Menu
Recruiting NCT07057557

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

No phase Interventional Skin Graft Wounds Donor Site Complication Pain, Postoperative Skin Transplantation

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Aloe Vera Gel Dressing, Paraffin-Based Tulle Dressing.
Who it may be relevant to
Registry conditions: Skin Graft Wounds, Donor Site Complication, Pain, Postoperative, Skin Transplantation. Basic parameters: 18 years — 60 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Pakistan
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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

Overview

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.

Interventions

  • 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).
  • 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).

Primary outcome measures

  • Pain Score at Donor Site on Postoperative Day 7 [Time frame: 7 days after surgery]

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Treatment

Study locations

Pakistan · 1 center
  • Mayo Hospital Lahore — Lahore

Identifiers

NCT: NCT07057557 · 396/RC/KEMU

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗