Hypertrophic ScarringHepScarNCT07196358
Topical Heparin for Prevention of Hypertrophic Scarring in Split-Thickness Skin Graft Donor Sites
A study testing Standard dressing and Topical Heparin Dressing in people with Hypertrophic Scarring and Pain, Postoperative, run by Dr. Ruth K.M. Pfau Civil Hospital, Karachi at 1 site in Pakistan.
Trial summary
This study is testing whether applying a special dressing soaked with heparin (a medicine that improves blood flow and reduces scar formation) can help prevent thick, raised scars (called hypertrophic scars) and reduce pain at the site where skin is taken for a split-thickness skin graft. Read more about this study
- Who is it for?
- Ages 2 years and older
- Conditions the study is for
- Hypertrophic Scarring, Pain, Postoperative, Wound Healing
- What is being tested?
- Standard dressing and Topical Heparin Dressing
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 400 participants
- Where
- 1 sitePakistan
- Study dates
- 15 Aug 2024to 10 Sep 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 2 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Patients of age 2 years and above, of any gender.
- Patients requiring a split-thickness skin graft.
- Patients giving informed consent for study participation.
- Patients with serum albumin > 3 g/dL.
Who cannot join
- Patients allergic to heparin.
- Patients with diabetes, hematological disorders, kidney or liver diseases, or malignancies.
- Patients on medications affecting wound healing.
- Patients with existing hypertrophic scarring at the donor site
Trial locations and contacts
1 site in 1 country.
Pakistan1 site
Plastic & Reconstructive Surgery Department, Ruth Pfau Civil Hospita
Karachi, Sindh
About this study
Official title: ROLE OF HEPARIN TO PREVENT HYPERTROPHIC SCARNIG IN DONOR AREA OF SPLIT THICKNESS SKIN GRAFT
This study is testing whether applying a special dressing soaked with heparin (a medicine that improves blood flow and reduces scar formation) can help prevent thick, raised scars (called hypertrophic scars) and reduce pain at the site where skin is taken for a split-thickness skin graft. When people need skin grafts for burns, injuries, or other conditions, the area where the skin is taken (donor site) can sometimes heal with painful or raised scars. In this study, each patient will have one donor site treated with the standard dressing and the other site treated with heparin dressing. We will compare how the wounds heal, the amount of pain, and whether scars develop over a 3-month period. The goal is to see if this simple, low-cost method can improve healing and reduce scarring for patients needing skin grafts.
Read the detailed description
Hypertrophic scarring at the donor site of split-thickness skin grafts (STSG) is a common problem that can cause pain, itching, discomfort, and cosmetic concerns. Conventional donor site dressings allow healing but do not specifically address scar prevention. Heparin has anti-inflammatory and anti-fibrotic properties, improves local blood circulation, and may reduce the formation of raised scars. Previous research has suggested a role for topical heparin in burn wound management, but its effect on STSG donor sites has not been adequately studied.
This study is an open-label, randomized controlled trial conducted in the Plastic \& Reconstructive Surgery Department at Ruth Pfau Civil Hospital, Dow University of Health Sciences. A total of 200 patients requiring STSG will be enrolled. Each patient will provide two donor sites (both thighs). One site will receive the standard paraffin gauze dressing, while the other will receive a heparin-soaked gauze dressing prepared by diluting heparin 5000 IU/mL with saline to achieve a 500 IU/mL solution. Dressings will remain in place until postoperative day 10 unless earlier change is required.
The primary outcome is the incidence and severity of hypertrophic scarring at the donor site, assessed using the Vancouver Scar Scale at 3 months. Secondary outcomes include donor site pain (measured by Numeric Rating Scale), analgesic requirements, and wound complications. Patients will be followed up at day 10, 1 month, and 3 months.
The study aims to determine whether topical heparin is an inexpensive, safe, and effective method to improve healing and prevent hypertrophic scarring in resource-limited settings, potentially changing standard practice for donor site management.
- Conditions
- Hypertrophic Scarring, Pain, Postoperative, Wound Healing
- Being tested
- Standard dressing, Topical Heparin Dressing
- Keywords
- Hypertrophic Scar Split-Thickness Skin Graft (STSG) Donor Site Wound Healing Topical Heparin Scar Prevention Vancouver Scar Scale Pain Management
- Medical subject headings
- Cicatrix, Hypertrophic, Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Standard dressingOther
Intervention Description: Donor site of STSG treated with standard dressing. Wound is cleaned, paraffin gauze applied, covered with gauze pieces and bandaged. Dressing is removed on the 10th post-operative day, or earlier if excessive exudate is present. Pain and wound healing monitored per standard care protoco
Topical Heparin DressingOther
Intervention Description: Donor site of STSG treated with heparin dressing. 5 ml of 5000 IU/ml heparin is diluted in 50 ml normal saline to produce 500 IU/ml concentration. Gauze is soaked in this solution and applied to donor site immediately after graft harvest. Dressing remains in place until 10th post-operative day unless clinical indication requires earlier change. Pain, wound healing, and hypertrophic scarring assessed during follow-up.
| Study group | Role | What they receive |
|---|---|---|
| Arm 1: Standard Dressing | Active comparator | Description: Donor site of STSG treated with standard dressing (paraffin gauze, gauze pieces, bandaged) as per hospital protocol. Dressing removed on 10th post-operative day unless clinically indicated earlier. Receives: Other: Standard dressing |
| Heparin Dressing | Experimental | Description: Donor site of STSG treated with heparin-soaked gauze (5 ml 5000 IU/ml heparin diluted in 50 ml saline to 500 IU/ml concentration) applied immediately post-harvest, dressing left in place till 10th post-operative day unless clinically indicated earlier. Receives: Other: Topical Heparin Dressing |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of hypertrophic scarring at STSG donor site
Hypertrophic scarring will be measured using the Vancouver Scar Scale, which evaluates vascularity, height, pliability, and pigmentation. Total score ranges from 0-13. Comparison will be made between the standard dressing and heparin dressing groups.
Measured: Assessed at 10th post-operative day, 1 month, and 3 months
Secondary outcomes (1)
Donor site pain
Pain will be assessed using the Numeric Rating Scale (0-10), where 0 indicates no pain and 10 indicates worst pain. Daily analgesic requirement will also be documented.
Measured: 10th post-operative day, 1 month, and 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Sep 2025
- Study start15 Aug 2024
- Primary completion30 Aug 2025
- Study completion10 Sep 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hypertrophic ScarringStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This is an open-label, parallel-group randomized controlled trial. Participants will act as their own controls, with one thigh receiving a heparin-soaked dressing (intervention) and the other thigh receiving the standard dressing (control). This design allows for direct comparison of hypertrophic scarring and pain outcomes at donor sites under different dressing protocols while controlling for individual patient variability. The intervention will be applied immediately after split-thickness skin graft harvesting and maintained according to the study protocol.
- Masking
- None (open label)
- Enrolment
- 400 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dr. Ruth K.M. Pfau Civil Hospital, Karachi
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Asma Ishtiaq, Dr. Ruth K.M. Pfau Civil Hospital, Karachi
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07196358
- Sponsor's protocol ID
- DUHS-185
- Other IDs
- IRB-3459-DUHS/Approval-2024-18
- Acronym
- HepScar
- Status last verified
- Sep 2025
- First submitted
- 21 Sep 2025
- Last updated
- 29 Sep 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- ROLE OF HEPARIN TO PREVENT HYPERTROPHIC SCARNIG IN DONOR AREA OF SPLIT THICKNESS SKIN GRAFT
- ClinicalTrials.gov ID
- NCT07196358
- Acronym / sponsor ID
- HepScar / DUHS-185
- Conditions
- Hypertrophic Scarring, Pain, Postoperative, Wound Healing
- Keywords
- Hypertrophic Scar Split-Thickness Skin Graft (STSG) Donor Site Wound Healing Topical Heparin Scar Prevention Vancouver Scar Scale Pain Management
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 400 participants (actual)
- Lead sponsor
- Dr. Ruth K.M. Pfau Civil Hospital, KarachiOther government
- Study start
- 15 Aug 2024 (actual)
- Primary completion
- 30 Aug 2025 (actual)
- Study completion
- 10 Sep 2025 (actual)
- First posted
- 29 Sep 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.
This study is testing whether applying a special dressing soaked with heparin (a medicine that improves blood flow and reduces scar formation) can help prevent thick, raised scars (called hypertrophic scars) and reduce pain at the site where skin is taken for a split-thickness skin graft. When people need skin grafts for burns, injuries, or other conditions, the area where the skin is taken (donor site) can sometimes heal with painful or raised scars. In this study, each patient will have one donor site treated with the standard dressing and the other site treated with heparin dressing. We will compare how the wounds heal, the amount of pain, and whether scars develop over a 3-month period. The goal is to see if this simple, low-cost method can improve healing and reduce scarring for patients needing skin grafts.
Detailed description
Hypertrophic scarring at the donor site of split-thickness skin grafts (STSG) is a common problem that can cause pain, itching, discomfort, and cosmetic concerns. Conventional donor site dressings allow healing but do not specifically address scar prevention. Heparin has anti-inflammatory and anti-fibrotic properties, improves local blood circulation, and may reduce the formation of raised scars. Previous research has suggested a role for topical heparin in burn wound management, but its effect on STSG donor sites has not been adequately studied.
This study is an open-label, randomized controlled trial conducted in the Plastic \& Reconstructive Surgery Department at Ruth Pfau Civil Hospital, Dow University of Health Sciences. A total of 200 patients requiring STSG will be enrolled. Each patient will provide two donor sites (both thighs). One site will receive the standard paraffin gauze dressing, while the other will receive a heparin-soaked gauze dressing prepared by diluting heparin 5000 IU/mL with saline to achieve a 500 IU/mL solution. Dressings will remain in place until postoperative day 10 unless earlier change is required.
The primary outcome is the incidence and severity of hypertrophic scarring at the donor site, assessed using the Vancouver Scar Scale at 3 months. Secondary outcomes include donor site pain (measured by Numeric Rating Scale), analgesic requirements, and wound complications. Patients will be followed up at day 10, 1 month, and 3 months.
The study aims to determine whether topical heparin is an inexpensive, safe, and effective method to improve healing and prevent hypertrophic scarring in resource-limited settings, potentially changing standard practice for donor site management.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- This is an open-label, parallel-group randomized controlled trial. Participants will act as their own controls, with one thigh receiving a heparin-soaked dressing (intervention) and the other thigh receiving the standard dressing (control). This design allows for direct comparison of hypertrophic scarring and pain outcomes at donor sites under different dressing protocols while controlling for individual patient variability. The intervention will be applied immediately after split-thickness skin graft harvesting and maintained according to the study protocol.
| Arm | Type | Receives |
|---|---|---|
| Arm 1: Standard Dressing | Active comparator | Other: Standard dressingDescription: Donor site of STSG treated with standard dressing (paraffin gauze, gauze pieces, bandaged) as per hospital protocol. Dressing removed on 10th post-operative day unless clinically indicated earlier. |
| Heparin Dressing | Experimental | Other: Topical Heparin DressingDescription: Donor site of STSG treated with heparin-soaked gauze (5 ml 5000 IU/ml heparin diluted in 50 ml saline to 500 IU/ml concentration) applied immediately post-harvest, dressing left in place till 10th post-operative day unless clinically indicated earlier. |
Who may qualify
- Ages
- 2 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- Patients of age 2 years and above, of any gender.
- Patients requiring a split-thickness skin graft.
- Patients giving informed consent for study participation.
- Patients with serum albumin > 3 g/dL.
Key exclusion criteria (4 listed)
- Patients allergic to heparin.
- Patients with diabetes, hematological disorders, kidney or liver diseases, or malignancies.
- Patients on medications affecting wound healing.
- Patients with existing hypertrophic scarring at the donor site
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 |
|---|---|---|
| Standard dressingIntervention Description: Donor site of STSG treated with standard dressing. Wound is cleaned, paraffin gauze applied, covered with gauze pieces and bandaged. Dressing is removed on the 10th post-operative day, or earlier if excessive exudate is present. Pain and wound healing monitored per standard care protoco | Other | Arm 1: Standard Dressing |
| Topical Heparin DressingIntervention Description: Donor site of STSG treated with heparin dressing. 5 ml of 5000 IU/ml heparin is diluted in 50 ml normal saline to produce 500 IU/ml concentration. Gauze is soaked in this solution and applied to donor site immediately after graft harvest. Dressing remains in place until 10th post-operative day unless clinical indication requires earlier change. Pain, wound healing, and hypertrophic scarring assessed during follow-up. | Other | Heparin Dressing |
Primary outcome
Incidence of hypertrophic scarring at STSG donor site
Time frame: Assessed at 10th post-operative day, 1 month, and 3 months
Hypertrophic scarring will be measured using the Vancouver Scar Scale, which evaluates vascularity, height, pliability, and pigmentation. Total score ranges from 0-13. Comparison will be made between the standard dressing and heparin dressing groups.
1 secondary outcome
Donor site pain
Time frame: 10th post-operative day, 1 month, and 3 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Sep 2025.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Standard dressing and Topical Heparin Dressing in people with Hypertrophic Scarring and Pain, Postoperative, run by Dr. Ruth K.M. Pfau Civil Hospital, Karachi 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 4 inclusion and 4 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: finished, as of the sponsor's last update on 29 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of hypertrophic scarring at STSG donor site (time frame: Assessed at 10th post-operative day, 1 month, and 3 months). 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 29 Sep 2025.