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Therapeutic effect of copper sulphate vs common salt (table/cooking salt) on umbilical granuloma in infants: a comparative study.

INTRODUCTION: Umbilical granuloma is the most common umbilical abnormality in the neonate. (1) Umbilical granulomas commonly come to attention of parents because of persistent drainage or moisture involving the umbilicus after the cord has dried and separate. The umbilical cord normally separate within 7 to 10 days post portum. (2) In complete epithelialization over the fibromuscular ring of umbilicus can lead to a beefy red tissue or granulation tissue over the umbilicus. This normal granulation tissue of the resolving umbilical stump of a new born should disappear by the [2.sup.nd] or [3.sup.rd] week of the life after proper hygiene. Granualation tissue can over grow at the umbilicus can result in an umbilical granuloma. It contains no nerves and has no feeling (1, 3). Persistence of the granuloma beyond this time will need some type of therapy. (4)

The aetiology of umbilical granuloma is related to how well the tissue is healing during the drying up process, but the exact cause is unknown. (5)

Differential Diagnosis:

1. Umbilical Polyp.

2. Urachal Anomaly (Bladder communication).

3. Omphalomesenteric duct anomaly (Bowel communication).

4. Umbilical Mass: a-Ectopic pancrease, b-Umbilical Hernia.

At present the therapeutic options for umbilical granuloma are:

1. Chemical cauterization with silver nitrate or copper sulphate.

2. Topical application of common salt / 82% ethanol or Clobetasolpropionte.

3. Electric cauterization.

4. Cryocauterization.

5. Surgical excision.

6. Double ligature technique.

The conventional method is to do chemical cauterization with 75% silver nitrate stick or solution and copper sulphate., can cause minor burns in the peri-umbilical skin area. (6) When we consider the advantages and disadvantages of the therapeutic options (Like Silver nitrate application Electric cauterization, Cryocauterization, Surgical excision, Double ligature technique) are associated with increased cost, time consuming, requiring technical skills and their risks (Like bleeding and burns). Whereas common salt application is not associated with the above said complications and easy to apply (9, 10, 11, 12) In our study we procured copper sulphate commercially available goldsmiths and is also devoid with complications with the said 10 minutes contact time over umbilical granuloma of This study address the successful treatment of umbilical granuloma with a single local application of copper sulphate with less recurrence rate than with that of common salt (Table/ Cooking salt) local application.

MATERIALS AND METHODS: This is a prospective study conducted at a private clinic between September' 2007 to November' 2014. A total of 84 infants (2 weeks to 4 months), both male and female with clinically evident umbilical granuloma who sought treatment in the outpatient department of Paediatrics. The babies enrolled were divided into 2 groups and 44 infants were included in copper sulphate group and 40 infants in common salt group.

The author used the routine commercially available common salt, (Table / cooking salt) and copper sulphate procured from goldsmiths (30 gms copper sulphate for 10 rupees) For the copper sulphate group of infants the author himself involved in the application of powdered copper sulphate as per the procedure described and for the common salt group of infants the first application of a pinch of common salt was done in the outpatient clinic as per the procedure described and the mothers were asked to apply a small pinch of common salt over the umbilical granuloma twice a day for 3 days.

Both the group were evaluated in the outpatient department after 1 week, 3 weeks and 1 month to see the effect of copper sulphate versus common salt on umbilical granuloma and to note any recurrence. The response was graded as:

a) excellent response--complete regression, no discharge, heal with complete epithelialization

b) No. response /partial response no regression of umbilical granuloma, persistent umbilical discharge.

Procedure for copper sulphate / common salt application over umbilical granuloma (7): Cleanse umbilical area when soiled with urine or faeces. Keep the umbilical area clean and dry. Expose the umbilical area to the air by rolling back the top of the nappy Clean and Dry Skin of any umbilical exudates with sterile gauze and then a pinch of copper sulphate powder/a pinch of common salt (table/ cooking salt) over the umbilical granuloma basing on the chosen group for the infant. Cover the area with sterile gauze and adhesive tapes and held it in place for 10 minutes for copper sulphate group and 30 minutes common salt group. Thereafter, the lesion would be cleansed using cotton ball soaked in boiled water/normal saline. The procedure was repeated twice a day for three consecutive days for common salt group of infants.

RESULTS: Table-1 Age Group distribution (n=84), Table-2 Sex distribution (n=84), Table-3 Sex distribution among copper sulphate group and common salt group (n=84), Table-4 Response to treatment in copper sulphate group (Total Number of patients 44), Table-5 Response to treatment in common salt group (Total Number of patients 40), Table-6 Comparison of response to treatment in the 2 groups at the end of 1st week.

DISCUSSION: Umbilical swelling and discharges are common in paediatric practice and may challenge the doctor's diagnostic acumen (7). The umbilical granuloma is the most common umbilical problem in infants. If umbilical granuloma remains untreated it could ooze and become an irritation for several months (7). There are many treatment modalities of umbilical-granuloma such as chemical cauterization, electrocauterization, cryocauterization and surgical excision. Though all modalities of treatment had curative effect but each method have advantage and disadvantage. Cauterization with silver nitrate and copper sulphate may cause minor burn of peri-umbilical skin area (8) which is painful, cryo-cautery is expensive and complex, foul discharge and failure rates were higher with electro-cautery and surgical removal need general anaesthesia and rarely required.

The natural regression of the untreated umbilical granuloma has not being documented. So there is a research for an agent which is without any complication and has a curative effect. In this situation common salt (table/ cooking salt) is a suitable agent for the treatment of umbilical granuloma. Common salt is potent, has no side effect, cost effective and easily available. Encouraged with the experience of others we have also used common salt (Table salt) on our study population.

Total 84 infants were included in our study. Age ranges from 2 weeks to 4months. In literature the incidence of umbilical granuloma is same in both male and female (4), but in our study slight male preponderance (M: F=1.17:1) noted.

Out of total 84 infants 44 were included in copper sulphate group and 42 infants had excellent response with single application and remaining 2 infants required a second application and found to have excellent response after 1 week. In the second group of total 40 infants included i.e., common salt group 22 infants had excellent response after 1week and 10 infants took 3 weeks to have excellent response. Further 8 infants had no/ partial response at the end of 3 weeks.

Our study has revealed that a single copper sulphate application for umbilical granuloma resulted in 95.5% (42 out of 44) cure rate and 4.5% (2 out of 44) of infants required a second application of copper sulphate. They too have excellent response (cure) at the end of 1 week after [2.sup.nd] application. Hence in our study the copper sulphate group had 100% cure rate. Coming to the common salt group 22 infants (55%) out of 40 had excellent response at the end of [1.sup.st] week and 10 infants (25%) out of 40 had excellent response at the end of [3.sup.rd] week. But 8 infants (20%) out of 40 from common salt group had no response/partial response.

Umbilical granuloma is minor condition and can be effectively and easily managed by local application of copper sulphate/ common salt (table salt). The umbilical granuloma treated with common salt (table salt) usually clears within three weeks. If a complete cure is not affected within this time surgical advice should be obtained. (5) But in our study we tried copper sulphate application for the 8 infants with no / partial response in common salt group and followed. All the 8 infants had excelled response at the end of 1 week. The curative mechanism of copper sulphate is believed to be due to chemical cautery over the umbilical granuloma.

The curative mechanism of salt when used in the treatment of umbilical granuloma is thought to be through its desiccant effect and other biologic properties; the high concentration of sodium ion in the area draws water out of the cells and results in shrinkage and necrosis of the wet granulation tissue. However this effect is not so powerful as to cause damage to normal surrounding cornified tissue when applied for a short treatment duration. (10)

When we compared the outcome after 1week, copper sulphate showed better response as compared to common salt(The Chi square value = 16.738, ODDS ratio = 17.18, Confidence interval = 3.64-80.89 and p value is < 0.01(highly significant)) and the difference between the response of copper sulphate and common salt was found to be statistically significant.

Unlike conventional treatment with 75% silver nitrate, which may cause peri-umbilical skin burns and cloth staining and need several applications and should be treated by physician, (10) in our study both copper sulphate and common salt does not have such complications and in our study we found that umbilical granuloma is curable with copper sulphate as well as common salt topical application with no complications in either group but for more number of applications, longer duration of treatment and higher recurrence or failure rate in infants with common salt applications. Further we have encountered parental anxiety, resistance and embracement for common salt application at home.

CONCLUSION: We conclude that application of copper sulphate to the umbilical granuloma is a simple, highly effective and in-expensive form of treatment without any relapse and complications and is superior to common salt in the treatment of umbilical granuloma.

DOI: 10.14260/jemds/2015/228

REFERENCES:

(1.) O'Donnell KA, Glick PL, Caty MG. Pediatric Umbilical Problems. Pediatric Clinics of North America 1998; 45: 791-99.

(2.) Vicente H (ed). Pediatric Surgery Update January 2004; Vol-22 (3), pp 65-66 (online).

(3.) The Cochrane Library, issue 3. Chichester; John Wiley & Sons Ltd, 2004 14 Wakefield M, Banham D, Mc Caul K, et al.

(4.) Schmitt BD. Tip of the month, Shrinking umbilical granulomas. Consultant 1972; 12: 91.

(5.) Annals of Tropical Paediatrics; International Child Health, Volume 26, Number 2, June 2006, PP. 133-135 (3).

(6.) Pomeranz A. Anomalies, Abnormalities and Care of the umbilicus. Pediatric Clin North Am 2004; 51: 819-27. Wilson CB, Orch HD, Dassel's A, Ochs UH. When umbilical cord separation delayed. J Pediatr 1985; 107: 92-294.

(7.) Campbell J, Beasly SW, McMullin N, Hutson JM. Clinical diagnosis of umbilical swelling and discharge in children. The Medical Journal of Australia 1986; 145: 450-53.

(8.) Chamberlain JM, Garman RL, Young GM, Losek JD. Silver nitrate burns following treatment for umbilical granuloma. Pediatric Emergency Care 1992; 8: 29-30. Sheth SS, Malpani.

(9.) Kesaree N, Babu PS, Banapumath CR, Krishramurity SN. Umbilical granuloma. Indian Pediatrics 1983; 20: 690-92.

(10.) Bristol North Primary Care Trust. Care of the umbilical Granuloma. Clinical Guidelines, Nov. 2006.

(11.) Derakhsan MR. Curative effect of common salt on umbilical granuloma. Ira J Med Science 1998; 23: 132-33.

(12.) Phatak AT, Nagurkar PN. Umbilical granuloma. Indian Pediatrics 1985; 22: 545.

D. Annapurna [1], P. Ramu [2]

AUTHORS:

[1.] D. Annapurna

[2.] P. Ramu

PARTICULARS OF CONTRIBUTORS:

[1.] Assistant Professor, Department of Pharmacology, Andhra Medical College, Visakhapatnam.

[2.] Assistant Professor, Department of Paediatrics, Andhra Medical College, King George Hospital, Visakhapatnam.

NAME ADDRESS EMAIL ID OF THE CORRESPONDING AUTHOR:

Dr. D. Annapurna, Door No. 14-1-122/13, FF-3, Rajasagi Residency, Nowroji Road, Maharanipeta, Visakhapatnam-530002, Andhra Pradesh. E-mail: drpramu73@gmail.com

Date of Submission: 08/01/2015.

Date of Peer Review: 09/01/2015.

Date of Acceptance: 22/01/2015.

Date of Publishing: 30/01/2015.
Table 1: Age Group distribution (n=84)

   AGE GROUP      NUMBER OF   PERCENTAGE
                  PATIENTS

  < 2 Months         69         82.14
  2-4 Months         15         17.86

Table 2: Sex distribution (n=84)

  SEX      NUMBER OF   PERCENTAGE
           PATIENTS

  MALE        45         53.57
 FEMALE       39         46.43

Table 3: Sex distribution among copper sulphate group and common
salt group (n=84)

  SEX      Copper sulphate     Common salt
              group(44)         group(40)
          NUMBER OF PATIENTS

 MALE             25               20
FEMALE            19               20

Table 4: Response to treatment in copper sulphate group (Total
Number of patients 44)

Response to treatment with       Number of   Percentage
single Application at the end    patients
of 1st week of treatment

* Excellent response                42         95.5%

Number of patients required          2          4.5%
[2.sup.nd] time copper
sulphate application

* Excellent response = umbilicus returned normal

Table 5: Response to treatment in common salt group (Total Number
of patients 40)

 Response to treatment                        Number of   Percentage
   (With twice a day                          patients
 application for 3 days
  of treatment) at the
   end of first week

                            At the end of        22           55
Number of patients with       first week
  * Excellent response      At the end of        10           25
                           [3.sup.rd] week
                        Number of patients wit    8           20

* Excellent response = umbilicus returned normal

Table 6: Comparison of response to treatment in the 2 groups at
the end of 1st week

Response to treatment    Copper sulphate    %     Common salt   %
at the end of 1st week     group(44)               group(40)
                            NUMBER OF
                            PATIENTS

  Excellent response           42          95.5       22        55
     No response/               2          4.5        18        45
   partial response
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Title Annotation:ORIGINAL ARTICLE
Author:Annapurna, D.; Ramu, P.
Publication:Journal of Evolution of Medical and Dental Sciences
Article Type:Report
Date:Feb 2, 2015
Words:2234
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