A Prospective Randomized Controlled Trial On Umbilical Granuloma Treatment With Table Salt And Silver Nitrate Solution

The condition of umbilical granuloma is one of the common conditions which is characterised by red lump of tissues, moist in nature and it is observed within the first few weeks after birth. It is stated that the area is treated with the help oof silver nitrate solution which helps in slow burning of the area and prevents the chance of developing complications (Al-Jundi & Sakka, 2017). Presently, the use of silver nitrate solution is prevalent for curing the same and used by the nurses, however, other alternative solution of salt-water can also be used for reducing the treatment cost. The following paper will critically appraise the study named- “Table Salt is An Alternative to Silver Nitrate Cautery for the Treatment of Umbilical Granuloma: A Prospective Randomized Controlled Trial” with the help of JBI checklist. Similarly, the purpose of JBI tool is to evaluate the organizational superiority of a study and to govern the degree to which a study has addressed the opportunity of prejudice in its project, behavior and examination (Jbi.global, 2022

Unclear, the researcher in this case failed in maintaining true randomisation for the assignment of the participants in the groups. No such information regarding the participants blinding or the researchers blinding was highlighted in the study. In the study, one of the outcome assessors was found to be blind while assessing the result, but no such information regarding the assessment and allocation of the participants for understanding the blinding. It is evident that the process of randomisation is considered to be the process of assigning the participants in the control and experimental group at random where each of the participants has the equal chance of allocation. The researcher in this case conducted a simple randomisation process for allocating the participants (Hariton & Locascio, 2018). 

Unclear, the researcher in this case failed in providing proper information related to the concealment of the study design.  On the other hand, it is determined that the researcher in this case conducted the study with the help of a prospective randomized controlled study with the help of a group where informed consent was provided to the parents for each of the children.  No such information related to the experimental process was found to be provided to the patient family. It is stated that in the randomized control trial study, the allocation concealment hides the sorting of the trial of the participants into the different groups so that the knowledge about the research is not exploited. A proper allocation concealment helps in preventing the participants from influencing the study result and in this case no such proper information was provided from the study related to the allocation concealment of the participants (Sil et al., 2019).

Yes, different treatment was applied in the two groups at the baseline. The researcher in this case was found to divide the groups in to two groups such as in group 1, the paediatric surgeon in the outpatient clinic applied 75% of silver nitrate solution and in group 2, the family members was found to apply small amount of table salt granules twice a day for 3 days at home. In group 1, the researcher in this case was found to clean the umbilical area with antiseptic solution and kept it for drying. In group 2, umbilical region was dressed with warm water in the table salt group and the region was kept uncovered for 30minutes. It is stated that if the randomisation process is success than the groups are similar at the baseline and it helps in determining the difference in outcome which is related to intervention group instead of confounding factor (Schulz et al., 2018).

Answer 1

NA, no such information regarding the participants blinding was noticed in the study. The study highlighted that only one of the nurses in assessing the result was blind to the treatment. However, the participants were provided with informed consent and in the second group the family members in home applied table salt granules twice after 3 days which indicated that no such proper blinding was done by the researcher while conducting the study. It can be stated that proper blinding helps the researcher to minimize the possible bias in the experiment and it might affect the study result (Matourypour et al., 2022).

NA, it can be stated that no such information was shared in the study related to the blinding of the researcher where it was found that the one of the outcome assessors was found to be blind in assessing the treatment result. However, two different professionals were found to provide treatment in two different groups. It is unclear from the study that the individual delivering treatment was found to be blind to the treatment intervention.  It can be determined that since the intervention was provided by the family member the participants were not blind with the treatment intervention which might affect the study result by increasing the biases and lowering the trustworthiness of the result. Blinding helps in eliminating bias and hence, all of the participants including the clinical staff, physicians, patient and the family member must be blind to the treatment group (Bhatia et al., 2021).

No, it is stated that only one of the independent reviewers was blind to the treatment assignment. It would have been beneficial if both the researcher were blind to the treatment group as it would have helped in improving the study result by lowering biasness. The study highlighted that the patients were contacted after 4 weeks by two independent researchers where only one researcher was blind to the intervention. Properly blinding helps in minimizing the risk of bias which might influence the research finding. It is also determined that the blinding must the proper for all the trialists included in the study (Monaghan et al., 2021).

Unclear, as the researcher failed in sharing the treatment provided to the groups were. It has been reported that in group 1, the participant’s umbilical area was cleaned with the help of antiseptic solution and it was left for drying in a proper way.  On the other hand, in group one the paediatric surgeon in the outpatient clinic was found to apply 75% of silver nitrate solution to the granuloma.  On the other hand, group 2, the family member, was responsible for cleaning the umbilical region with the help of warm water and table salt which can be considered to be the intervention group and the region was found to be covered with sterile gauze. The region was uncovered for 30minutes in group 2. The patients were also invited to the hospital for lowering the complication related to umbilical complication (Oztas et al., 2020).

Yes, the follow up of the patients in the both the groups were complete by the researcher. The researcher reported that after first week of the treatment, similar kind of treatment were applied for the second time for the patient with umbilical exudate and the treatment were similar for both the group. The researcher in this case was found to evaluate the treatment process in the second week and the follow-up was done at the same time for the two groups. The researcher also highlighted the fact the participants follow up was taken after 4 weeks after implementation of treatment with the help of telephone and two independent researchers (Oztas et al., 2020). 

Answer 2

Yes, the participants were analysed in the group by the researchers in which they were randomised initially. It is stated that in group 1 a total number of 37 participants were included in the study and in group 2, a total number of 37 participants were included in the study. The assessment was done in same time in both the group such after the first week after therapy. Hence, it can be stated that the participants were analysed in the groups in which they were randomised (Oztas et al., 2020).

Yes, it can be stated that two of the independent reviewers were found to analyse the study outcome equally in both the groups after 4 weeks of the treatment.  In group 1 the participants were provided with silver nitrate solution in the umbilical area in order to lower the prevalence of complication whereas in group 2, the researcher planned to implement common salt in order to reduce the issue of umbilical infection including complications (Oztas et al., 2020).

Unclear, the outcome was measured in a reliable way by the researchers. The research in this case was found to analyse the development of any kind of infection which is present among the patient after providing the treatment.  It is also stated that the researcher in this case was found to assess the skin discoloration and any burning sign which was present among the patient.  The researcher also documented any incident of relapses and the recovery phase was defined by the absence of any kind of umbilical granuloma or exclusion.  The researcher also clearly identified the fact that failure in treatment was defined by the presence of umbilical exudate in both the groups including the presence of granuloma after 2 weeks of providing treatment (Oztas et al., 2020).

Yes, the researcher in this case was found to analyse the data with the help of SPSS analysis and the Kolmogorov-Smirnov test was used by the researcher in order to analyse the normality distribution of the continuous data which was appropriate in this case.  the researcher also used student T-test in order to understand the difference between the variables and the study result in common salt group and silver nitrate group in order to understand the efficacy of the treatment in reducing the prevalence of the infection (Lendaro et al., 2022). 

No, the trial was not appropriate as the researcher failed in blinding the participants. The lack of blinding increased the bias of the study result which might impact its application in local settings (Wartolowska et al., 2017).

Conclusion

The above study critically analysed a research article with the help of JBI checklist. The result of the study highlighted that no such significant result was denoted in both the groups and it is also determined that table salt is one of the stable alternatives for silver nitrate for lowering the condition of umbilical granuloma.

References 

Al-Jundi, A., & Sakka, S. (2017). Critical Appraisal of Clinical Research. Journal of clinical and diagnostic research : JCDR, 11(5), JE01–JE05. https://doi.org/10.7860/JCDR/2017/26047.9942 

Bhatia, A., Appelbaum, P. S., & Wisner, K. L. (2021). Unblinding in Randomized Controlled Trials: A Research Ethics Case. Ethics & human research, 43(2), 28–34. https://doi.org/10.1002/eahr.500084 

Hariton, E., & Locascio, J. J. (2018). Randomised controlled trials - the gold standard for effectiveness research: Study design: randomised controlled trials. BJOG : an international journal of obstetrics and gynaecology, 125(13), 1716. https://doi.org/10.1111/1471-0528.15199 

Jbi.global. (2022). Checklist for Randomized Controlled Trials. Jbi.global. Retrieved 26 April 2022, from https://jbi.global/sites/default/files/2019-05/JBI_RCTs_Appraisal_tool2017_0.pdf. 

Lendaro, E., Earley, E. J., & Ortiz-Catalan, M. (2022). Statistical analysis plan for an international, double-blind, randomized controlled clinical trial on the use of phantom motor execution as a treatment for phantom limb pain. Trials, 23(1), 138. https://doi.org/10.1186/s13063-021-05962-7 

Matourypour, P., Ghorbani, A., Mahmoudi, M., Binaei, N., Manesh, H. J., Nayeri, N. D., & Bagheri, I. (2022). Blinding and Its Quality in Clinical Trials Conducted on Patients with Breast Cancer: A Systematic Review. Iranian journal of nursing and midwifery research, 27(1), 1–7. https://doi.org/10.4103/ijnmr.IJNMR_49_20 

Monaghan, T. F., Agudelo, C. W., Rahman, S. N., Wein, A. J., Lazar, J. M., Everaert, K., & Dmochowski, R. R. (2021). Blinding in Clinical Trials: Seeing the Big Picture. Medicina (Kaunas, Lithuania), 57(7), 647. https://doi.org/10.3390/medicina57070647 

Oztas, T., Dursun, A., & Bilici, S. (2020). Table Salt is An Alternative to Silver Nitrate Cautery for the Treatment of Umbilical Granuloma: A Prospective Randomized Controlled Trial. Iiste.org. Retrieved 26 April 2022, from https://iiste.org/Journals/index.php/JSTR/article/view/51840.

Schulz, K. F., Chalmers, I., Altman, D. G., Grimes, D. A., Moher, D., & Hayes, R. J. (2018). ‘Allocation concealment’: the evolution and adoption of a methodological term. Journal of the Royal Society of Medicine, 111(6), 216-224.https://doi.org/10.1177/0141076818776604 

Sil, A., Kumar, P., Kumar, R., & Das, N. K. (2019). Selection of Control, Randomization, Blinding, and Allocation Concealment. Indian dermatology online journal, 10(5), 601–605. https://doi.org/10.4103/idoj.IDOJ_149_19 

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