To evaluate and compare the wound healing outcome of Superoxidised solution and Calendula Officinalis flower extract used for local wound care in patients of oral squamous cell carcinoma having postoperative wound dehiscence: A randomized controlled trial.
试验速览
- 阶段
- Phase 3 4
- 状态
- 已完成
- 入组人数
- 16
- 试验地点
- 1
- 主要终点
- 1)Size of wound
研究概览
简要总结
Wound dehiscence(29%) is a known complication of oral cancer surgery.They can be divided in to major and minor complications.Major complications include extended wound dehiscence which require surgical revision and minor complications include regular wound dehiscence that require only local dressings and therapy and no further surgical procedure.
The criterion to differentiate a regular or extended wound dehiscence can be the presence of dehiscent area less than or equal to two centimeter square in regular wound dehiscence.
Superoxidised solution has been used for wound healing post surgery.It moistens, lubricates ,debrides and reduces microbial load.
Similarly Calendula Officinalis flower extract has been studied for wound healing post surgery.It has antiinflammatory,antibacterial,antiviral,antifungal, proangiogenic and anti oxidant properties.There are reports of local allergy too.
A clinical trial objectively comparing the above mentioned interventions is required.
This study is a randomized ,single blind,parellel droup, mono centric trial to evaluate and compare the the wound healing outcome of superoxidised solution and Callendula Officinalis flower extract used for local wound care in patients of oral squamous cell carcinoma having post operative wound dehiscence.
The primary outcome is based on thirteen criteria of the Bates Jensen wound assessment tool .All these parameters will be evaluated on day1,5,10,15 and 21 post wound dehiscence.
the secondary outcome will be to assess if calendula can cause any local allergy.
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Participant Blinded
入排标准
- 年龄范围
- 15.00 Year(s) 至 99.00 Year(s)（—）
- 性别
- All
入选标准
- •Patients who have undergone surgical intervention for management of oral squamous cell carcinoma(OSCC) with Neck dissection 2)Patients who have a wound dehiscence of less than equal to 2 cm² post OSCC surgery 3)Patients requiring no surgical intervention for correction of wound dehiscence.
排除标准
- •Previous history of Radiotherapy & chemotherapy 2)Previous history of neck dissection 3)Recurrence of OSCC 4)Coagulation disorder 5)Patient unfit for surgery 6)Patients with known allergy to herbal medication.
结局指标
主要结局
1)Size of wound
时间窗: WOund dehiscence assessment on day1,5,10,15,20 post wound dehiscence
2)Depth of wound
时间窗: WOund dehiscence assessment on day1,5,10,15,20 post wound dehiscence
3)Edges of wound 4)Undermining 5)Necrotic tissue type
时间窗: WOund dehiscence assessment on day1,5,10,15,20 post wound dehiscence
7)Exudate type
时间窗: WOund dehiscence assessment on day1,5,10,15,20 post wound dehiscence
10)Peripheral tissue edema
时间窗: WOund dehiscence assessment on day1,5,10,15,20 post wound dehiscence
12)Granulation tissue
时间窗: WOund dehiscence assessment on day1,5,10,15,20 post wound dehiscence
13)Epithelization
时间窗: WOund dehiscence assessment on day1,5,10,15,20 post wound dehiscence
6)Necrotic tissue amount
时间窗: WOund dehiscence assessment on day1,5,10,15,20 post wound dehiscence
8)Exudate amount in wound
时间窗: WOund dehiscence assessment on day1,5,10,15,20 post wound dehiscence
9)Skin color of surrounding wound.
时间窗: WOund dehiscence assessment on day1,5,10,15,20 post wound dehiscence
11)Peripheral tissue Induration
时间窗: WOund dehiscence assessment on day1,5,10,15,20 post wound dehiscence
次要结局
- Allergy to Calendula Officinalis flower extract(On Day 1 of topical application)