Wagener Jenny, Shan Usha, Anderson William F, Mason Isaac T T, May Barnaby C H, Locke Michelle B
From the Middlemore Hospital, Te Whatu Ora Counties Manukau, Auckland, New Zealand.
Whangarei Hospital, Te Whatu Ora - Te Tai Tokerau, Whangarei, New Zealand.
Plast Reconstr Surg Glob Open. 2025 Aug 25;13(8):e7027. doi: 10.1097/GOX.0000000000007027. eCollection 2025 Aug.
Surgery resulting in tissue removal and the formation of dead space is traditionally managed with surgical drains. Drains are used to reduce fluid accumulation and decrease the risk of infection, dehiscence, and seroma formation. However, drains do not actively appose adjacent tissue planes to address dead space. A first-in-human clinical study was undertaken following simple unilateral mastectomy using a novel tissue apposition device.
This prospective pilot study collected data on 10 participants undergoing simple unilateral mastectomy who would otherwise have received standard surgical drains as part of postoperative management. Participants were instead managed with a pulsed air closure technology (PACT) device designed to remove fluid and to appose adjacent tissue planes of the excisional site. Participants were monitored for complications, fluid output, and fluid accumulation, with a 3-month follow-up.
The mean tissue excised was 793.7 ± 353.9 g. The PACT device removed a mean cumulative fluid volume of 306.2 ± 163.7 mL during a mean treatment duration of 6.5 ± 1.5 days. Ultrasound assessment, at approximately 14 days postoperatively, estimated a median fluid accumulation of 6.9 mL (interquartile range: 0.0-66.2 mL) at the treatment site. Minor complications included exit site bruising, erythema before drainage catheter removal, and a single resolving superficial infection. Only 1 participant developed a seroma requiring clinical intervention.
The PACT device performed its intended function in simple unilateral mastectomies. Minor complications were similar to those observed with traditional surgical drains and all resolved by the 3-month follow-up. These findings warrant further investigation in larger cohorts and in additional surgical applications.
导致组织切除并形成死腔的手术传统上通过手术引流管来处理。引流管用于减少液体蓄积，并降低感染、切口裂开和血清肿形成的风险。然而，引流管并不能主动使相邻组织平面贴合以消除死腔。一项针对首例人体的临床研究在单纯性单侧乳房切除术后使用了一种新型组织贴合装置。
这项前瞻性试点研究收集了10名接受单纯性单侧乳房切除术患者的数据，这些患者若接受标准术后管理本应使用传统手术引流管。取而代之的是，这些患者使用一种脉冲空气闭合技术（PACT）装置进行管理，该装置旨在排出液体并使切除部位的相邻组织平面贴合。对患者进行并发症、液体排出量和液体蓄积情况的监测，并进行3个月的随访。
平均切除组织量为793.7±353.9克。在平均治疗时长6.5±1.5天内，PACT装置排出的平均累积液体量为306.2±163.7毫升。术后约14天的超声评估估计，治疗部位的液体蓄积中位数为6.9毫升（四分位间距：0.0 - 66.2毫升）。轻微并发症包括引流管出口处瘀斑、拔除引流导管前的红斑以及一例自行消退的浅表感染。只有1名患者出现了需要临床干预的血清肿。
PACT装置在单纯性单侧乳房切除术中发挥了预期功能。轻微并发症与传统手术引流管观察到的并发症相似，且在3个月随访时均已解决。这些发现值得在更大规模队列和更多手术应用中进一步研究。
