Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-24 @ 7:08 PM
Ignite Modification Date:
2025-12-24 @ 7:08 PM
NCT ID:
NCT07057557
Brief Summary:
The goal of this clinical trial is to learn if Aloe Vera gel dressing helps reduce pain better than traditional paraffin-based tulle dressing at the donor site of split-thickness skin grafts in adult patients aged 18 to 60. The main questions it aims to answer are:
Does Aloe Vera gel dressing reduce postoperative pain more effectively than paraffin-based tulle dressing on the 7th day after surgery?
Is there a difference in the need for additional pain medication between the two groups?
Researchers will compare Aloe Vera gel dressing to paraffin-based tulle dressing to see if Aloe Vera leads to better pain control.
Participants will:
Undergo split-thickness skin graft surgery
Receive either Aloe Vera gel dressing or paraffin-based tulle dressing at the donor site
Have pain measured using a visual analogue scale (VAS) on the 7th day after surgery
Be given pain medication if their pain score is 4 or higher, and the amount used will be recorded
Detailed Description:
This randomized controlled trial aims to evaluate the effectiveness of Aloe Vera gel dressings compared to conventional paraffin-based tulle dressings in reducing postoperative pain at the donor site of split-thickness skin grafts (STSG). The study will be conducted in the Department of Plastic Surgery, Mayo Hospital, Lahore, over a period of six months.
Split-thickness skin grafting is a common reconstructive surgical procedure. Although effective, it creates a donor site wound that often causes significant postoperative pain, potentially affecting patient recovery and satisfaction. While paraffin-based tulle dressings are widely used, they may not offer optimal pain relief. Aloe Vera gel, due to its anti-inflammatory, analgesic, and wound-healing properties, is a promising alternative that has shown benefit in burn wounds and other superficial skin injuries.
A total of 72 patients (aged 18-60 years, of either gender) requiring STSG will be enrolled and randomized into two equal groups:
Group A will receive Aloe Vera gel dressings applied directly to the donor site.
Group B will receive conventional paraffin-based tulle dressings.
Both groups will undergo secondary dressing using dry gauze and crepe bandages. All procedures will be performed under general anesthesia, and grafts will be harvested at a uniform thickness (0.25-0.30 mm) using an electric dermatome.
Pain will be assessed using the Visual Analogue Scale (VAS) on postoperative day 7. Analgesic use (specifically nalbuphine) will be recorded for patients reporting a VAS score ≥4. The primary outcome is the difference in mean pain scores between the two groups; secondary data includes the total analgesic consumption.
This study will provide evidence on whether Aloe Vera gel dressing is a more effective alternative to conventional dressing in managing donor site pain following skin grafting, potentially improving patient outcomes and influencing future dressing protocols.
Study:
NCT07057557
Study Brief:
Protocol Section:
NCT07057557