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临床试验/CTRI/2025/01/079098
CTRI/2025/01/079098尚未招募不适用

Comparison of the appearance of postoperative scars following the use of electrocautery versus scalpel in elective mid line abdominal skin incisions a randomized controlled trial

AIIMS Patna1 个研究点 分布在 1 个国家目标入组 140 人开始时间: 2025年1月31日最近更新:

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
140
试验地点
1
主要终点
To compare the post operative wound scar appearance following the use of electrocautery versus scalpel in mid line abdominal skin incision based on a structured and validated Vancouver scar scale scoring system

研究概览

简要总结

This study targets patients scheduled for elective midline abdominal incisions ranging from 5 to 10 cm in length who meet the specified inclusion criteria and voluntarily provide informed consent For cases where the incision length exceeds 10 cm data will still be included in the intention to treat  analysis but such cases will be excluded from the per protocol analysis Prior to the procedure all patients will undergo thorough health assessments to evaluate their fitness for surgery They will also receive detailed information about the two incision methods including the associated benefits and risks  ensuring they can make an informed decision Once consent is obtained each patients demographic and clinical details will be recorded in a pre designed data collection form

To ensure randomization patients will be allocated to one of two groups using sealed envelopes opened only after the induction of anesthesia by a non-study staff member to maintain blinding Participants in Group A will have their skin incision performed using a 35 W electrocautery device in cut mode Erbe VIO 300 S 2018 while those in Group B will have their incision made with a scalpel For both groups the subcutaneous tissue and linea alba will be incised using electrocautery in cutting mode with coagulation mode employed as needed for haemostasis  All patients will receive standardized preoperative antibiotics to minimize infection risk  and skin closure will be carried out uniformly using 3 0 nylon sutures

Blinding measures are integral to the study design Both the patients and the follow up surgeon will remain unaware of the incision method used The follow up surgeon who is independent of the surgical team will be responsible for assessing outcomes to eliminate bias The study will evaluate several key parameters including intra operative metrics like incision time and blood loss per unit wound area Postoperative outcomes will focus on pain levels measured daily using the Visual Analogue Scale  from day 1 to day 5 and surgical site infection rates assessed on the 30th postoperative day in accordance with CDC guidelines If required wound cultures will be performed to identify any infectious agents At four months scar quality will be examined using two standardized tools the Vancouver Scar Scale  for physical appearance and the Patient and Observer Scar Assessment Scale  for comprehensive quality assessment

Follow up visits are scheduled for day 30 and four months post-surgery For patients discharged earlier remote evaluations will be conducted via photographs or teleconsultations with in person visits arranged for cases requiring closer examination At the four month follow up scars will be thoroughly assessed during an outpatient appointment by the blinded follow up surgeon

研究设计

研究类型
Interventional
分配方式
Randomized
盲法
Participant, Investigator and Outcome Assessor Blinded

入排标准

年龄范围
18.00 Year(s) 至 70.00 Year(s)(—)
性别
All

入选标准

  • Age group 18 to 70 years Willing to participate Incision length 5 to 10 cm ASA class I and II Clean or clean contaminated surgical wounds as classified by the American College of Surgeons Committee on Control of Surgical Infections.

排除标准

  • Patients with a preexisting scar at the planned surgical incision site Patient who has a known predilection for hypertrophic or keloid scars Known case of connective tissue disorders BMI greater than 30 On immunosuppressive therapy History of chemotherapy within the last 2 weeks before surgery and or radiotherapy of the abdomen within last 8 weeks before surgery.

结局指标

主要结局

To compare the post operative wound scar appearance following the use of electrocautery versus scalpel in mid line abdominal skin incision based on a structured and validated Vancouver scar scale scoring system

时间窗: 4 months

次要结局

  • To measure and compare the mean incision time per unit wound area in seconds per square centimeter following the use of electrocautery versus scalpel in mid line abdominal skin incision(intra operative period)
  • To measure and compare the blood loss during incision time following the use of electrocautery as opposed to scalpel in mid line abdominal skin incision by utilizing weighing in gram mes the sterile gauze pieces before and after the usage of electrocautery versus scalpel(intraoperative period)
  • To score the postoperative pain utilizing the Visual Analogue Scale on postoperative days 1 to 5(postoperative days 1 to 5)
  • To assess and compare the 30 day postoperative wound infection rates using the CDC guidelines for Surgical Site Infections following the use of electrocautery versus scalpel in mid line abdominal skin incision(1 month)
  • To compare the postoperative wound scar appearance both subjectively and objectively following the use of electrocautery versus scalpel in mid line abdominal skin incision based on a structured and validated The Patient and Observer Scar Assessment Scale(4 months)

研究者

发起方
AIIMS Patna
申办方类型
Research institution and hospital
责任方
Principal Investigator
主要研究者

Dr Toufiq Hassan K

all india institute of medical sciences patna

研究点 (1)

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