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临床试验/CTRI/2024/02/063148
CTRI/2024/02/063148招募中4 期

Comparative Evaluation of Wound Healing of Knotless Barbed Absorbable Suture and Monofilament Absorbable Suture for Closure of Intraoral Incisions in Maxillofacial Trauma: A Prospective Randomized Controlled Clinical Study.

Dr Sayali More1 个研究点 分布在 1 个国家目标入组 44 人开始时间: 2024年5月3日最近更新:
适应症

试验速览

阶段
4 期
状态
招募中
发起方
入组人数
44
试验地点
1
主要终点
Wound Healing in terms of Inflammation,Proliferation and Remodelling

研究概览

简要总结

Maxillofacial surgical practice frequently involves closure of wounds which may be traumatic or surgical incisions. Currently, the options for wound closure are numerous and range from suture materials (resorbable and non-resorbable) to non-suture materials such as cyanoacrylates, fibrin glue and adhesive tapes. Nevertheless, suturing remains the most commonly employed method of wound closure in intra-oral surgery whose objectives     include the following; anatomic re-approximation of tissues, hemostasis and prevention of wound contamination through microleakage or entrapment of food. Further, for various surgical               procedures, suturing must provide an ideal tissue-seal that prevents the underlying implants or grafts from getting infected. Numerous suture materials which vary in structure and composition are currently being used for intra-oral wound closure. These require placement of knots to secure the suture material to the tissues. However, intra-oral suturing presents the        following clinical challenges related to knotting (1) Difficulty in placing the first tie and achieving the desired tissue approximation in areas of restricted access and instrumentation   such as retromolar region and palate. (2) Propensity for knot slippage which compromises wound closure and necessitates a knot holding instrument or an assistant (3) Knot related tissue irritation, and (4) Knot being a nidus for food debris and microbial               colonization. Knotless suture is a novel suture device which may be an ideal alternative to eliminate the above mentioned drawbacks. In addition, numerous knot related complications have been documented in literature such as accumulation of food debris leading to infection and soft tissue irritation and eventually wound dehiscence. Literature also reveals that knots over the wound can cause ischemia due to additional pressure which predisposes the wound to infection. Improper suturing leads to complications such as wound dehiscence, infection, and post-operative pain and hemostasis in the postoperative phase. Knotless suturing is an innovative method of wound closure used in the fields of bariatric surgery, abdominoplasty, facial rejuvenation procedures, laparoscopic myomectomy, partial nephrectomy, and in various minimally invasive procedures. The rationale of this study is to evaluate role of knotless barbed absorbable suture for intraoral wound closure in terms of wound healing compared to conventional monofilament absorbable suture.

研究设计

研究类型
Interventional
分配方式
Computer generated randomization
盲法
Not Applicable

入排标准

年龄范围
18.00 Year(s) 至 60.00 Year(s)(—)
性别
All

入选标准

  • •1.Patients indicated for intraoral incisions for access to fractures in cases with Le Fort 1 maxillary fractures,ZMC Fractures,Mandible fractures undergoing open reduction and internal fixation. 2.Age.
  • •18 to 60 Years. 3.Patients willing to be a part off the study.

排除标准

  • •1.Patients with any pre-existing systemic disease or condition, history of medication with anti-coagulants, steroids.
  • •2.Extraoral incisions 3.Contaminated wound 4.Patients diagnosed with oral submucosal fibrosis.
  • •5.Preexisting scar from previous incisions or laceration
  • •Patients not willing to be a part of the study.

结局指标

主要结局

Wound Healing in terms of Inflammation,Proliferation and Remodelling

时间窗: Inflammation will be assessed on Post-Operative Day 5,Proliferation will be assessed on Post- Operative Day 14 AND Remodelling will be assessed on Post-Operative Week 6

次要结局

  • Variation in wound healing outcomes based on Age & Site of Incision(At post operative day 5,post operative day 14 & post operative week 6)

研究者

发起方
Dr Sayali More
申办方类型
Other [Self Funded]

研究点 (1)

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