Xanthelasma palpebrarum (XP) is the most common cutaneous form of xanthoma which is usually characterized by yellowish plaques over eyelids (1) and can be associated with dyslipidemia (2). Several treatment modalities including surgical excision , topical use of acids like trichloroacetic acid (TCA), but there is no consensus in literature yet regarding the best treatment modality (3).

 Surgical excision remains a safe and effective therapeutic modality for XP which is a simple effective procedure and yields good cosmetic outcome.

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Rationale

Surgical excision in the eyelid region presents a combination of unique advantages and challenges due to its distinct anatomical characteristics. These include pronounced skin laxity, an exceptionally thin subcutaneous layer, and the close proximity to the globe and other vital ocular structures.
Due to the natural laxity of the eyelid skin and the minimal subcutaneous tissue, primary wound closure is frequently achievable without the need for buried sutures. However, putting buried suture may offer advantage of reducing skin tension further and facilitating placement of advanced suturing techniques like running subcuticular non- absorbable suture.  

Novelty

While various suture techniques have been evaluated in dermatologic surgery, no trials have evaluated the scar outcomes of different closure techniques in xanthelasma excision.To bridge this gap, we propose a split-face randomized controlled trial to compare the scar outcome of bilayered closure with buried absorbable suture and superficial running subcuticular non-absorbable suture versus monolayered closure with simple interrupted non-absorbable suture in the surgical excision of XP.

Expected outcome

Bilayered closure may lead to a better scar quality, smoother contour, and improved aesthetic appearance.

 Methodology:

This double blinded split face pilot randomized controlled trial will be carried out in the department of Dermatology & STD, at Jawaharlal Institute of Postgraduate Medical Education and Research (JIPMER), Puducherry. The study will be carried out after approval of the PGRMC and JIPMER institutional Ethics Committee. CTRI registration will be done. Informed consent will be taken from patients willing to participate and fulfilling to inclusion/exclusion criteria prior to the recruitment in the study.

Patients presenting bilateral XP with involvement of at least both of the upper eyelids or both of the lower eyelids fulfilling the inclusion and exclusion criteria  and willing to participate in the study will  be  recruited  from  the  out-patient  clinic  of  the  department  of  dermatology.

 Randomization Method

 In patients with XP lesions involving both upper eyelids, the XP lesions of upper eyelid of one eye will be randomized into one treatment group, and the XP lesions of contralateral upper eyelid into the other group using computer-based randomization. The same approach will be applied if both lower eyelids are involved.

If all four eyelids are affected in a patient, separate randomization will be conducted for the both upper eyelids followed by both lower eyelids. The pair of upper eyelids will be numbered and randomized first in that patient, followed by randomization of the pair of lower eyelids.

Computer-generated randomization using variable block sizes of four or six will be implemented to ensure balanced allocation in a 1:1 ratio between the two treatment groups.

In this randomization process:

The first outcome in block randomization indicates that XP lesions on the upper or lower eyelid of the left eye will be assigned to Group A, and the corresponding eyelid(that is, the upper eyelid. if the upper eyelid was randomized to  Group A, or the lower eyelid if the lower eyelid was randomized to Group A)  of the right eye will be assigned to Group B.

The second outcome indicates that XP lesions on the upper or lower eyelid of the right eye will be assigned to Group A, and the corresponding eyelid of the left eye to Group B.

Randomization and allocation will be carried out by senior dermatology residents (X and Y), who are not involved as investigators in the study.

Treatment administration will be performed by Investigator 2.
Outcome assessment will be conducted by two independent blinded observers, to minimize bias.

 Pre-treatment Evaluation

All patients will undergo history-taking, clinical examination, and documentation of demographic and clinical details. XP lesions will be assessed for site, size, area, morphology, and colour. Lesion size will be measured with a vernier calliper, and area calculated using the paper marking method.

Baseline screening for diabetes and hyperlipidaemia (fasting and postprandial blood glucose, fasting lipid profile) will be performed. Patients with abnormal results will receive appropriate management, and follow-up tests will be repeated during subsequent visits.

Surgical Procedure

All XP lesions on the recruited eyelids will be excised completely under local anesthesia and aseptic precautions.

Group A: Bilayered closure

For XP lesions randomized into group A, primary closure will be done in two layers—first with buried vertical mattress sutures using absorbable 6-0 polyglactin 910 or poliglecaprone 25, followed by a running subcuticular suture with 6-0 polypropylene for precise skin edge approximation.

Group B: Single layer closure

 For XP lesions randomized into group-B, primary closure will be done in a single layer using 6-0 polypropylene simple interrupted sutures.

 Postoperative Care

The length of the surgical closure line will be measured after excision. Postoperatively, petrolatum and a sterile dressing will be applied. Patients will be advised to avoid eyelid rubbing or excessive movement. Dressings will be changed on alternate days until suture removal, which will be done on day 7. Patients will also be instructed to avoid sun exposure for 3 months using sunscreen and protective measures (caps, hats, sunglasses) and to refrain from any cosmetic procedures on the treated area until study completion.

Sample size - 40 pairs of eyelids. ( 80 eyelids)

Study End Point and Follow-Up

Patients will be reviewed at 8, 16, and 24 weeks to assess healing, recurrence, and complications. The primary endpoint is at 24 weeks. Any recurrence during follow-up will be documented, and patients may choose further treatment after study completion. Reminders for visits will be sent 48–72 hours in advance by phone, SMS, or WhatsApp, with up to three contact attempts before declaring loss to follow-up.