Ignite Creation Date:
2025-12-24 @ 7:08 PM
Ignite Modification Date:
2026-01-05 @ 1:17 PM
Study NCT ID:
NCT07057557
Status:
RECRUITING
Last Update Posted:
2025-09-25
First Post:
2025-06-30
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Aloe Vera vs Paraffin Tulle Dressings for Pain Management in Split Thickness Skin Graft Donor Sites
Sponsor:
King Edward Medical University
Organization:
Study Overview
Official Title:
Comparison of Postoperative Pain After Application of Aloe Vera Gel Dressings With Conventional Paraffin-Based Tulle Dressings at Split-Thickness Skin Graft Donor Site
Status:
RECRUITING
Status Verified Date:
2025-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
AloePaTu
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
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.
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 Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: