ROLE OF HEPARIN TO PREVENT HYPERTROPHIC SCARNIG IN DONOR AREA OF SPLIT THICKNESS SKIN GRAFT
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 400
- 试验地点
- 1
- 主要终点
- Incidence of hypertrophic scarring at STSG donor site
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 2 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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
结局指标
主要结局
Incidence of hypertrophic scarring at STSG donor site
时间窗: 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.
次要结局
- Donor site pain(10th post-operative day, 1 month, and 3 months)
研究者
Asma Ishtiaq
DR
Dr. Ruth K.M. Pfau Civil Hospital, Karachi