Absorbable subcuticular staples versus suture for caesarean section closure: a randomised clinical trial.

OBJECTIVE: To compare outcomes of efficiency, safety, patient, and surgeon satisfaction between absorbable subcuticular staples and subcuticular suture for caesarean section skin closure. DESIGN: A prospective, randomised, non-blinded, parallel-group trial. SETTING: Mayo Clinic Family Birth Center in Rochester, MN, USA. POPULATION: At least 18 years old and 24 weeks' gestation, undergoing caesarean section. Exclusion criteria were body mass index >50, chorioamnionitis, intrauterine fetal death, and multifetal gestation. METHODS: Patients were stratified by prior caesarean section, body mass index, and surgeon level and randomised to absorbable subcuticular staples or subcuticular suture. Electronic medical records and surveys were used. MAIN OUTCOME MEASURES: Primary outcomes were total operating time, from incision start to close. Secondary outcomes included subcuticular skin closure time, patient and surgeon satisfaction, percutaneous injuries, pain (analgesic use), cosmesis, and wound complications. RESULTS: Of 220 randomised patients, 206 were included in the final analysis (103 per group). Baseline characteristics were similar. The primary outcome of total operative time was not significantly different between groups [54.0 (44.9-63.6) versus 58.0 (50.4-68.2) minutes, P = 0.053]. The subcuticular staple group had shorter subcuticular skin closure time [median 2.6 (1.8-4.0) versus 8.5 (6.2-10.5) minutes, P < 0.001]. There were no differences in analgesic use, wound complications, cosmesis or patient satisfaction. One needlestick injury occurred with suture. Surgeons were more likely to recommend (97% versus 85%, P = 0.004) and use (98% versus 82%, P < 0.001) absorbable subcuticular staples. CONCLUSION: For caesarean section skin closure, absorbable subcuticular staples did not result in significantly different total operative times compared with sutures. Analgesic use, wound complications, and cosmesis were comparable. Patient and surgeon satisfaction were high with both methods. TWEETABLE ABSTRACT: Absorbable subcuticular staples associated with a similar total operative time compared with suture.

Zinc-based subcuticular absorbable staples: An in vivo and in vitro study.

A zinc-nutrient element alloy (Zn-1.0Cu-0.5Ca) was developed into subcuticular absorbable staples (SAS) as a robust alternative to the commercially available poly(l-lactide-co-glycolide) (PLGA) SAS for the first time. The fixation properties of the Zn SAS were measured via pull-out tests and in-situ lap-shear pull-out test comparatively against the PLGA SAS. The Zn SAS exhibited fixation force of 18.9±0.2 N, which was over three times higher than that of PLGA SAS (5.5±0.1 N). The Zn SAS was used to close incision wounds in a SD rat model for biodegradability and biocompatibility characterisation at 1, 4 and 12 weeks. The Zn SAS showed uniform degradation behaviour after in vivo implantation at the average rate of 198±54, 112±28, and 70±24 µm/y after 1, 4, and 12 weeks, which reduced the fixation force to 16.8±1.1 N, 15.4±0.9 N, 12.7±0.7 N, respectively. These findings showed the potential of the Zn SAS for the closure of heavy loading and slowing healing tissues. The Zn SAS enabled successful closure and healing of the incision wound, similar to the PLGA staples. However, the slow long-term degradation rate of the Zn SAS may lead to unnecessary implant retention. In addition, the alloy SAS resulted in higher local foreign body responses due to their stiffness. Reducing the implant cross-section profile and applying low stiffness and a corrosion-accelerating coating are suggested as possible approaches to reduce post-service implant retention and improve the biocompatibility of the Zn SAS. STATEMENT OF SIGNIFICANCE: This work reports the fabrication of the first metallic subcuticular absorbable staples (SAS) made from ZnCuCa alloy for skin wound closure applications. The Zn-based SAS were characterised in vitro and in vivo (SD rat model) for biodegradability, fixation properties, biocompatibility and inflammatory responses, which were compared against the commercially available PLGA-based SAS. The Zn-based SAS provided a secure attachment of the full-thickness wounds on SD rats and allowed successful healing during the 12-week service period. In addition, the in vitro results showed that the Zn-based SAS provided more than three times higher fixation strength than the commercial PLGA, indicating the potential of the Zn-based SAS for load-bearing wound closure application.