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. 2025 Jan 9;77(3):1248–1255. doi: 10.1007/s12070-024-05312-4

Comparative Evaluation of Bilateral Cleft Earlobe Rejuvenation with and without Calendula Officinalis 10% V/W– Randomised Control Trial

Harshal Kunjir 1, Lakshmi Shetty 1,✉, Dharmendra B Sharma 2, Parth Aphale 3, Srikanth Gunturu 4, Girija Kunjir 5, Adnan F Chhatriwala 1
PMCID: PMC11909349  PMID: 40093501

Abstract

Calendula officinalis has anti microbial and anti inflammatory property and its usage for wound healing is the need of the hour. The ultimate aim of our research study was to evaluate and compare bilateral earlobe rejuvenation with and without Calendula officinalis. The purpose of the study was to examine the impact of calendula on wound healing and its effect in the duration of wound healing. This randomised control trial was conducted on patients with bilateral earlobe cleft and were advised for the treatment of earlobe repair. The technique used for repair was Cross Stitching Approach modified with subcutaneus suturing. The randomization for the calendula application and sequence was generated randomly by computer generated random numbering. Calendula ointment was placed in a double blinded manner by blinding the principal investigator and the statistician. Calendula ointment was applied every 12 hourly on one ear lobe for a period of 7 days and petroleum jelly was placed on the contralateral earlobe. Scar assessment was done using the Stony Brook Scar Evaluation Scale (SBSE) on 15th day postoperatively. The wound healing after earlobe repair in 35 patients was compared after 24 h, 7 days, and 15 days using an unpaired t test in this randomized control trial. Statistical significance was defined as a P-value of less than 0.01. The repeated measures ANOVA test was used to compare mean scores at different time intervals in groups 1 and 2. The Bon Feronic test was used to compare the mean score in groups 1 and 2 at different time intervals. Statistical significance was defined as a p-value of less than 0.01. The comparison of mean score on day 1 the (p value = 0.525), day 7 was (p value = 0.324) and day 15 which was clinically significant (p value < 0.001). Calendula ointment was found to be beneficial in wound healing after cleft earlobe repair in this study. Calendula ointment has demonstrated potential benefits in treating wounds in scheduled surgery with no post-operative problems, according to the findings of this study. This study sets the landmark for the use of Calendula ointment in the treatment of cleft earlobe rejuvenation in Maxillofacial surgery.

Keywords: Calendula ointment, Lobuloplasty, Cleft earlobe

Introduction

Cleft earlobe is the most common complication of the ear seen by the oral and maxillofacial surgeon. It typically demands surgical correction due to the aesthetic impact if left untreated. Typically, cleft earlobe results from different forms of trauma related to pierced ears or wearing earrings [1]. For religious, cosmetic, and societal reasons and universal trend, auricular lobules are pierced in several societies [2]. A partial or complete tear of the auricular lobule is a typical occurrence in women that results in cosmetic deformities. The auricular lobule, which is often conical and spherical in shape, is a crucial anatomical structure that permits women to wear jewellery such as earrings. This condition can be rejuvenated through a variety of surgical procedures [2]. Various research have been conducted on the restoration of a completely or partially torn cleft earlobe, ranging from simple earlobe suturing to complicated surgical flap procedures to restore facial attractiveness. Partial clefts can be fixed with basic suturing technique or subcutaneous suturing after refreshing the defect borders, but complete cleft earlobes are usually treated with flaps such as Z-plasty, L-plasty, or a V-shaped flap. The subcutaneous suturing technique is a straightforward, practical, and effective surgical method for producing cosmetically acceptable scars [2, 3].

Calendula officinalis Linn (Asteraceae), often known as African marigold, is a plant that is used medicinally in Europe, China, and India. Flavonoids (Quercetin and rutin), carotenoids, essential oils, saponins, carotenes, Triterpenes, Glycosides, resins, and methone, isomethone, caryophgyllene, and pedunculatine are among the ingredients. Anti-inflammatory and antiseptic characteristics, as well as anticancer, antimicrobe, and antifungal activity, antioxidant, and healing properties, are all found in this plant [4, 5]. The medicinal use includes for the treatment of wounds, first-degree burns, contusions and skin rashes [6, 7]. In India, calendula ointment is most widely used to treat caesarean wounds. Calendula has been used to repair caesarean wounds in numerous trials. However, Jahdi et al. studied the effect of calendula ointment on perineal healing following episiotomy and found that calendula ointment significantly speeds up the healing of caesarean wounds. As a result, calendula can be used to speed up the healing of wounds [5].

The ultimate aim of our research study was to evaluate and compare bilateral cleft earlobe (traumatic secondary to jewellery) rejuvenation with and without Calendula officinalis [8]. The purpose of the study was to examine the impact of calendula on wound healing and its effect in the duration of wound healing. Wound healing was assessed after 24 h, on the 7thday and on the 15th day postsuturing using the criteria including redness, edema, approximation [9, 10].

Materials and Methods

This in-vivo study was conducted on the 35 patients requiring repair of bilateral cleft earlobe (traumatic secondary to jewellery) from December 2019 to April 2021. This prospective randomized clinical split ear lobe study was conducted in Department of Oral and Maxillofacial Surgery after an ethical clearance was granted by Institutional Ethics Com mittee DYPDCH/ IEC/ (DYPDCH/IEC/123/114/19) dated 25/9/19, Research and Recognition committee clearance DPU R&R(D)/ 1184/21/2019 dated 20/12/19. [Suppl1]CTRI registration noCTRI/2022/04/042297.The patients were enrolled in the study according to ethical standards and Declaration of Helsinki and after taking written informed consent.Routine preoperative investigations such as Complete haemogram, Blood sugar level fasting and postprandial, Bleeding time, clotting time were carried out. Size of each group or sub-group was decided as site A which included ear lobe rejuvenation with the use of Calendula ointment and site B which included ear lobe rejuvenation without the use of Calendula ointment. The randomization for the calendula application and sequence was generated randomly by computer generated random numbering. The design of randomized controlled trial was adapted.

Objectives

  1. To evaluate the wound healing in bilateral earlobe rejuvenation with Calendula officinalis on day 1, 7th day, 15th day.

  2. To evaluate the wound healing in bilateral earlobe rejuvenation without Calendula officinalis on day 1, 7th day, 15th day.

  3. To compare the wound healing in bilateral earlobe rejuvenation with or without Calendula officinalis on day 1, 7th day, 15th day.

Surgical Technique

Standard scrubbing, painting and draping was done. 2% lignocaine hydrochloride without adrenaline was infiltrated in the ear lobe on anterior and posterior aspect. The anterior margins of the defect were carefully freshened using a no 15 blade. A loop knot was made before entering the needle in the subcutaneous layer. A simple rejuvenation was performed by placing subcutaneous suturing with single layer of 5 − 0 prolene. On the anterior and posterior side subcutaneous suturing was done. Excess tissue was cut and the suturing was done in subcutaneous layer using 5 − 0 prolene. Similar procedure was carried on the other earlobe.

Calendula ointment was placed every 12 hourly on one ear lobe for a healing period of 7 days and petroleum jelly was placed on the other earlobe to keep the wound moist.Patient recalled after 24 h for evaluation of pain and edema and after 7 days for assessment of healing and suture removal. Patient recalled after 15 days for assessment of wound healing. Photos were taken post operatively for the records. Scar assessment was done using SBSES (The stony brook scar evaluation scale) on 15th day postoperatively. The parameters used for the assessment of scar were The calendula ointment was applied in a double blinded manner by blinding the principal investigator and the statistician.

Data from the SBSE was entered into an Excel spreadsheet 2000, and the results were analysed with IBM SPSS software Version 21. To determine statistical significance, data was compared using specified statistical tests. The wound healing after earlobe repair was compared after 24 h, 7 days, and 15 days using an unpaired t test. Statistical significance was defined as a P-value of less than 0.01. The repeated measures ANOVA test was used to compare mean scores at different time intervals in groups 1 and 2. The Bonferroni test was used to compare the mean score in groups 1 and 2 at different time intervals. Statistical significance was defined as a p-value of less than 0.01.

Results

Comparison of mean score on day 1 showed statistically insignificant difference. As the p value = 0.525. Similarly Comparison of mean score on day 7 also showed statistically insignificant difference as the p value = 0.324. Whereas, Comparison of mean score on day 15 showed statistically significant difference as the p value was < 0.001.

Comparison of mean score in group 1 at different time interval showed statistically significant result as F = 269.944 and p value was < 0.001. Whereas the comparison between different time interval showed statistically significant difference between day 1, day 7 (P < 0.001) & day 15(P < 0.001) and day 7 & day 15(P < 0.001) in group 1.

However, in group 2 comparison of mean score in group 2 at different time interval showed statistically significant result as F = 151.33 and p value < 0.001.Whereas the comparison between different time interval showed statistically significant difference between day 1, day 7 (P < 0.001) & day 15(P < 0.001) and day 7 & day 15 (P < 0.001) in group 2. (Table 1)

Table 1.

Distribution and comparison of mean score on day 1, day 7 and 15th day

Group N Mean Std. Deviation Mean diff t P value
Day 1 1.00 35 1.5429 0.56061 0.08571 0.640 0.525
2.00 35 1.4571 0.56061
Day 7 1.00 35 2.6571 0.59125 0.14286 0.993 0.324
2.00 35 2.5143 0.61220
Day 15 1.00 35 4.6000 0.49705 0.88571 7.750 < 0.001
2.00 35 3.7143 0.45835
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Comparison of mean score on day 1 showed statistically insignificant difference (t = 0.640, p = 0.525)(Fig. 1). Whereas on day 7 showed statistically insignificant difference (t = 0.993, p = 0.324)(Fig. 2). Comparison of mean score on day 15 showed statistically significant difference (t = 7.750, p < 0.001) (Fig. 3).

Fig. 1.

Fig. 1

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Bar diagram representing mean score on day 1 (Graph 1)

Fig. 2.

Fig. 2

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Bar diagram representing mean score on day 7 (Graph 2)

Fig. 3.

Fig. 3

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Bar diagram representing mean score on day 15th (Graph 3)

Comparison of mean score in group 1 at different time interval showed statistically significant result (F = 269.944. p < 0.001) (Table 2) (Fig. 4) Comparison between different time interval showed statistically significant difference between day 1, day 7 (P < 0.001) & day 15(P < 0.001) and day 7 & day 15(P < 0.001) in group 1.

Table 2.

Comparison of mean score at different time interval in group 1

Descriptive Statistics
Mean Std. Deviation F P value
One 1.5429 0.56061 269.944 < 0.001
Seven 2.6571 0.59125
Fifteen 4.6000 0.49705
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Fig. 4.

Fig. 4

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Bar diagram representing comparison of mean score in group 1 at different time interval (Graph 4)

Comparison of mean score in group 2 at different time interval showed statistically significant result (F = 151.33, p < 0.001) (Table 3).

Table 3.

Comparison of mean score at different time interval in group 2

Descriptive Statistics
Mean Std. Deviation F P value
Day 1 1.4571 0.56061 151.337 < 0.001
Day 7 2.5143 0.61220
Day 15 3.7143 0.45835
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Comparison between different time interval showed statistically significant difference between day 1, day 7 (P < 0.001) & day 15(P < 0.001) and day 7 & day 15 (P < 0.001) in group 2. (Fig. 5)

Fig. 5.

Fig. 5

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Bar Diagram representing comparison of mean score at different time interval (Graph 5)

Discussion

Calendula, also known as Mary-Bud, Mary-Gold, Pot Marigold, and Poor Man’s Saffron, is one of the world’s oldest known flowers [11]. The plant was first mentioned in the third century BC and became famous in French gardens in the fifth century [12]. It has been cultivated for around 600 years. Calendae is the Latin term for the first day of the month [13]. Calendula officinalis possesses antiseptic, anti-inflammatory, anti-fungal, anti-cancer, anti-oxidant, and anti-microbe effects [14]. Buzzi M (2016) did a research study to analyse the impact of plenusdermax calendula officinalis spray on pressure ulcers and non-healing venus leg ulcers to investigate its anti-inflammatory action [15]. The author discovered that applying plenusdermax calendula extract spray on pressure ulcers not only cured the ulcers but also left very little scarring in the majority of patients [16]. This shows that, in addition to anti-inflammatory and antibacterial characteristics, calendula officinalis may promote fibroplasia and angiogenesis [17, 18].

Cleft earlobes come in a variety of shapes and sizes, and they are easily noticeable since they draw a lot of attention to the face [19, 20]. Congenital clefts and acquired clefts are the mainly two kinds [21]. Congenital clefts are uncommon, and acquired clefts are split into partial and complete clefts based on whether the cleft involves the lobe’s lower border [22, 23]. Wearing heavy earring for years, ageing, trauma, and mechanical reasons are the most common causes of cleft earlobe [24]. Lobuloplasty is a surgical treatment that is used to restore earlobes that have been split or ripped [25]. McLaren was the first to report the restoration of a cleft auricular lobule with a simple linear closure in 1954 [26]. Buchan NG undertook a study to develop an earlobe cleft repair technique that preserves the earlobe canal [27]. Z plasty [28], V plasty, L plasty, tongue in groove technique, cross stitching technique [29], and purse string suturing are some of the other cleft earlobe repair techniques [30]. In our trial, however no extra flap was taken in any of the patients. Patients with clefts on both earlobes were considered eligible for this study so that a comparison could be made between two earlobes in the same patient and inter person variability could be eliminated (31, 32). Gadhvi A.S. et al. (2018) used subcutaneous suturing to close the incision and they were able to achieve good cosmetic results with minimal scarring in the wound. Similarly, in our study subcutaneous suturing was done which was modified from ‘cross stitching approach’ that was described by Zilinsky I in his research work [29].

Calendula Q in 10% V/W processed in white petroleum jelly for each 10 gram content was included in the ointment’s formulation. St. Georges homoeopathy in Karnataka, India, produced the calendula ointment that we employed in our study. The patient was told to use the ointment every 12 h. After 24 h, patients were called back to check for any ongoing bleeding or pain (Fig. 6). After 24 h, there was no active bleeding or pain in any of the patients. On the first day, the wound healing was evaluated using the stony brook scar evaluation scale. Singer AJ et al. (2007) [33] conducted research to develop a new scar scale that assessed the scars for the absence or presence of the following features: scar breadth greater than 2 mm, elevation or depression, discoloration, suture or staple marks, and/or overall poor appearance (the scars were given zero to Five score) [33, 34]. (Fig. 7). The SBSE score after the 1st day of surgery was nearly identical as there was no difference between the wounds treated with calendula and those treated with petroleum jelly. The mean score was compared, and the p value for the Mann Whitney U test was p = 0.525, indicating a statistically insignificant difference. On the 7th day, the SBSE scale score on both ears was nearly identical (Fig. 8). The mean score was compared, and the difference was statistically insignificant, with a p value of 0.324 for the Mann Whitney U test. The SBSE scale scores showed a significant difference on the 15th day after surgery as the scores in site A were higher and there was a statistically significant difference p < 0.001. None of the patients experienced complications of lobuloplasty such as a large scar, recurrence of the cleft, suturing opening, or wound infection. None of these studies have looked into using calendula officinalis to treat cleft earlobes. This is a first-of-its-kind study to see how effective calendula ointment is at repairing earlobe clefts [35].

Fig. 6.

Fig. 6

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Right cleft earlobe and Left cleft earlobe

Fig. 7.

Fig. 7

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Subcutaneous suturing done on the right and left earlobe

Fig. 8.

Fig. 8

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Healing after 15 days on right earlobe (Site B) and left earlobe (Site B)

Conclusion

Calendula ointment was found to be beneficial in wound healing after cleft earlobe repair in this study. Calendula ointment has demonstrated potential benefits in treating wounds in scheduled surgery with no post-operative problems, according to the findings of this study. When applied to the operated site, calendula ointment had no side effects. This has proved to have promising potential for cleft earlobe regeneration. As a result, it could be administered in addition to traditional lobuloplasty procedures as an adjuvant ointment. This study sets the landmark for the use of Calendula Ointment in the treatment of cleft earlobe rejuvenation in Maxillofacial surgery.

Declarations

Ethical Approval

The authors declare compliance with all ethical standards.

Patient Consent

Informed written consent was obtained from the patients.

CTRI Registration No

CTRI/2022/04/042297.

Conflict of Interest

The authors declare that they have no conflict of interest.

Footnotes

Publisher’s Note

Springer Nature remains neutral with regard to jurisdictional claims in published maps and institutional affiliations.

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