Prospective Randomized Clinical Trial Comparing Outcomes of Secondary Intention Wound Care Methods
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Lahey Clinic
- 入组人数
- 8
- 试验地点
- 1
- 主要终点
- Time to healing
研究概览
简要总结
This is a randomized controlled trial which is designed to determine whether aggressive and frequent debridement of an acute post-surgical wound shortens healing time.
详细描述
Secondary intention is an established method of allowing post-surgical defects to heal. Previous studies have shown a positive association between the frequency of debridement and healing rates in chronic wounds. However, the effect of debridement on acute, post-surgical wounds is not well-described in the literature.
This randomized controlled trial is designed to determine whether aggressive and frequent debridement of an acute post-surgical wound shortens healing time.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
盲法说明
Blinded investigator will assess photographs of completely healed wounds
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Dermatology patients at Lahey Clinic:
- •who have undergone Mohs surgery or excision
- •who are older than 18 years
- •who are able to give consent
- •who had postoperative defects allowed to heal by secondary intention on the a) head and neck, b) trunk and upper extremities, c) lower extremities
- •who are willing and able to return to clinic in Peabody, MA, for all wound care visits
排除标准
- •Unable to consent (due to language barrier or mental status)
- •Unable to perform daily wound care
- •Unwilling or unable to return for follow-up
- •Have baseline venous stasis or pitting edema of the affected limb
- •Wear compression stockings or require use of a compressive bandage (such as an Unna Boot) at baseline.
研究组 & 干预措施
Aggressive Debridement
Aggressive and frequent debridement of fibrin and crust from the wound base down to pinpoint bleeding, both by the patient as part of daily wound care at home, and also by the clinician (either physician or experienced dermatologic surgery nurse) during follow-up visits. Silver nitrate will be used to treat excessive granulation tissue only if the granulation tissue is higher than the level of surrounding skin. Patients will return weekly until healed. Patients will be provided with detailed instructions and guidelines to help determine whether healing has taken place.
干预措施: Debridement (Procedure)
Minimal Debridement
No debridement of fibrin by the patient or the clinician. Exceptions include debridement of dried crust or eschar. Silver nitrate will be used to treat excessive granulation tissue only if the granulation tissue is higher than the level of surrounding skin. Patients will return every two weeks until healed. In between visits at weekly intervals, the patient will be contacted by phone to determine if healing has occurred in between clinic visits11. Patients will be provided with detailed instructions and guidelines to help determine whether healing has taken place.
干预措施: Debridement (Procedure)
结局指标
主要结局
Time to healing
时间窗: 0-16 weeks
Time to complete healing as determined by one of the study investigators
次要结局
- Cosmetic Appearance(0-16 weeks. NOTE: A photograph of the the patient's final healed wound will be evaluated by a blinded investigator after the wound is determined to be completely healed by the study investigators; usually between 6-8 weeks)
- Number of required debridements(0-16 weeks)
- Patient satisfaction with scar: Patient Scar Assessment Questionnaire (PSAQ)(0-16 weeks. NOTE: The PSAQ will be completed by the patient once their wound is determined to be completely healed by the study investigators; usually between 6-8 weeks.)
- Number of treatment failures(Through study completion, an average of 6-8 weeks)
- Complications(0-16 weeks)
研究者
Jeffrey Tiger
Principal Investigator
Lahey Clinic