A prospective randomized study comparing harmonic scalpel versus electro cautery for harvesting of pectoralis major myocutaneous flap in oral cancer reconstruction
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 104
- 试验地点
- 1
- 主要终点
- Blood loss during flap harvesting
研究概览
简要总结
Demographic and clinical details of the patients will be captured on a structured proforma. After wide excision of the primary disease and neck dissection PMMC flap is harvested
Skin paddle marking and raising subcutaneous skin flap in both arms done with scalpel and electro cautery respectively
In Arm I myocutaneous flap elevation is done using Harmonic FOCUS shear connected to Ultrascision Harmonic generator 300(J&J) which is calibrated at power 3 and power 5. The lateral edges of the muscle pedicle are not sutured.In Arm II electrocautery is used for myocutaneous flap tissue.The edges of muscle are sutured with absorbable suture after securing hemostasis.After elevation the flap is transferred on to the neck and the wounds are sutured with correct approximation and separate drainage kept for the neck and chest operative sites.The blood loss during flap harvesting is measured by the difference of the pre operative (Y) and post operative weight (X) of mops used during harvesting of the flap. ( X – Y) / 1.055(sp gravity blood) = volume of blood in ml.Daily monitoring of the drains with measurement done in milliliters from the neck and chest separately and drain is removed when less than 50 ml .The cumulative volume drain volume of both neck and chest drain is recorded up to the time of removal of drain.Complication sought for at chest wound and flap recipient site1) Hematoma 2) Seroma 3) Skin infection 4) Flap vascularity changes – partial/complete
ANALYSIS - Statistical analysis by Student t test to assess significant difference between two groups for quantitative variables such as blood loss and post operative drain.The Chi-Square test for categorical variant difference between two groups such as Hematoma, Seroma, Skin infection, Flap vascularity changes partial or complete. A P.05 was considered statistically significant.
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Participant 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
- •INCLUSION CRITERIA •Oral cancer patients requiring PMMC flap for reconstruction after surgery •Patients age 18 to 70 •An ECOG performance score of 0-1 •Fit to undergo general anesthesia •Patient willing to give a valid informed consent for the procedure.
排除标准
- •EXCLUSION CRITERIA • Blood dyscrasias / altered coagulation profile • Known case of Collagen vascular disease • Diabetes or hypertension of more than 15 years duration • Infection in chest wall or lower neck • Any prior surgery on chest wall • Any history of radiation to chest wall.
结局指标
主要结局
Blood loss during flap harvesting
时间窗: Blood loss during flap harvesting, per operative | Drains output measurement, post operative | Complication sought for at chest wound and flap recipient site | in post operative period before discharge | Hematoma | Seroma | Skin and subcutaneous infection | Flap vascularity changes – | partial/complete
Flap vascularity changes –
时间窗: Blood loss during flap harvesting, per operative | Drains output measurement, post operative | Complication sought for at chest wound and flap recipient site | in post operative period before discharge | Hematoma | Seroma | Skin and subcutaneous infection | Flap vascularity changes – | partial/complete
partial/complete
时间窗: Blood loss during flap harvesting, per operative | Drains output measurement, post operative | Complication sought for at chest wound and flap recipient site | in post operative period before discharge | Hematoma | Seroma | Skin and subcutaneous infection | Flap vascularity changes – | partial/complete
Drains output measurement
时间窗: Blood loss during flap harvesting, per operative | Drains output measurement, post operative | Complication sought for at chest wound and flap recipient site | in post operative period before discharge | Hematoma | Seroma | Skin and subcutaneous infection | Flap vascularity changes – | partial/complete
Complication sought for at chest wound and flap recipient site
时间窗: Blood loss during flap harvesting, per operative | Drains output measurement, post operative | Complication sought for at chest wound and flap recipient site | in post operative period before discharge | Hematoma | Seroma | Skin and subcutaneous infection | Flap vascularity changes – | partial/complete
Hematoma
时间窗: Blood loss during flap harvesting, per operative | Drains output measurement, post operative | Complication sought for at chest wound and flap recipient site | in post operative period before discharge | Hematoma | Seroma | Skin and subcutaneous infection | Flap vascularity changes – | partial/complete
Seroma
时间窗: Blood loss during flap harvesting, per operative | Drains output measurement, post operative | Complication sought for at chest wound and flap recipient site | in post operative period before discharge | Hematoma | Seroma | Skin and subcutaneous infection | Flap vascularity changes – | partial/complete
Skin and subcutaneous infection
时间窗: Blood loss during flap harvesting, per operative | Drains output measurement, post operative | Complication sought for at chest wound and flap recipient site | in post operative period before discharge | Hematoma | Seroma | Skin and subcutaneous infection | Flap vascularity changes – | partial/complete
次要结局
未报告次要终点