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

NCT ID: NCT07057557

Last Updated: 2025-09-25

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 72 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-08-05
• Study Completion Date: 2026-04-14

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.

Conditions

Skin Graft Wounds; Donor Site Complication; Pain, Postoperative; Skin Transplantation

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Aloe Vera Gel Dressing

Participants in this group will receive Aloe Vera gel applied directly to the split-thickness skin graft donor site

Group Type: EXPERIMENTAL

Aloe Vera Gel Dressing

Intervention Type: OTHER

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).

Paraffin-Based Tulle Dressing (Conventional Dressing)

Participants in this group will receive standard paraffin-based tulle dressing with chlorhexidine on the donor site.

Group Type: ACTIVE_COMPARATOR

Paraffin-Based Tulle Dressing

Intervention Type: OTHER

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).

Interventions

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).

Intervention Type: 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).

Intervention Type: OTHER

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

King Edward Medical University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Mayo Hospital Lahore

Lahore, Punjab Province, Pakistan

Site Status: RECRUITING

Countries

Pakistan

Facility Contacts

UMAR SALEEM

Role: primary

umar_saleem786@yahoo.com

+923334525983

Other Identifiers

396/RC/KEMU

Identifier Type: -

Identifier Source: org_study_id