A Comparison of Polyglactin 910 and Chromic Gut Suture in the Closure of Punch Biopsy Sites
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 97
- 试验地点
- 2
- 主要终点
- Presence of Scarring
研究概览
简要总结
Some Dermatologists prefer absorbable suture to non-absorbable suture in the closure of punch biopsy sites. The reason these are often preferred is because patients do not have to pay for another visit to get the suture material removed. Also patients are not inconvenienced into returning to the office for suture removal1. However, the absorbable suture material currently used by most Dermatologists is very expensive.
In order to evaluate ways to reduce costs for patients, we will compare a less expensive suture material (chromic gut) with one of the absorbable suture materials currently used in clinical practice (PDS).
Patients who are eligible and choose to participate in the study will undergo a punch biopsy and a suture will be used to close the skin. The type of suture received by the patient will be randomized, like the flip of a coin. Group A will receive PDS and Group B will receive chromic gut suture.
After one weeks time, the patient will return to clinic and their dermatologist will evaluate the biopsy site for redness, wound infection, wound opening, and scar formation. The patients will be given a questionnaire evaluating their satisfaction with the cosmetic outcome and any pain caused by the suture materials. If the suture came out before the visit, the patient will be asked to report on what day the suture fell out. The patients will return two more times over the next two weeks to receive the same questionnaire and evaluation by their dermatologist.
详细描述
Purpose of the Study This study will seek to compare two absorbable suture materials (PDS and chromic gut) in the closure of punch biopsy sites. This information could contribute to cost savings and increased convenience for patients.
Background A punch biopsy is a full thickness skin biopsy performed by Dermatologists to diagnose various skin conditions. The incision from the biopsy ranges from 2 - 6mm in width2. There have been several recommendations of ways to manage these biopsy sites including the use of a non-absorbable suture such as nylon, healing by second intention and the use of an absorbable suture such as PDS or Polyglactin 9101,3. The benefit of an absorbable suture over a non-absorbable suture is reduced costs to the patient because they will not have pay for a suture removal visit. Also, the patients do not have the extra inconvenience of returning to the clinic a second time2,3. There has been only one case in the literature comparing an absorbable with a non-absorbable suture material in the closure of skin punch biopsy sites2. Never, has there been a study comparing two different absorbable suture in this setting. We believe there may be a less expensive suture material that would yield the same performance as the current ones. If this is the case, this information could benefit the Dermatology community in that it would provide a less expensive alternative suture material to close skin punch biopsy sites. Therefore, it would cut overall costs related to this routine procedure.
Chromic gut is an absorbable suture made from natural fibers of sheep or cattle intestine. It is one of the first absorbable sutures available and is inexpensive. The difference between plain gut and chromic gut is chromic gut is treated with chromic salts which allows it to retain its tensile strength longer. The suture integrity lasts 10-14 days (time at when the suture begins the absorption process) with complete absorption in 15-60 days. Chromic gut is documented to have moderate to high tissue reactivity4,5.
PDS is an absorbable, monofilament made from synthetic material (polyester). It is a newer, more expensive, absorbable suture material. The suture integrity lasts 45-60 days with total absorption in 180 days. PDS is documented to have low tissue reactivity and is shown to maintain its tensile strength in the presence of a bacterial infection4,5.
Performance of PDS with chromic gut suture in closing of punch biopsy sites would be compared in this study. We hope that the information that we collect could show that the less expensive suture (chromic gut) can be safely used in closing skin punch biopsy sites, therefore improving the clinical practice of these procedures and saving the health care system money.
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
- None
入排标准
- 年龄范围
- 18 Years 至 100 Years(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Be age 18 or older
- •Having a punch biopsy procedure performed for benign reasons
- •Biopsy site is between the shoulders and ankles
排除标准
- •Having a punch biopsy procedure performed for a suspicious cancerous lesion including basal and squamous cell carcinoma and melanoma
- •Biopsy site is on the face, palms, soles or groin area
结局指标
主要结局
Presence of Scarring
时间窗: 3 weeks
All subjects will be examined 1 week and 3 weeks after the wounds are closed with absorbable suture to assess the presence or absence of scarring. A scale of 0-1 was used (0=absent; 1=present).
次要结局
- Length of Time Till Absorbable Suture Fall Out(3 weeks)
- Presence of Infection(3 weeks)
研究者
Robert Brodell
Professor and Chief, Division of Dermatology
University of Mississippi Medical Center
