Pyogenic granuloma (PG) is an acquired benign proliferation of capillaries in the skin and mucosa; [1]nevertheless, the word is misleading as the lesion is neither infectious in origin nor granulomatous in histological composition. PG can manifest at any age, however it is predominantly observed in children and young people. Both males and females are impacted, although females are more commonly afflicted, possibly due to the vascular influences of estrogen and progesterone.[2] We document the whole resolution of a PG lesion and the mitigation of related symptoms in a 53-year-old female patient subsequent to the at-home use of topical salt.

Study Design

A prospective cohort study was conducted to compare the effectiveness of radiofrequency cautery ablation versus the use of common salt application in the management of pyogenic granuloma.

Study Setting and Duration

The study was carried out at the Department of Dermatology, Venereology, and Leprosy, M.G.M.M.C. & M.Y. Hospital, Indore, Madhya Pradesh. The study was conducted over a period of 12 months, from January 1, 2023, to December 31, 2023, after obtaining ethical approval from the Institutional Ethics Committee.

Study Population

Patients presenting to the outpatient department (OPD) with cutaneous pyogenic granuloma were considered for inclusion in the study.

Inclusion Criteria

• All consenting adults diagnosed with cutaneous pyogenic granuloma.

Exclusion Criteria

• Cases of mucosal pyogenic granuloma.
• Patients on systemic or topical immunosuppressive drugs, antiretroviral drugs, antineoplastic drugs, or undergoing any treatment for pyogenic granuloma.

Sample Size Calculation

The sample size was calculated based on the prevalence of pyogenic granuloma, estimated at 0.5% of all skin nodules in children (Joseph C. Pierson et al., 2020). Using Lwanga & Lameshow’s formula (2000) for sample size determination in a cross-sectional survey:

N=(Z2∗P∗Q)/D2N = (Z^2 * P * Q) / D^2

Where:

• Z = 1.96 (corresponding to a 95% confidence interval)
• P = 0.5 (proportion with disorder)
• Q = 1 - P = 0.5 (proportion without disorder)
• D = 2% (margin of error)

Calculated sample size = 48, approximated to 50 for convenience.

A convenient sampling technique was employed, with patient recruitment occurring from 8 AM to 2 PM in the OPD. Patient recruitment ceased upon completion of the 12-month study duration.

Study Procedure

Eligible patients were randomized into two groups using a web-based randomization application or Microsoft Excel.

• Group A: Patients received radiofrequency cautery ablation (RFC).
• Group B: Patients were treated with common salt application.

Treatment Protocol

1. Radiofrequency Cautery Ablation (RFC)
• The lesion was anesthetized using a local injection of lignocaine with adrenaline.
• Radiofrequency cautery was applied to ablate the lesion.
2. Common Salt Application
• White soft paraffin was applied over the perilesional skin.
• A sufficient quantity of common salt was applied to cover the entire lesion.
• The area was occluded using a cotton gauze and surgical adhesive tape.

All patients were followed up for three months to assess:

• Complete resolution of the lesion
• Scarring
• Recurrence of the lesion

Data Collection

• A detailed history and clinical examination were performed for each subject, including demographic data (age, gender, occupation) and etiological factors.
• Treatment procedures were explained to all patients, and they were given the option to choose their preferred method.
• Informed consent was obtained before enrollment in the study.

Statistical Analysis

• Data from 50 subjects were recorded and analyzed using SPSS version 22.0.
• Continuous variables were presented as Mean ± Standard Deviation (Min-Max).
• Categorical variables were presented as numbers (%).
• Frequency distributions were used for data categorization.
• Normality of data was assessed, and appropriate parametric/non-parametric tests were applied.
• Chi-square test or Fisher’s exact test was used for categorical variable association.
• Student t-test or ANOVA test was applied for comparing means and medians.
• A P-value <0.05 was considered statistically significant.

Table:1 Distribution of Study Population by Age Group, Gender, and History of Trauma

The study population consisted of 50 individuals, distributed across different age groups. The highest proportion (38.0%) belonged to the 15-25 years age group, followed by 26.0% in the 25-35 years group. The majority of participants were male (78.0%), while females made up 22.0% of the population. Regarding the history of trauma, 58.0% had a trauma history, while 8.0% were on associated medication.

Table:2 Distribution of Study Population by Site of Lesions, Size of Lesions, and Associated Symptoms

Among the study population, lesions were most commonly found on the head (54.0%), followed by extremities (30.0%) and trunk (14.0%). Regarding lesion size, 84.0% were larger than 10mm, while 16.0% were smaller than 10mm. Associated symptoms varied, with the majority experiencing bleeding (80.0%), while 24.0% reported pain and 12.0% were asymptomatic.

Table:2 Distribution of Study Characteristics

The study population was evenly divided between two treatment methods—Radiofrequency Cautery (RFC) and Common Salt—each used in 50.0% of cases. Healing outcomes after 14 days showed that 84.0% of patients had complete healing, while 16.0% experienced partial healing. After one month, 90.0% had no scarring, while 10.0% developed scarring. At the three-month mark, 92.0% had no recurrence, with only 8.0% experiencing recurrence. Statistical analysis revealed no significant association between the type of treatment and lesion site (p > 0.05) or lesion size (p = 1.000), indicating that both treatments were equally effective across different lesion locations and sizes.

Table: Association between Treatment and Healing Duration

The association between treatment type (RFC vs. Common Salt) and healing outcomes was analyzed. After 14 days, both treatments resulted in 84.0% complete healing and 16.0% partial healing, with no significant difference between them (p = 1.000). However, after one month, the presence of scarring was significantly different between the two groups (p = 0.018). While 100.0% of patients treated with Common Salt had no scarring, 20.0% of those treated with RFC experienced scarring, suggesting that Common Salt might be more effective in preventing scarring.

Pyogenic granuloma (PG) is a prevalent, acquired, benign vascular tumor of the skin and mucous membranes. It predominantly manifests in children and teenagers. First-line treatment modalities for pyogenic granuloma are predicated on destructive techniques. Potential risks of these procedures include pain, irreversible scarring, and pigmentation (Piraccini et al., 2016). [4]

Determining the optimal treatment is challenging, as most studies do not conduct direct comparisons between therapies. Basic surgical excision is linked to a little risk of recurrence, however frequently results in a conspicuous scar. Curettage or shave excision with cautery is more likely to achieve success in a single session compared to cryotherapy, and both methods may result in less scars than surgical intervention. Laser treatment, perhaps necessitating numerous sessions, and sclerotherapy are least likely to result in noticeable scarring. Untreated pyogenic granulomas have spontaneous regression between 6 to 18 months, accompanied by a potential risk of scarring.

Salt has lately been identified as a therapeutic option for PG. Daruwalla et al. documented a case in which a pinch of salt was administered to a lesion, soft white paraffin was applied to the lesion periphery to avert perilesional skin irritation, and the lesion was then sealed with surgical adhesive tape. The resolution of the PG transpired after 7 to 14 days of therapy, with no recurrence seen at the one-month follow-up. [3]

Rubaian NF et al. observed that the lesion totally disappeared within two weeks after the application of salt.[5] Salt application is an effective treatment for pyogenic granuloma, considering the lesion formation locations, the patient's youth, the lack of scarring, and the high rate of total lesion clearance.[6]Aside from a mild, reversible stinging sensation during application, salt treatment presents no complications; thus, it is suitable for children, patients reluctant to undergo surgical excision, areas where cauterization is challenging, or extensive lesions necessitating reduction prior to excision.[5]

Nevertheless, there is a scarcity of research demonstrating the effectiveness of salt administration in the treatment of pyogenic granuloma. This prospective cohort research involved 50 patients of both genders and diverse ages to evaluate the efficacy of radiofrequency cauterization against topical common salt in treating pyogenic granuloma, as well as to compare the recurrence rates in both study groups.The patients were evenly distributed between the two therapy groups and were randomly assigned. Group A consisted of patients administered RFC, whereas Group B included patients treated with ordinary salt.

The majority of patients in the research were in the 15-25 years age group (38%), followed by 25-35 years (26%), 35-45 years (20%), under 15 years (12%), and the least represented group was 45-55 years (4%). Daruwalla et al. conducted a similar research, revealing that the majority of patients were in the 15-30 age range (27), followed by 15 patients aged 1-15 years and 8 patients aged 30-50 years. [6] Patra AC et al. indicated that the total mean age of the study population was 30.2 ± 13.51 years, with no significant difference in mean age between the two treatment groups (P = 0.426). [7]

The current investigation revealed a greater prevalence of men compared to females, namely [39(78%)] vs [11(22%)]. The male to female ratio was 3.5:1. Patra AC et al. identified a greater prevalence of pyogenic granuloma in males than in females in their investigation. [7]

In the current investigation, the majority of patients had a history of trauma [29(58%)], followed by those using related medications [4(8%)]. The predominant location of lesions was the head (54%), followed by the extremities (30%) and the trunk (14%) of patients, respectively. Daruwalla et al. revealed that the most prevalent locations for single PGs were the scalp (n = 17), lip (n = 14), limbs (n = 14), face (n = 4), and genitalia (n = 1). This resembled our study. [4] In a comparable research, Patra C et al. reported The prevalent locations of involvement were the face (27.5%), lateral nailfold (22.5%), palm or sole (22.5%), and scalp (20%). [7]

A statistically insignificant difference was seen between the therapy and the location of lesions. P > 0.05 The study revealed no significant disparity in the incidence of cases for Head, Trunk, and Pain Symptoms between RFC Treatment and Common Salt Treatment. The head therapy accounted for 48.0% of cases, the trunk treatment for 16.0%, and the pain symptom treatment for 36.0%. Both treatments exhibited 60.0% and 24.0% incidence rates, respectively.
The majority of the lesions [42(84%)] in our analysis exceeded 10 mm in size, while the remainder [8(16%)] were smaller than 10 mm. A statistically insignificant difference was seen between the therapy and the duration of lesions. P > 0.05 In both groups, the predominant lesions were those above 10 mm, specifically 84% in the RFC group and 84% in the common salt group. In a comparable research conducted by Daruwalla et al., the average size was 15.5 mm (ranging from 6 to 25 mm). A statistically significant positive association was seen between lesion size and the duration required for full clearance (r = 0.69, P < 0.001). This was analogous to the findings of our investigation. [4]

The most often reported symptom was bleeding [40 (80%)], followed by pain [12 (24%)], while the remaining patients [6 (12%)] were asymptomatic. A statistically insignificant difference was seen between the therapy and the related symptoms of lesions. (P > 0.05) Daruwalla et al. documented Complete clearance of the lesion without residual scarring was observed in 100% of patients, and 94% reported a reduction in the lesion's bleeding tendency as an instant reaction. The average duration for resolution completion was 14.77 days. [4]Among the patients treated with common salt, the majority, 42 (84%), claimed complete recovery, while 8 (16%) reported partial healing after 14 days of therapy. After one month, the majority of patients, 45 (90%), reported no scarring, whereas 5 (10%) reported scarring. Recurrence was seen in 46 (92%) individuals, whereas 4 (8%) did not report recurrence. Daruwalla et al. (2021) reported full clearance of the lesion without any remaining scarring in 100% of instances. A relapse was observed in one patient after 11 months of remission. This was analogous to the findings of our investigation. [4]A non-significant difference was noted between the treatment outcomes after 14 days and the study groups. Complete recovery was observed in 21 (84%) patients in both groups, while partial healing was documented in 4 (8%) patients in each group. After one month of treatment, a notable disparity was noted between the treatment groups, with 5 (20%) patients in the RFC group experiencing scarring, while no patients in the common salt group reported similar effects. P = 0.018. After three months of therapy, two (8%) patients in each group exhibited recurrences, whereas no recurrences were observed in 23 (92%) patients in each treatment group. The correlation between the groups was not significant.

A case report by Daruwalla et al. described a patient with a lesion that fully disappeared within two weeks with the application of salt, soft white paraffin, and surgical adhesive tape. The patient's lesion did not reappear at the 1-month follow-up, indicating the efficacy of salt and paraffin in addressing skin irritation. This was consistent with our research. [6]
In 2021, Daruwalla et al. observed a statistically significant positive association between lesion size and the duration required for full clearance (r = 0.69, P < 0.001). A modest positive association existed between patient age and time to full resolution, however it was not statistically significant (r = 0.19, P = 0.18). This was analogous to our study. [4]
In conclusion, the administration of common salt for the treatment of pyogenic granuloma shown significant effectiveness, resulting in full healing of all lesions without scarring and minimum recurrence. Due to its relative ease of application, absence of scarring, and remarkable efficacy resulting in complete resolution, we regard salt application as an optimal treatment for pyogenic granuloma (PG), particularly in children, pregnant women, anxious patients, and in instances of PG recurrence or when PG develops secondary to chemotherapeutic agents.

It is important to confirm the accurate diagnosis of PG. Upon confirmation of the diagnosis by a dermatologist, salt therapy may be administered at home, accompanied by regular evaluations until remission is achieved. This study's shortcomings encompass the random enrollment of patients and a limited sample size, which diminish its statistical power. The absence of a plateau in improvement by six weeks necessitates extended study. We exclusively incorporated early-onset pyogenic granulomas, and the impact of common salt on chronic pyogenic granulomas requires assessment.

This prospective cohort study compared the effectiveness of Radiofrequency Cautery (RFC) ablation and common salt application in the treatment of pyogenic granuloma. The findings indicate that both treatment modalities achieved high rates of complete healing, with no significant difference in healing outcomes after 14 days. However, common salt application demonstrated a notable advantage in preventing post-treatment scarring, as no patients in this group experienced scarring after one month, whereas 20% of those treated with RFC did (p = 0.018). Recurrence rates at three months were low and comparable between both groups (8%).

Common salt application emerges as a highly effective, minimally invasive, and cost-efficient treatment option for pyogenic granuloma. It offers the advantages of ease of application, absence of scarring, and high patient compliance, making it particularly suitable for children, pregnant women, and individuals reluctant to undergo invasive procedures. While RFC remains a reliable treatment, the potential for scarring suggests that salt application may be preferable in cases where cosmetic outcomes are a priority.

Despite the promising results, the study's limitations include a small sample size and relatively short follow-up duration. Further large-scale studies with longer follow-up periods are needed to validate the long-term efficacy of salt therapy, particularly in chronic or recurrent cases. Nonetheless, our findings support the consideration of common salt as a first-line treatment for pyogenic granuloma, given its effectiveness, accessibility, and favorable safety profile.

1. Plachouri, K., and S. Georgiou. "Therapeutic Approaches to Pyogenic Granuloma: An Updated Review." International Journal of Dermatology, vol. 58, 2018, pp. 642-648.
2. Erbaşar, G. N. H., B. Şengüven, S. E. Gültekin, et al. "Management of a Recurrent Pyogenic Granuloma of the Hard Palate with Diode Laser: A Case Report." Journal of Laser Medical Sciences, vol. 7, 2016, pp. 56-61.
3. Alessandrini, A., F. Bruni, M. Starace, and B. M. Piraccini. "Periungual Pyogenic Granuloma: The Importance of the Medical History." Skin Appendage Disorders, vol. 1, no. 4, May 2016, pp. 175-178.
4. Daruwalla, S. B., S. Ghate, and R. Dhurat. "Establishing the Efficacy and Safety of the Novel Use of Common Salt for the Treatment of Pyogenic Granuloma." Clinical and Experimental Dermatology, vol. 46, no. 7, 2021, pp. 1243-1247. doi:10.1111/ced.14658.
5. Bin Rubaian, N. F. "Complete Resolution of a Refractory Pyogenic Granuloma Following Topical Salt Treatment." Open Access Emergency Medicine, vol. 13, 2021, pp. 445-448. https://doi.org/10.2147/OAEM.S323793.
6. Daruwalla, S. B., and R. S. Dhurat. "A Pinch of Salt Is All It Takes! The Novel Use of Table Salt for the Effective Treatment of Pyogenic Granuloma." Journal of the American Academy of Dermatology, vol. 83, no. 2, 2020, pp. e107–e108. doi:10.1016/j.jaad.2019.12.013.
7. Patra, A. C., A. Sil, S. K. S. Ahmed, S. Rahaman, N. Mondal, S. Roy, et al. "Effectiveness and Safety of 0.5% Timolol Solution in the Treatment of Pyogenic Granuloma: A Randomized, Double-Blind and Placebo-Controlled Study." Indian Journal of Dermatology, Venereology and Leprology, vol. 88, 2022, pp. 500-508.