Aloe Vera vs Paraffin Tulle Dressings for Pain Management in Split Thickness Skin Graft Donor Sites (AloePaTu)

Comparison of Postoperative Pain After Application of Aloe Vera Gel Dressings With Conventional Paraffin-Based Tulle Dressings at Split-Thickness Skin Graft Donor Site

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

Study Overview

• Status: Recruiting
• Conditions: Pain, Postoperative; Donor Site Complication; Skin Transplantation; Skin Graft Wounds
• Intervention / Treatment: Other: Aloe Vera Gel Dressing; Other: Paraffin-Based Tulle Dressing

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 Type: Interventional
• Enrollment (Estimated): 72
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Pakistan
  • Punjab Province
    • Lahore, Punjab Province, Pakistan
      • Recruiting
      • Mayo Hospital Lahore
      • Contact: UMAR SALEEM; Phone Number: +923334525983; Email: umar_saleem786@yahoo.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• • Patients aged 18-60 years of age of either gender needing Split thickness skin graft

Exclusion Criteria:

• • Patients known to have exaggerated/diminished pain response due to certain medical conditions (e.g. diabetes, neuropathy, chemotherapy, opioids etc.)

  • Patients allergic to either dressings

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Aloe Vera Gel Dressing; Participants in this group will receive Aloe Vera gel applied directly to the split-thickness skin graft donor site	Other: Aloe Vera Gel Dressing; Participants in this arm will receive Aloe Vera gel applied directly to the split-thickness skin graft (STSG) donor site immediately after graft harvesting. The Aloe Vera gel will be applied in a sterile manner, followed by secondary dressing with dry gauze and crepe bandage. Pain will be assessed on postoperative day 7 using the Visual Analogue Scale (VAS).
Active Comparator: Paraffin-Based Tulle Dressing (Conventional Dressing); Participants in this group will receive standard paraffin-based tulle dressing with chlorhexidine on the donor site.	Other: Paraffin-Based Tulle Dressing; Participants in this arm will receive a conventional paraffin-based tulle dressing impregnated with chlorhexidine applied to the STSG donor site. The dressing will be followed by secondary coverage with dry gauze and crepe bandage. Pain will be assessed on postoperative day 7 using the Visual Analogue Scale (VAS).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pain Score at Donor Site on Postoperative Day 7	Postoperative pain will be measured using the Visual Analogue Scale (VAS), which ranges from 0 (no pain) to 10 (worst possible pain).	7 days after surgery

Collaborators and Investigators

• Sponsor: King Edward Medical University

Study record dates

Study Major Dates

• Study Start (Actual): August 5, 2025
• Primary Completion (Estimated): February 5, 2026
• Study Completion (Estimated): April 14, 2026

Study Registration Dates

• First Submitted: June 30, 2025
• First Submitted That Met QC Criteria: June 30, 2025
• First Posted (Actual): July 10, 2025

Study Record Updates

• Last Update Posted (Estimated): September 25, 2025
• Last Update Submitted That Met QC Criteria: September 21, 2025
• Last Verified: September 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Pain, Postoperative; aloe vera gel extract hydrogel dressing
• Other Study ID Numbers: 396/RC/KEMU

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No