Skin Graft WoundsAloePaTuNCT07057557
Aloe Vera vs Paraffin Tulle Dressings for Pain Management in Split Thickness Skin Graft Donor Sites
A study testing Aloe Vera Gel Dressing and Paraffin-Based Tulle Dressing in people with Skin Graft Wounds and Donor Site Complication, run by King Edward Medical University at 1 site in Pakistan.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Skin Graft Wounds, Donor Site Complication, Pain, Postoperative
- What is being tested?
- Aloe Vera Gel Dressing and Paraffin-Based Tulle Dressing
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 72 participants
- Where
- 1 sitePakistan
- Study dates
- 5 Aug 2025to 14 Apr 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- • Patients aged 18-60 years of age of either gender needing Split thickness skin graft
Who cannot join
- • 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Pakistan1 site, 1 recruiting
- Recruiting
Mayo Hospital Lahore
Lahore, Punjab Province
UMAR SALEEM, +923334525983, umar_saleem786@yahoo.com
About this study
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
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?
Read more
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
Read the 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.
- Being tested
- Aloe Vera Gel Dressing, Paraffin-Based Tulle Dressing
- Medical subject headings
- Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Aloe Vera Gel DressingOther
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 DressingOther
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).
| Study group | Role | What they receive |
|---|---|---|
| Aloe Vera Gel Dressing | Experimental | Participants in this group will receive Aloe Vera gel applied directly to the split-thickness skin graft donor site Receives: 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. Receives: Other: Paraffin-Based Tulle Dressing |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 7 days after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jul 2025
- Study start5 Aug 2025
- Primary completion5 Feb 2026 (estimated)
- Study completion14 Apr 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Skin Graft WoundsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 72 participants (estimated)
Sponsor and investigators
- Lead sponsor
- King Edward Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07057557
- Sponsor's protocol ID
- 396/RC/KEMU
- Acronym
- AloePaTu
- Status last verified
- Sep 2025
- First submitted
- 30 Jun 2025
- Last updated
- 25 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT07057557
- Acronym / sponsor ID
- AloePaTu / 396/RC/KEMU
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 72 participants (estimated)
- Lead sponsor
- King Edward Medical UniversityUniversity, hospital or other
- Study start
- 5 Aug 2025 (actual)
- Primary completion
- 5 Feb 2026 (estimated)
- Study completion
- 14 Apr 2026 (estimated)
- First posted
- 10 Jul 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Aloe Vera Gel Dressing | Experimental | Other: Aloe Vera Gel DressingParticipants in this group will receive Aloe Vera gel applied directly to the split-thickness skin graft donor site |
| Paraffin-Based Tulle Dressing (Conventional Dressing) | Active comparator | Other: Paraffin-Based Tulle DressingParticipants in this group will receive standard paraffin-based tulle dressing with chlorhexidine on the donor site. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- • Patients aged 18-60 years of age of either gender needing Split thickness skin graft
Key exclusion criteria (2 listed)
- • Patients known to have exaggerated/diminished pain response due to certain medical conditions (e.g. diabetes, neuropathy, chemotherapy, opioids etc.)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Aloe Vera Gel DressingParticipants 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 | Aloe Vera Gel Dressing |
| Paraffin-Based Tulle DressingParticipants 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). | Other | Paraffin-Based Tulle Dressing (Conventional Dressing) |
Primary outcome
Pain Score at Donor Site on Postoperative Day 7
Time frame: 7 days after surgery
Postoperative pain will be measured using the Visual Analogue Scale (VAS), which ranges from 0 (no pain) to 10 (worst possible pain).
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Sep 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Aloe Vera Gel Dressing and Paraffin-Based Tulle Dressing in people with Skin Graft Wounds and Donor Site Complication, run by King Edward Medical University at 1 site in Pakistan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 25 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Pakistan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain Score at Donor Site on Postoperative Day 7 (time frame: 7 days after surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Sep 2025.