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90 Pol Ann Med. 2019;26(2):90–97
Research paper
Maryam Hajikarimi1,2 , Soheila Mojdeh 2, Mohsen Shariari 2
1 Student Research Center, School of Nursing and Midwifery, Isfahan University of Medical Sciences, Isfahan, Iran
2 Ulcer Repair Research Center, School of Nursing and Midwifery, Isfahan University of Medical Sciences, Isfahan, Iran
Corresponding author: Maryam Hajikarimi, Nursing and Midwifery Care Research Center, Faculty of Nursing and Midwifery,
Isfahan University of Medical Sciences, Isfahan, Iran.
E-mail address: maryamhajikarimi97@gmail.com.
Comparison of a novel herbal skin care ointment with regular oint-
ments to treat skin around the abdominal stoma: A clinical trial study
Article info
Article history
Received 3 June 2019
Accepted 31 July 2019
Available online 12 December 2019
Keywords
Stoma
Patient
Skin care
Herbal ointment
Doi
https://doi.org/10.29089/2019.19.00086
User license
This work is licensed under a
Creative Commons Attribution –
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4.0 International License.
AbstrAct
I n t r o d u c t i o n : The incidence of gastric ulcers in patients with abdominal sto-The incidence of gastric ulcers in patients with abdominal sto-
ma is high and affects the quality of patients’ life.
Aim: To evaluate the effect of Adib herbal ointment containing chamomile
rose, black nightshade origin versus Comfeel and Conveen ointments on the skin
of abdominal stoma.
Material and methods: This is a clinical study in which the volunteers
were stoma patients. Study group consisted of 52 qualied subjects, 26 were inc-
luded in the experimental group and 26 in the control group. A 2-part question-
naire was used for the data collection. The 1st part was demographic information.
The 2nd part of the data collection was evaluated according to the pressure ulcer
scale for healing (PUSH) tool, which used for examining skin ulcers around the
stoma. P ≤ 0.05 was considered as a signicant.
Results and discussion: The results of the Mann–Whitney test showed
that between the mean score of the total score of the wound before intervention
(P = 0.92) and on the 3rd day (P = 0.476), 6th (P = 0.222), 9th (P = 0.11) and
12th (P = 0.418), there was no signicant difference between the control and test
groups. Also, the Friedman test (intra-group) also showed that between the mean
score of the total score of the wound before the intervention and the 3rd, 6th, 9th
and 12th days in the control group (P = 0.0001) and in the experimental group
(P = 0.0001) There was a signicant statistical difference.
C o n c l u s i o n s : Based on the study, Adib herbal ointment could be recommen-Based on the study, Adib herbal ointment could be recommen-
ded for the treatment of stoma to the skin as an herbal product as other common
treatments.
Journal homepage: hps://www.paom.pl
Polish Annals of Medicine
91 Pol Ann Med. 2019;26(2):90–97
1. INTRODUCTION
The skin is the largest and one of the most active organs in
the body, covering an area of 2 m2.1–3 A discontinuity in the
body membrane that blocks the membrane as part of its or-
gan to continue its normal function is called an ulcer. In fact,
it is well known that ulcers are the loss of epithelial cells that
have spread to the skin, and several factors are involved in the
formation process, such as mechanical, chemical, etc.4 The
patient’s excretory secretions, such as in ostomy patients, can
destroy the skin’s defense barrier and produce several degrees
of ulcers, such as dermatitis and even severe scarring.3 Colos-
tomy is an invasive surgery that is performed on the lower
gastrointestinal system for a variety of reasons.5 There are
more than 1 000 000 people in the United States and 102 000
in the United Kingdom. According to the Iranian Ostomy
Association, the number of stoma in Iran is about 30 000, in-
cluding 70% colostomy, 20% ileostomy and 10% urostomy.6,7
Patients with stoma are prone to osmotic necrosis, post-
stroke, prolapse, stenosis or obstruction and skin irritation.5
Despite extensive advances in the treatment and manage-
ment of stoma in recent years, the prevalence of skin damage
around the ostomy is a constant case.8,9 The care of the skin
around the stoma is a growing concern and can be expanded
rapidly, the skin surrounding the stoma inammation can
make sticking the ostomy bag difcult, which itself causes
damage to the skin. Hence, one of the important nursing
interventions in these patients is skin care and maintaining
skin integrity. Skin care is one of the tasks of nurses and
nurses as a key member of the treatment can offer new so-
lutions in the treatment of this disorder.10 Today, advanced
dressings are easy to use on the patient’s body and are easy
to remove and make the patient feel good.
Scientists are seeking to produce products that are easy
to install, use, and remove. These products are very sensi-
tive and should to have low odor.11 According to the latest
researches on the prevention and treatment of ulcers, various
methods of protecting strips, glycogen dressings, pectin and
gelatin base skin barriers, glycerin hydrogel skin dressings,
hydrocolloid powders, chamomile ower extract, and Senegal
acacia ower extract are used.12 In addition, according to the
experience and observations of the researchers, Comfeel and
Conveen commercial ointments are now used to treat these
ulcers in the research eld. It is worth noting that these oint-
ments are more expensive than low yields, so providing suit-
able alternatives at a lower cost, taking into account the ef-
fectiveness and cost of domestic production is a priority. In
recent years, nurses have conducted extensive research on
adjuvant therapies that nurses can use, including tactile ther-
apy, herbal therapy, art therapy, and relaxation techniques.13
In many countries, the use of herbs, herbal extracts and
other herbal products (such as Acacia senegal, Aloe vera, Euca-
lyptus, tea, etc.) has a long history and is used to treat ulcers or
burns.14–19 Chamomile is one of the herbs considered in tradi-
tional medicine due to its various characteristics. Its main in-
gredients include alfa-bisabolol, bisabolol oxide, Spiro-water,
chamazolin and avonoids. Bisabolol can effectively reduce in-
ammation and wound healing, and also has pain relief effects.
Flavonoids also have anti-inammatory and sedative effects.
Chamomile is used for skin inammation, allergic dermatitis,
and itchy skin, caused by scratches and surface cuts, and no ob-
vious adverse reactions. Various clinical studies have evaluated
the effectiveness of chamomile in wound healing.20,21
Adib herbal ointment with chamomile rose, black night-
shade origin, produced by Adib Eksir Company (Teheran,
Iran) is licensed by the Iran Ministry of Health and its in-
gredients play an important role in wound healing. Adib
herbal ointment is a newly produced herbal ointment. It
contains the active ingredients of multiple plants includ-
ing nigrum and rose extracts, ascorbic acid, wax, oleic acid
(37%–49%) and linoleic acid (37%–47%) (Table 1). Various
researches about the herbs used in ointment indicated dif-
ferent properties such as antibacterial properties, for the
prevention of ulcerative infection, anti-scar effect, and in-
Table 1. Comparison of different types of ointments.
Types of ointment Main Ingredients
Adib herbal ointment
Multiple plants including Nigrum and Rose extracts
Ascorbic acid
Wax
Oleic acid (37%–49%)
Linoleic acid (37%–47%)
Comfeel ointment ingredients
Cera Microcristillina
Glyceryl Oleate
Lanolin Alcohol
Cyclomethicone
Magnesium Citrate
Methylparaben
Propylparaben
Conveen ointment ingredients
Zinc Oxide 12%
Dimethicone 1%
Lanolin Oil
Tocopheryl Acetate (Natural Vitamin E)
Cetyl Alcohol
Glyceryl Stearate
92 Pol Ann Med. 2019;26(2):90–97
creased repair speed, anti-inammatory properties without
anti-inammatory adverse effects and without immunosup-
pression, reducing 80%–90% of the cost of treatment by not
having to admit to the hospital. Burn ointments are offered
at different and high prices all over the world, while they
do not have the desired effect, while the cost of the Adib
herbal burn ointment is much lower than that of existing
products.22 Since in most parts of Iran different types of
plants are cultivated and their pharmaceutical processing is
possible, in the case of identication of their effects accu-
rately, they can be used in the treatment of various diseases.
If the therapeutic effects of the herbs are determined, the
use of these plants is far better than chemical drugs because
chemical drugs have a lot of harmful effects.23
There are only a few studies in this eld. In this regard,
this ointment is a natural, inexpensive and affordable oint-
ment, and despite the scientic advances, there is still no
denitive treatment for the healing of these ulcers. Consid-
ering the fact that this complication has a high prevalence in
patients with ostomy and affects the quality of life of these
patients, the adoption of an appropriate approach in treat-
ment of this disorder can play a signicant role in accelerat-
ing its recovery.
2. AIM
The aim of this study is to evaluate the effect of Adib herbal
ointment containing chamomile rose, black nightshade ori-
gin versus Comfeel and Conveen ointments on the skin of
abdominal stoma. The aim of this study was also to compare
the effect of Adib, Comfeel and Convene ointments on the
skin surrounding the abdominal stoma. The results of this
study could provide a new and suitable method for the re-
covery and prevention of these ulcers.
3. MATERIAL AND METHODS
3.1. Study design
This is a clinical trial study conducted at the Alzahra Hos-
pital afliated to the Medical University of Isfahan, Iran,
in 2016. In this study, samples were randomly assigned to
the experiment (Adib ointment care) and the control group
(Comfeel and Conveen ointment care).
3.2. Standard criteria
Inclusion criteria were abdominal stoma, skin irritation
around the colostomy, chemotherapy or radiation during the
study, non-use of corticosteroids, no active skin diseases (al-
lergic diseases, psoriasis, candidiasis and skin allergies), no
diabetes, and no weight loss below 2 kg, colostomy without
prolapse or retraction and receiving a 3–10 score through
the pressure ulcer scale for healing (PUSH). Exclusion cri-
teria were patients treated with chemotherapy, radiotherapy,
corticosteroids and patient death during the study.
3.3. Data collection
In order to collect data, a questionnaire and a tool (PUSH)
for the examination of stoma wounds were used. The ques-
tionnaire consisted of demographic information and patient’s
information, including height, weight, history of the disease,
medications, time of colostomy, and potential complications.
The data acquisition tool included a PUSH tool for examining
skin ulcers around the stoma. The PUSH tool is a commonly
used tool developed by the National Pressure Ulcer Advisory
Panel (NPUAP), which grades pressure ulcers based on size
of wound, wound bed tissue type, and exudate amount.
The PUSH tool, used to assess the wounds, 3 parame-
ters applied to evaluate the wound healing process and the
intervention results. The 1st parameter is the wound area,
which is measured in terms of the longest length and the
largest width in square centimeters. The wound area is 0–10
points depending on the area. The 2nd parameter refers to
the amount of exudate present on the wound after removal
of the dressing and before application of a topical agent. The
3rd parameter is the appearance of the wound bed, which is
dened as the type of tissue present in the region.
The sum of these parameters is scored as a total score of
0–17. A higher value indicates that the ulcer is more severe,
and a lower value indicates a better healing. Therefore, the
PUSH tool generates PUSH scores using only three varia-
bles that describe the ulcer state and healing progression.24,25
3.4. Ethical consideration
After receiving the permission of the university ethics commit-
tee, the subjects were selected who had the criteria for entering
the research, and by clarifying the purpose of the study as well
as the advantages and disadvantages of the individual methods,
the written documents were supplemented by the approval
subjects, demographic questionnaire and a special question-
naire on disease information such as place of colostomy, time of
colostomy, occurrence of a skin problem around the colostomy.
3.5. Intervention procedure
Eligible study subjects were randomly assigned to both
groups using a randomized table. Each random subject was
randomly assigned an odd or even number, so sampling con-
tinues until the number of subjects is completed. Of the 52
eligible individuals, 26 were in the experimental group and
26 were in the control group.26–35 Both groups of skin ulcers
were tested and controlled by the PUSH as a special tool for
assessing the skin around the stoma. According to the tool’s
guide, the ulcers get scores 3–10. In the routine care, after
washing the skin around the colostomy with baby shampoo
and normal saline, the skin was gently dried with gauze and
then immersed with Comfeel and Conveen ointments. The
ointment remained on the skin for 20 minutes, and since the
presence of ointment and any fatty substances on the skin
interfered with the sticking of the bag, after 20 minutes, the
ointment should be washed off the skin and after the drying,
a colostomy bag was glued. It is noteworthy that people with
ostomy in the area surrounding the stoma suffer from skin
ulcers exactly at the adhesive site of the ostomy bag, so their
93 Pol Ann Med. 2019;26(2):90–97
skin care was done at the time of the exchange of the bag. Af-
ter the rst intervention on days 3 and 6, the wounds in the
test group were again disturbed by the PUSH tool.
On the 6th day, the intervention was interrupted, but
in the event of a wound, the patient was required to go to
the 9th day. Care in the control group was in the following
way: during the 1st visit, the ulcers were assessed by the
tools, ranked and the routine care was done. In the routine
care, after washing the skin around the colostomy with baby
shampoo and normal saline, the skin was gently dried with
gauze and then immersed with Comfeel and Conveen oint-
ments.
After 20 minutes, Comfeel and Conveen ointments were
washed off the skin. The patient’s ulcer was re-examined
in the control group on the 9th day after the rst visit. The
ulcer of the test group was intervened to complete recovery
according to the criteria determined by the physician of the
health center and ultimately the time it took to recover the
ulcer was calculated. It should be noted that the interven-
tion was performed by the researcher in the female patients.
In order to observe the ethical issues, the intervention in the
male patients was carried out by a fellow male nurse who
had been trained, using a completely similar and stand-
ard method. Sampling in the morning shift was performed
throughout the week from 8:00 am to 2:00 pm on the 15th
day after assuring of the ulcer recovery.
3.6. Statistical method
After collecting the required data, the results were analyzed
using SPSS v. 22 software and then studied by descriptive
and inferential statistics.36–41 The Kolmogorov–Smirnov test
was used to assess the normality of the data.42–46 All subjects
in the two groups were classied and analyzed by statistical
tests of the χ2, Mann–Whitney and Fridman tests.47–52 In the
present study, a P ≤ 0.05 was considered to be signicant.
4. RESULTS
The mean age of the subjects was 57 years and the age ranged
from 46 to 72 years; 81% of the participants were illiterate.
The duration of colostomy is from 6 months to 5 years with
an average of 2.2 years. Most subjects (86%) underwent co-
lostomy for more than a year. All patients used two-piece
bags. The score of condition of the ulcer around the colos-
tomy of 8 subjects (15.38%) was 7, 13 (25%) was 6, 12 (23%)
was 5, 12 (23%) was 4 and 7 (13.46%) was 3 (Table 2).
Subjects of the experimental and control groups in terms
of quantitative variables (age, body mass index, duration of
colostomy, number of weekly baths, average rating of ulcer
score, mean rank of ulcer color change scores, rank of re-
covery days) with independent T-test and Mann–Whitney
test and in terms of homogeneous qualitative variables (sex,
education level, frequency distribution of patients based on
total score of ulcer) with χ2 test were homogenous and a sig-
nicant difference (P > 0.05) between the above variables
was not found. Comparison of the frequency distribution of
patients based on the total score of the ulcer in the test and
control group before intervention is shown in Table 3.
Comparative results of the mean total number of ulcers
before the intervention, 3rd, 6th, 9th and 12th days in the
control and test groups are shown in Table 4. The total score
Table 2. Frequency distribution of ulcer score based on the duration (day) of recovery in the experimental and control group.
Experimental group Control group
Ulcer score 3 4 5 6 7 Total 3 4 5 6 7 Total
Study day
3 3(11.53) 1(3.84) 0(0) 0 (0) 0 (0) 4(15.38) 1(3.84) 2(7.69) 1(3.84) 0(0) 0(0) 4(15.38)
6 1(3.84) 3(11.53) 3(11.53) 0(0) 0(0) 7(26.92) 2(7.69) 1(3.84) 1(3.84) 1(3.84) 0(0) 5(19.23)
9 0(0) 1(3.84) 4(15.38) 4(15.38) 2(7.69) 11(34.61) 0(0) 3(11.53) 2(7.69) 4(38/15) 2(7.69) 11(42.3)
< 12 0(0) 0(0) 0(0) 2(7.69) 2(7.69) 4(15.38) 0(0) 1(3.84) 1(3.84) 2(7.69) 2(7.69) 6(23.07)
Total 4(15.38) 5(19.23) 7(26.92) 6(23.07) 4(15.38) 26(100) 3(11.53) 7(26.92) 5(19.23) 7(26.92) 4(15.38) 26(100)
Comments: Experimental group – Adib herbal ointment; Control group – Comfeel and Conveen ointments. All numbers are given as n(%).
Table 3. Comparison of frequency distribution of patients based on the total score of ulcer in the experimental and control
groups before intervention.
Score of ulcer around the colostomy Experimental group Control group Statistical test
N(%) Mean SD N(%) Mean SD Pχ2
3 4(15.38)
5.03 1.31
3(11.53)
3.08 1.29 0.92 –0.9
4 5(19.23) 7(26.92)
5 7(26.92) 5(19.23)
6 6(23.00) 7(26.92)
7 4(15.38) 4(15.38)
Total 26(100.00) 26(100.00)
Comments: P ≤ 0.05 was considered as a signicant.
94 Pol Ann Med. 2019;26(2):90–97
of the wound before the procedure (P = 0.92) and on the 3rd
(P = 0.476), 6th (P = 0.222), 9th (P = 0.11) and 12th (P=
418) days showed no signicant difference between the con-
trol and test groups. The Friedman test (Intra group) also
showed that between the mean score of the total wound site
before the procedure and the 3rd, 6th, 9th and 12th day in the
control group (P = 0.0001) and in the experimental group
(P= 0.0001) there was a signicant statistical difference.
5. DISCUSSION
The results of this study showed complete healing in the skin
around colostomy in all patients on the 15th day of the two
groups of experiments (Adib ointment) and the control group
(Comfeel or Conveen ointment). In the current study to bet-
ter evaluate our experiments, we used two control groups. In
the present study, there was no signicant difference in ulcer
healing of colostomy between the experimental group and
the control group on any day (pre-intervention, 3rd, 6th, 9th,
and 12th days). In other words, Comfeel, Conveen or Adib
ointment has a similar effect on the healing process of ulcers.
Although all patients with scores of 3, 4, and 5 in the experi-
mental group recovered completely on the 12th day, 2 of the
4 and 5 patients in the control group did not fully recover on
the 12th day, which was not statistically signicant. In gen-
eral, it can be said that chamomile is superior to Comfeel or
Conveen in the treatment of low-scoring ulcers.
In the study of Ala et al.60 adults had secondary burns, and
the burned area of the body and trunk was 1%–10%. The av-
erage recovery time of the Adib skin ointment group and the
sulfadiazine ointment was 7.5 and 11.8 days, respectively (P
< 0.0001). The mean treatment satisfaction rates for the Adib
derm and sulfadiazine groups were 7.5 and 7.8 days, respec-
tively (P < 0.041). In the sulfadiazine cream group, 1 (3.3%)
patients had wound infection, and 7 (23.3%) of the Adib skin
ointment group had ulcers due to ointment. In this study, most
patients did not receive this treatment due to lack of knowl-
edge or lack of information about herbal Adib’s ointment; this
limitation is consistent with the limitations of this study.
In another study, the treatment of lesions around the
stoma caused by chamomile was better than treatment with
1% hydrocortisone ointment. The previously reported results
used German chamomile to treat atopic dermatitis, skin car-
tilage area. Skin disease, pressure ulcers, mouth ulcers, plaque
and gum inammation are consistent with it. The problem of
patients using chamomile was reduced by 50%, and the num-
ber of patients using 1% hydrocortisone was reduced by 41%.
Hydrocortisone in the chamomile solution group uses their
ointment daily for 2 times a day. Most of the lesions in these
patients (69%) were similar to this study and were classied
as acute dermatitis. The response in both treatment groups
was good at the beginning of the treatment, but contrary to
the study, the chamomile treatment group responded signi-
cantly faster than the corticosteroid group.53
Ferreira et al. was shown that the standardized extract of
chamomile signicantly reduced wound secretion in 14 pa-
tients after tattoo removal. In this study, lesions treated with
the German chamomile solution also showed a signicant de-
crease in exudate levels. The mean recovery time in the study
was approximately the same as the results of this study. The
total treatment time in the chamomile group was 8.89 ± 4.89
days and in the hydrocortisone group 14.53 ± 7.16 days. This
study also showed that that the use of chamomile gel before
radiotherapy was helpful in preventing radiation dermati-
tis.54 However, in the study by Pazandeh et al. was shown that
chamomile essential oil had no effect on the treatment of gen-
ital incision. There was no signicant difference in the mean
scores of vulvar incision treatment between the two groups
on the 17th and 14th day after delivery.55 In general, improv-
ing and maintaining the integrity of the skin stoma is very
important for ostomy patients and ostomy care professionals.
The integrity of the sebaceous glands plays a crucial role in
improving the quality of life of patients with stoma.56 About
60%–67% of patients with stoma develop pristomal complica-
tions.57 Pristal skin problems are the most common compli-
cations after stoma surgery.58 Failure to consider these issues
will result in delayed patient recovery, decreased patient qual-
ity of life, and increased health care costs.57 In another study,
the most serious skin pain complications were fecal leakage
due to weakened skin structure and skin-induced dermatitis,
and similar results were found in a survey of 89 nurses. In the
above study, nurses reported that the most common compli-
cation was skin ulcers (55% response rate) due to leaks in the
ostomy device (61%) and accessories (44%), which are easily
repaired.59 These cases are also consistent with the present
study. In a study by Ratcliff in collaboration with 12 nurses,
89 patients with colostomy examined the ileal channel over a
Table 4. Comparison of the mean score of the total ulcer score at pre-intervention, 3, 6, 9 and 12 days between the two groups
of control and experimental.
Variable Experimental group Control group Mann-Whitney statistical test
P
Day Mean rank Mean rank
Pre-intervention 4.60 4.83 0.925
3 3.96 3.85 0.476
6 2.92 2.65 0.222
9 2.00 1.98 0.11
12 1.52 1.69 0.418
Friedman statistical test P0.001 0.001
Comments: P ≤ 0.05 was considered as a signicant.
95 Pol Ann Med. 2019;26(2):90–97
period of 12 months. In 42%–47% of patients, several physical
complications occurred during this period, including chronic
dermatitis, mechanical damage, Candida infection, allergic
reactions and pyoderma gangrenosume. In another study
of this researcher, it was found in 220 patients with stoma
(urinary tract), in 13% of patients who developed skin ulcers
around the stoma, that chemical substances, infections or al-
lergic reactions were the cause.60 In the study by Salvaladena
in 2013, of the 43 adults with colostomy, 63% had peristomal
complications. The problems occurred within the period of
21–40 days after surgery. The most common skin problems
were thus skin damage and moisture related skin infection.61
The study by Pitman (2014) involved 71 stoma patients;
52%–84% of participants had at least one ostomy complica-
tion in the rst 60 days after surgery. The most commonly
reported complications were leakage (60%), dermatitis (50%),
subject pain (42%), retardation (39%), and bleeding (32%).62
In the study by Meinener et al. (2012), 3017 patients from
18 countries participated. The PUSH was used as an assess-
ment tool. The result showed that 1742 persons or about 60%
of the study participants had skin complications.20 However,
further studies are needed prior to the clinical use of Adib
herbal ointment to treat or combat colostomy skin problems.
6. CONCLUSIONS
Based on the results of this study, it can be said that Adib
herbal ointments such as Comfeel and Conveen ointments
can help heal skin ulcers around the stoma. Therefore, Adib
ointment, like other common treatments, can be used to im-
prove the skin around the stoma.
Conict of interest
The authors declared that they have no competing interests.
Funding
The nancial support for the current research was provided
by Isfahan University of Medical Sciences, Iran.
Acknowledgement
This work was supported by Student Research Center, Isfa-
han University of Medical Sciences, Iran.
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