scholarly journals A Randomized Controlled Trial of Running Versus Interrupted Subcuticular Sutures for Skin Closure in Open Gastric Surgery

2018 ◽  
Vol 103 (5-6) ◽  
pp. 305-314
Author(s):  
Kentaro Inoue ◽  
Taku Michiura ◽  
Junichi Fukui ◽  
Hiromi Mukaide ◽  
Takashi Ozaki ◽  
...  
Keyword(s):  
Controlled Trial ◽  
Performance Status ◽  
Gastrointestinal Surgery ◽  
Distant Metastases ◽  
Final Decision ◽  
Skin Closure ◽  
Time Saving ◽  
Subcuticular Suture ◽  
Scar Assessment ◽  
Significant Difference

Objective: The aim of this study was to compare the scar quality associated with different types of subcuticular suture techniques: running or interrupted. Summary of Background Data: Subcuticular suture is a preferred skin closure method even in gastrointestinal surgery. Two methods for subcuticular suture are used: running or interrupted sutures. Methods: Inclusion criteria were as follows: age ≥ 20 years; American Society of Anesthesiologists performance status 1 to 3; histologically proven adenocarcinoma of the stomach; no evidence of distant metastases or disease considered unresectable; no prior upper abdominal surgery; no uncontrolled infections, diabetes, or cardiac disease; and adequate renal function. Patients were randomly assigned to running subcuticular suture or interrupted subcuticular suture. Scar areas were calculated using a digital photograph calculator at about 7 months after surgery. The observer scar assessment scale (OSAS) was used for scar assessment. Results: Between April 10, 2009, and February 28, 2012, 220 patients were enrolled into this study and 201 patients were evaluated. There was no difference in scar area between the interrupted group and the running group [0.97 cm2 (95% CI: 0.73–1.21) in the interrupted group and 1.17 cm2 (95% CI: 0.91–1.42, P = 0.27) in the running group]. Three observers performed the OSAS, for which no significant difference was detected across the closure groups. Conclusions: There were no significant differences in cosmetic outcomes between running and interrupted subcuticular sutures. The final decision about the choice of method should be made balancing surgeon needs (time-saving with running) and surgeon techniques (running might be difficult).

Combination chemotherapy versus single-agent therapy as first- and second-line treatment in metastatic breast cancer: a prospective randomized trial.

1998 ◽  
Vol 16 (12) ◽  
pp. 3720-3730 ◽  
Author(s):  
H Joensuu ◽  
K Holli ◽  
M Heikkinen ◽  
E Suonio ◽  
A R Aro ◽  
...  
Keyword(s):  
Breast Cancer ◽  
Combination Chemotherapy ◽  
Performance Status ◽  
Single Agent ◽  
Objective Response ◽  
Metastatic Breast ◽  
Distant Metastases ◽  
World Health ◽  
Second Line ◽  
Significant Difference

PURPOSE We report results of a randomized prospective study that compared single agents of low toxicity given both as the first-line and second-line chemotherapy with combination chemotherapy in advanced breast cancer with distant metastases. PATIENTS AND METHODS Patients in the single-agent arm (n = 153) received weekly epirubicin (E) 20 mg/m2 until progression or until the cumulative dose of 1,000 mg/m2, followed by mitomycin (M) 8 mg/m2 every 4 weeks, and those in the combination chemotherapy arm (n = 150) were first given cyclophosphamide 500 mg/m2, E 60 mg/m2, and fluorouracil 500 mg/m2 three times per week (CEF) followed by M 8 mg/m2 plus vinblastine (V) 6 mg/m2 every 4 weeks. Exclusion criteria included age greater than 70 years, World Health Organization (WHO) performance status greater than 2, prior chemotherapy for metastatic disease, and presence of liver metastases in patients younger than 50. RESULTS An objective response (complete [CR] or partial [PR]) was obtained in 55%, 48%, 16%, and 7% of patients treated with CEF, E, M, and MV, respectively. A response to CEF tended to last longer than a response to E (median, 12 v 10.5 months; P = .07). Treatment-related toxicity was less in the single-agent arm and quality-of-life (QOL) analysis favored the single-agent arm. No significant difference in time to progression or survival was found between the two arms. Similarly, no difference in survival was found when the patients who received both the planned first-and second-line treatments were compared or when survival was calculated from the beginning of the second-line therapy. CONCLUSION Patients treated with single-agent E followed by single-agent M had similar survival, but less treatment-related toxicity and better QOL as compared with those treated with CEF followed by MV.

A randomised controlled trial of absorbable versus non-absorbable sutures for skin closure after open carpal tunnel release

2011 ◽  
Vol 37 (4) ◽  
pp. 350-353 ◽  
Author(s):  
C. Theopold ◽  
S. Potter ◽  
M. Dempsey ◽  
M. O’Shaughnessy
Keyword(s):  
Carpal Tunnel ◽  
Controlled Trial ◽  
Carpal Tunnel Release ◽  
Cost Savings ◽  
Study Groups ◽  
Skin Closure ◽  
Absorbable Sutures ◽  
Scar Assessment ◽  
Scale Scores ◽  
Randomised Controlled

We compared the aesthetic outcome of scars after closure of open carpal tunnel incisions with either absorbable 4-0 Vicryl Rapide or non-absorbable 4-0 Novafil. Patients were recruited in a randomized controlled trial and scars were scored at 6 weeks using a modified Patient and Observer Scar Assessment Scale. Scores demonstrated differences only for pain, vascularity and cross-hatching between both groups, though none of these were statistically significant. The dissolving and falling out of Vicryl Rapide was significantly more comfortable than removal of 4-0 Novafil sutures, assessed on a numerical analogue scale. There was no difference in infection rate between both study groups, supporting overall the use of Vicryl Rapide for the closure of palmar hand incisions, in light of the convenience and cost savings associated with absorbable sutures.

A phase III study of Æ-941 with induction chemotherapy (IC) and concomitant chemoradiotherapy (CRT) for stage III non- small cell lung cancer (NSCLC) (NCI T99–0046, RTOG 02–70, MDA 99–303)

2007 ◽  
Vol 25 (18_suppl) ◽  
pp. 7527-7527 ◽  
Author(s):  
C. Lu ◽  
J. J. Lee ◽  
R. Komaki ◽  
R. S. Herbst ◽  
W. K. Evans ◽  
...  
Keyword(s):  
Controlled Trial ◽  
Performance Status ◽  
Stage Iiib ◽  
Phase Iii ◽  
Stage Iii ◽  
Type I ◽  
Eligibility Criteria ◽  
Unresectable Stage ◽  
Significant Difference ◽  
Stage Iii Nsclc

7527 Background: Æ-941 is a shark cartilage extract with antiangiogenic properties. We conducted a placebo-controlled trial testing Æ-941, with IC and CRT, in unresectable stage III NSCLC. Methods: Eligibility criteria included performance status (PS) < 2, weight loss < 10%. Subjects received one of two treatment regimens depending on site of enrollment: carboplatin (C) (AUC 6) and paclitaxel (P) (200 mg/m2) × 2 cycles followed by CRT (60 Gy/30 fractions) with weekly C (AUC 2) and P (45 mg/m2) × 6 doses or cisplatin (CDDP) (75 mg/m2, d1) and vinorelbine (V) (30 mg/m2, d1 and 8) × 2 cycles followed by CRT (60 Gy/30 fractions) with CDDP (75 mg/m2, day 1) and V (15 mg/m2, d1 and 8) × 2 cycles. Subjects were randomized to receive Æ-941 (Arm A) or placebo (Arm B), 120 mL orally twice daily, at the start of IC and continuing after CRT as maintenance therapy. Randomization was stratified for stage, gender, and type of chemotherapy. The primary endpoint was overall survival (OS), with a planned sample size of 756 subjects providing 80% power to detect a 25% difference in OS, assuming a control arm median survival time (MST) of 13 months, type I error 0.05. Results: Between 6/00 and 2/06, 384 subjects were enrolled onto the trial and randomized. In 2/06 the trial was closed to new patient entry due to insufficient accrual. This final analysis is based on 379 randomized and eligible subjects (188 arm A, 191 arm B). Subject characteristics: 60% male, median age 63 years (range 37–84), 56% stage IIIB, 58% C-based chemotherapy, median follow-up 3.7 years. There was no significant difference in OS between arms A and B, with MSTs of 14.4 (95% CI 12.6–17.9) and 15.6 (95% CI 13.8–18.1) months, respectively (log-rank p=0.73). OS by pre-specified stratification factors: stage IIIB vs IIIA (MST 13.9 vs. 17.4 months, p=0.25), C vs. CDDP chemotherapy (MST 14.4 vs. 16.7 months, p=0.13), and male vs. female (MST 15.7 vs. 15.1 months, p=0.74). The study drug was well tolerated. Fewer subjects in arm A experienced grade 3 or higher adverse events (66% vs. 77%, p=0.018). Conclusions: The addition of Æ−941 to IC and CRT does not improve OS in patients with unresectable stage III NSCLC. No significant financial relationships to disclose.

A multicenter, randomized, double-blinded, placebo-controlled trial of modafinil for lung cancer-related fatigue: Dose response and patient satisfaction data.

2013 ◽  
Vol 31 (15_suppl) ◽  
pp. 9503-9503 ◽  
Author(s):  
Kate Fife ◽  
Anna Spathis ◽  
Susan J. Dutton ◽  
Fiona Helen Blackhall ◽  
Ronja Bahadori ◽  
...  
Keyword(s):  
Lung Cancer ◽  
Patient Satisfaction ◽  
Dose Response ◽  
Controlled Trial ◽  
Performance Status ◽  
Locally Advanced ◽  
Ecog Performance Status ◽  
Nccn Guidelines ◽  
Fatigue Score ◽  
Significant Difference

9503 Background: Fatigue is a very common, disabling symptom in cancer, and particularly severe in lung cancer. Modafinil is a novel central nervous system stimulant, which, along with methylphenidate, is cautiously recommended by the 2013 National Comprehensive Cancer Network Guidelines for fatigue. In this phase IV randomized placebo-controlled trial, we assessed the efficacy of modafinil for managing fatigue in lung cancer. Methods: Adults with locally advanced or metastatic non small cell lung cancer (stages III and IV), ECOG performance status (PS) 0-2 and suffering from fatigue (score 5/10 or greater) were randomised 1:1 to modafinil or matched placebo, 100mg daily for 14 days and 200mg daily for a further 14 days. The primary outcome measure was change in the Functional Assessment of Chronic Illness Therapy fatigue subscale (FACIT-fatigue) at 28 days. The trial was powered to detect a 5-point difference with 80% power and 5% significance allowing for 25% attrition. Dose-response, patient satisfaction and safety were also evaluated. Results: 208 patients were recruited from 24 UK centres. Baseline characteristics were well-balanced. 160 patients completed both baseline and 28 day questionnaires and were included in the modified-ITT analysis. FACIT-fatigue mean change from baseline was modafinil=5.28, placebo=5.11, difference=0.17, (95%CI -4.17, 3.82). Adjustment for baseline fatigue and PS had no impact on outcome. No dose response was seen; the majority of improvement on all scales was seen at 14 days and sustained to 28 days. 47% of the modafinil group and 23% of the placebo group stated the study treatment was not helpful (p=0.132). Adverse events were equal. Conclusions: Both modafinil and placebo led to a clinically significant 5-point improvement in FACIT-fatigue score, but there was no significant difference between the two groups. This well-powered study suggests that there is a large placebo effect and NCCN guidelines should be reviewed. Clinical trial information: NCT00829322. [Table: see text]

scholarly journals A Randomized Study Comparing Skin Staples with Subcuticular Sutures for Wound Closure at Caesarean Section in Black-Skinned Women

2014 ◽  
Vol 2014 ◽  
pp. 1-8 ◽  
Author(s):  
Rukiyat Adeola Abdus-Salam ◽  
Folasade Adenike Bello ◽  
Oladapo Olayemi
Keyword(s):  
Caesarean Section ◽  
Wound Closure ◽  
Operation Time ◽  
Skin Closure ◽  
Subcuticular Suture ◽  
Wound Closure Techniques ◽  
Patients Satisfaction ◽  
Skin Staples ◽  
Scar Assessment ◽  
Suture Group

This study aimed to compare patients’ satisfaction and outcome of caesarean section wound closure by skin staples and subcuticular suture at discharge and 6 weeks of postoperation. It was a randomized controlled trial of pregnant women scheduled for caesarean section at the University College Hospital, Ibadan, Nigeria, allocating them to wound closure by skin staples or subcuticular suture. Pain was assessed using the box numeric pain scale. Scar assessments were by patient, research nurse, and independent observers using the visual analogue scale, modified patient observer scar assessment scale, and patient satisfaction scale. Operation time (minutes) was significantly shorter in the staple group, 40.26 (±16.53) compared to 47.55 (±14.55) in the suture group (P=0.025). Skin closure time (seconds) was significantly less in the staple group, 118.62 (±69.68) versus 388.70 (±170.40) in the suture group (P≤0.001). There was no difference in pain experienced, wound assessment by the participants, and patients’ satisfaction. Participants in the staple group scored higher on both scar assessment scales by the nurse (P=0.044). Cost comparison analysis showed that staple use costs significantly more than suture use (P<0.001). The perceived benefit of subcuticular suture over skin staples was not observed and participants were satisfied with both wound closure techniques.

Randomized controlled trial of wound complication rates of subcuticular suture vs staples for skin closure at cesarean delivery

2010 ◽  
Vol 203 (3) ◽  
pp. 285.e1-285.e8 ◽  
Author(s):  
Suzanne L. Basha ◽  
Meredith L. Rochon ◽  
Joanne N. Quiñones ◽  
Kara M. Coassolo ◽  
Orion A. Rust ◽  
...  
Keyword(s):  
Randomized Controlled Trial ◽  
Cesarean Delivery ◽  
Controlled Trial ◽  
Wound Complication ◽  
Skin Closure ◽  
Complication Rates ◽  
Subcuticular Suture ◽  
Randomized Controlled

Cosmetic Outcome of Wound Closure between Steri-Strips (3M™ Steri-Strip) and Simple Interrupted Nylon 6-0 Sutures in Out-Patient Cervical Lymph Node Excision: A Randomized Controlled Trial

2021 ◽  
Vol 104 (7) ◽  
pp. 1088-1094
Keyword(s):  
Randomized Controlled Trial ◽  
Lymph Node ◽  
Cervical Lymph Node ◽  
Controlled Trial ◽  
Nylon 6 ◽  
Lymph Node Excision ◽  
Skin Closure ◽  
Randomized Controlled ◽  
Significant Difference ◽  
The Aesthetic

Objective: To compare the aesthetic outcome of cervical lymph node excision skin closure between Steri-Strips closure and simple interrupted sutures using Nylon 6-0. Materials and Methods: The present study was a single-blinded randomized controlled trial of forty patients with cervical lymph node excision. They were randomized into two groups of twenty. The first group was allocated to close the skin by simple interrupted sutures with Nylon 6-0, the other group received the Steri-Strips for skin closure. Complications were observed at the first and second week. The aesthetic outcomes for skin closure were evaluated at 12 weeks postoperatively using the predetermined Sakka’s cosmetic assessment criteria and scoring system. Results: There was no statistically significant difference between the two groups in terms of gender, age, length of surgical wound, and pathology. The Steri-Strips group showed significantly lower Sakka’s aesthetic score compared to the 6-0 Nylon sutures group (6.25±0.85 and 7.75 ±1.33, p<0.001). There was no significant difference in aesthetic outcomes between genders. Moreover, the operative time of the Steri-Strips group was significantly less than that of the 6-0 Nylon sutures group (2.2±0.41 and 4.75±0.44 minutes, p<0.001). Conclusion: Skin closure with Steri-Strips gave better aesthetic outcomes compared to the 6-0 Nylon sutures (p<0.001). However, the aesthetic outcomes were assessed by physicians, so the patients’satisfaction could not be assessed. Keywords: Lymph node biopsy; Hypertrophic scar; Keloid; Cosmetic outcome; Steri-strip

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