition, studies

conducted in pre-term and term infants have demonstrated that the use of disposable baby

wipes leads to reduced skin redness and irritation, decrease water loss, and balanced skin

pH relative to the use of water and cotton/cloth.

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