Negative pressure wound therapy versus usual care for Surgical Wounds Healing by Secondary Intention (SWHSI trial): study protocol for a randomised controlled pilot trial
Negative pressure wound therapy versus usual care for Surgical Wounds Healing by Secondary Intention (SWHSI trial): study protocol for a randomised controlled pilot trial
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DOI：
10.1186/s13063-016-1661-1
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发表时间：
2016-11-08
期刊：
影响因子：
2.5
通讯作者：
Chetter, Ian
中科院分区：
文献类型：
--
作者：
Arundel, Catherine;Buckley, Hannah;Chetter, Ian
背景：大多数手术后的切口通过缝合或夹子缝合伤口边缘而一期愈合。然而，一些伤口可能会裂开或从下向上愈合（即通过次要意图愈合）。手术伤口二期愈合（SWHSI）通常更复杂，需要在愈合过程中进行额外的治疗。关于这些复杂伤口的最佳治疗存在显著的不确定性，关于不同敷料和治疗的临床和成本效益的可靠证据有限;其中一种治疗是负压伤口治疗（NPWT），常用于SWHSI的管理。以前的随机对照试验（RCT）的NPWT未能招募到的时间和目标，因此，我们的目的是进行试点RCT，以评估进行未来的可行性，全面RCT.Methods：这试点RCT将测试的方法和可行性的招募，随机化，并保留参与者到一个更大的试验NPWT与SWHSI患者的日常护理。参与者将随机接受NPWT或常规护理（无NPWT），并将随访3 months.Discussion：本研究将提供一个全面的评估方法，和可行性，招募，随机，并保留SWHSI患者在试验NPWT与常规护理。在该试点试验的基础上，未来可能会提出一项完整的试验，该试验将为NPWT在SWHI管理中的临床和成本效益提供额外的有力证据。
Background: Most incisions following surgery heal by primary intention, with the edges of the wound apposed with sutures or clips. However, some wounds may break open or be left to heal from the bottom up (i.e. healing by secondary intention). Surgical Wounds Healing by Secondary Intention (SWHSI) are often more complex to manage, and require additional treatments during the course of healing. There is significant uncertainty regarding the best treatment for these complex wounds, with limited robust evidence regarding the clinical and cost-effectiveness of different dressings and treatments; one such treatment is Negative Pressure Wound Therapy (NPWT) which is frequently used in the management of SWHSI. Previous randomised controlled trials (RCTs) of NPWT have failed to recruit to time and target, thus we aimed to conduct a pilot RCT to assess the feasibility of conducting a future, full-scale RCT.Methods: This pilot RCT will test the methods and feasibility of recruiting, randomising, and retaining participants into a larger trial of NPWT verses usual care for patients with SWHSI. Participants will be randomised to receive either NPWT or usual care (no NPWT) and will be followed up for 3 months.Discussion: This study will provide a full assessment of methods for, and feasibility of, recruiting, randomising, and retaining patients with SWHSI in a trial of NPWT versus usual care. On the basis of this pilot trial, a full trial may be proposed in the future which will provide additional, robust evidence on the clinical and cost-effectiveness of NPWT in the management of SWHSI.