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

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
72

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Aug 2025

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 30, 2025

Completed
10 days until next milestone

First Posted

Study publicly available on registry

July 10, 2025

Completed
26 days until next milestone

Study Start

First participant enrolled

August 5, 2025

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 5, 2026

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 14, 2026

Completed
Last Updated

September 25, 2025

Status Verified

September 1, 2025

Enrollment Period

6 months

First QC Date

June 30, 2025

Last Update Submit

September 21, 2025

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (2)

Aloe Vera Gel Dressing

EXPERIMENTAL

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

Other: Aloe Vera Gel Dressing

Paraffin-Based Tulle Dressing (Conventional Dressing)

ACTIVE COMPARATOR

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

Other: Paraffin-Based Tulle Dressing

Interventions

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).

Aloe Vera Gel 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).

Paraffin-Based Tulle Dressing (Conventional Dressing)

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Mayo Hospital Lahore

Lahore, Punjab Province, Pakistan

RECRUITING

MeSH Terms

Conditions

Pain, Postoperative

Interventions

aloe vera gel extract hydrogel dressing

Condition Hierarchy (Ancestors)

Postoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and SymptomsPainNeurologic ManifestationsSigns and Symptoms

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 30, 2025

First Posted

July 10, 2025

Study Start

August 5, 2025

Primary Completion

February 5, 2026

Study Completion

April 14, 2026

Last Updated

September 25, 2025

Record last verified: 2025-09

Locations