Wound healing after craniotomy: a randomized trial comparing scalp clips to artery forceps for scalp hemostasis

Object In this prospective randomized clinical trial, investigators looked at wound healing after craniotomy. The hypothesis was that the self-closing plastic scalp clips used for hemostasis on the skin edge might lead to localized microscopic tissue damage and subsequent delayed wound healing. Methods The trial consisted of 2 arms in which different methods were used to secure scalp hemostasis: 1) the routinely used plastic clips (Scalpfix, Aesculap); and 2) the older method of artery forceps placed on the galea. Participants were restricted to those > 16 years of age undergoing craniotomies expected to last > 2 hours. Repeat operations were not included. One hundred fifty patients were enrolled. They were visited at 3 and 6 weeks postoperatively by an observer blinded to the method used, and the wounds were assessed for macroscopic epithelial closure, signs of infection, and hair regrowth by using a predefined assessment scale. Results The results showed no significant difference in wound healing between the 2 groups at either 3 weeks (OR 0.55, 95% CI 0.27–1.11; p = 0.09) or 6 weeks (OR 0.79, 95% CI 0.39–1.58; p = 0.50). The length of operation was found to be a significant factor affecting wound healing at 6 weeks (OR/hour 0.68, 95% CI 0.51–0.92; p = 0.01). Conclusions The use of Aesculap Scalpfix self-retaining plastic scalp clips on the skin edge during craniotomy surgery does not appear to affect wound healing significantly to the postoperative 6-week mark.

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Pengaruh Luka Iris Pada Tikus Dengan Paparan Hidrogen Peroxida 3% terhadap Epitelisasi dan Pembentukan Eksudat pada Permukaan Epitel Kulit.

Hang Tuah Medical journal ◽

10.30649/htmj.v17i2.438 ◽

2020 ◽

Vol 17 (2) ◽

pp. 172

Author(s):

HARMAN AGUSAPUTRA ◽

MARIA SUGENG ◽

AYLY SOEKAMTO ◽

ATIK WULANDARI

Keyword(s):

Hydrogen Peroxide ◽

Wound Healing ◽

The Other ◽

Delayed Wound Healing ◽

Peroxide Group ◽

Hemostatic Effect ◽

Significant Difference ◽

Negative Effect ◽

Wound Healing Effect ◽

Epithelial Growth

AbstractBackground: Hydrogen peroxide (H2O2) as antiseptic has been used frequently to clean woundsin in hospitals and clinics. Hydrogen peroxide has the effectof strong oxidative that can kill pathogens. It can clean up debris and necrotic tissuesin wounds. Hydrogen peroxidealso has hemostatic effect that can help to stop bleeding. Besides antiseptic effects, hydrogen peroxide i s suspected of having negative effect in wound healing. Hydrogen peroxide presumably could cause delayed wound healing by exudate formation and delayed epithelial growth.Method: This study was conducted in the laboratory using 48 white mice that were divided into 2 groups. All the mice were purposely wounded. Afterwards in one group the wounds were clean up using hydrogen peroxide, while in the other group without hydrogen peroxide as control. The wounds of both groups were observed on day 1, day 3 and day 7. On day 1 and day 3, both groups did not show significant difference.Result : on day 7 showed that the wound healing in hydrogen peroxide group were delayed. Fifty percent of them had the formation of exudate and 62.5% of them showed delayed epithelial growth.Conclusion : This study could show hydrogen peroxide as wound antiseptic has delayed wound healing effect.Keyword: hydrogen peroxide, wound healing

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Neoadjuvant chemotherapy in high-risk soft tissue sarcomas: Final results of a randomized clinical trial from the Italian Sarcoma Group, the Spanish Sarcoma Group (GEIS), the French Sarcoma Group (FSG), and the Polish Sarcoma Group (PSG).

Journal of Clinical Oncology ◽

10.1200/jco.2019.37.15_suppl.11000 ◽

2019 ◽

Vol 37 (15_suppl) ◽

pp. 11000-11000 ◽

Cited By ~ 1

Author(s):

Alessandro Gronchi ◽

Emanuela Palmerini ◽

Vittorio Quagliuolo ◽

Javier Martin Broto ◽

Antonio Lopez Pousa ◽

...

Keyword(s):

Clinical Trial ◽

High Risk ◽

Neoadjuvant Chemotherapy ◽

Randomized Trial ◽

Soft Tissue Sarcomas ◽

Final Analysis ◽

Myxoid Liposarcoma ◽

High Dose ◽

Peripheral Nerve Sheath Tumors ◽

Significant Difference

11000 Background: A ISG randomized trial on 5 cycles of adjuvant epirubicin+ifosfamide (EI) versus no chemotherapy suggested an OS benefit in localized high-risk STS (JCO 2001;19:1238). A subsequent trial showed no difference between 3 vs 5 cycles of the same neoadjuvant regimen (JCO 2012;30:850). The aim of this trial was to compare 3 cycles of EI versus a histology-tailored (HT) neoadjuvant regimen in selected localized high-risk STS. Methods: This is a multicenter European randomized trial comparing EI versus a HT regimen: gemcitabine+docetaxel in undifferentiated pleomorphic sarcoma (UPS); trabectedin in high-grade myxoid liposarcoma; high-dose prolonged-infusion ifosfamide in synovial sarcoma (SS); etoposide+ifosfamide in malignant peripheral nerve sheath tumors (MPNST); gemcitabine+dacarbazine in leiomyosarcoma (LMS). Patients had localized high-risk (grade = 3; size ≥5 cm) STS of extremities or trunk wall. Primary end-point was Disease Free Survival (DFS). The final analysis was planned after the observation of 130 events. This allows an 80% power to detect a significant difference at the 5% 2-sided level, if the true HR is 0.6 in favor of EI, as shown by the interim analysis (Lancet Oncol 2017;18:812-822). Results: From May 2011 to May 2016, 287 patients were randomized (97 = UPS; 65 = myxoid liposarcoma; 70 = SS; 27 = MPNST; 28 = LMS). The median follow-up was 51.75 months for the alive patients (IQ 28.03) The DFS and OS probability at 60 months were 0.48 and 0.55 (HR:1.232; 95%CI: 0.875-1.733; log rank p=0.323) and 0.66 and 0.76 (HR:1.766; 95%CI:1.101-2.831; log rank p=0.018), in the HT and EI arm, respectively. Conclusions: The final analysis shows a non-statistically significant DFS difference in favor of EI over HT chemotherapy with a larger and statistically significant OS difference. The outcome of patients on EI overlapped previous ISG trials. EI should remain the regimen of choice when neoadjuvant chemotherapy is used in high-risk localized STS. However this trial cannot be used as a formal proof of efficacy of (neo)adjuvant chemotherapy per se. EUDRACT 2010 – 023484 – 17. Funding source: Eurosarc FP7 278472. Clinical trial information: NCT01710176.

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A Multicenter Randomized Double-blind Controlled Clinical Trial of Fiber Post Cementation Strategies

Operative Dentistry ◽

10.2341/16-278-c ◽

2018 ◽

Vol 43 (2) ◽

pp. 128-135 ◽

Cited By ~ 4

Author(s):

CD Bergoli ◽

LP Brondani ◽

VF Wandscher ◽

GKR Pereira ◽

MS Cenci ◽

...

Keyword(s):

Clinical Trial ◽

Survival Rate ◽

Glass Fiber ◽

Survival Rates ◽

The Self ◽

Controlled Clinical Trial ◽

Fiber Post ◽

Resin Cements ◽

Double Blind ◽

Significant Difference

SUMMARY Objectives: The aim of this prospective randomized multicenter clinical trial was to evaluate the survival rate of glass fiber–reinforced posts cemented with self-adhesive or regular resin cements. Methods: The sample was comprised of 152 teeth randomized within two centers and in accordance with the adhesive strategies for RelyX U100/U200 (3M ESPE) or Single Bond and RelyX ARC (3M ESPE). The cementation procedures were standardized and performed by previously trained operators. The primary outcome evaluated was post debonding. A trained evaluator, one for each center, assessed all subjects at intervals of 12 months for up to 6 years. Statistical analysis was performed using the Kaplan-Meier method. Results: There was no statistically significant difference in survival rates between the two strategies assessed (p=0.991), with a 92.7% survival rate for the self-adhesive cement and 93.8% for the regular cement. Conclusion: Both the self-adhesive and the regular resin cements are good alternatives for glass fiber post cementation.

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Evaluation of the effect of Teucrium polium ointment on the episiotomy wound healing in primiparous women

Immunopathologia Persa ◽

10.34172/ipp.2021.33 ◽

2021 ◽

Vol 7 (2) ◽

pp. e33-e33

Author(s):

Atena Mohammady Rouzbahani ◽

Mahrokh Dolatian ◽

Tayebeh Jahedbozorgan ◽

Faraz Mojab ◽

Majid Tajik

Keyword(s):

Clinical Trial ◽

Wound Healing ◽

Surgical Incision ◽

Second Stage Of Labor ◽

Second Stage ◽

Significant Difference ◽

Teucrium Polium ◽

The Mean ◽

First Time ◽

Primiparous Women

Introduction: Episiotomy is a surgical incision at the vaginal opening performed in the second stage of labor during childbirth. The purpose of performing an episiotomy is to increase the size of the soft tissue of the pelvis floor and prevent damage to the perineum, facilitate delivery, and reduce the time during childbirth. Objectives: This study aimed to determine the effect of Teucriumpolium ointment on wound healing in primiparous women. Patients and Methods: This triple-blinded clinical trial was conducted on 84 primiparous women referred to Mahdieh hospital in Tehran. Participants randomly received 2% T. polium ointment and placebo. The first time the ointment was started 24 hours after delivery and continued twice a day for 10 days. Wound healing rate was measured by redness, edema, ecchymosis, discharge, and approximation (REEDA) scale on days 1, 5, and 10 postpartum. The data were analyzed using SPSS version 23. Results: The results were performed on 84 women, 43 people using T. polium ointment and 41 people using placebo ointment. There was no significant difference between the two groups regarding obstetrics and demographic characteristics at the beginning of the study. The mean scores of REEDA in the T. polium group in the first 12 hours, days 5 and 10 were significantly different from the placebo group (P<0.001). Conclusion: Wound healing following episiotomy can be accelerated due to antibacterial, anti-inflammatory, and antiseptic properties of T. polium ointment. Trial Registration: The trial protocol was approved by the Iranian registry of clinical trial (#IRCT20100130003226N18; https://en.irct.ir/trial/40004, ethical code# IR.SBMU.RETECH.1398.055).

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Failure Rates of Orthodontic Fixed Lingual Retainers bonded with Two Flowable Light-cured Adhesives: A Comparative Prospective Clinical Trial

The Journal of Contemporary Dental Practice ◽

10.5005/jp-journals-10024-1902 ◽

2016 ◽

Vol 17 (8) ◽

pp. 630-634 ◽

Cited By ~ 1

Author(s):

Nabeel F Talic

Keyword(s):

Clinical Trial ◽

Odds Ratio ◽

Prospective Clinical Trial ◽

Failure Rates ◽

Survival Times ◽

Prospective Randomized Clinical Trial ◽

Low Viscosity ◽

Significant Difference ◽

Flowable Composites

ABSTRACT Introduction This comparative prospective randomized clinical trial examined the in vivo failure rates of fixed mandibular and maxillary lingual retainers bonded with two light-cured flowable composites over 6 months. Materials and methods Consecutive patients were divided into two groups on a 1:1 basis. Two hundred fixed lingual retainers were included, and their failures were followed for 6 months. One group (n = 50) received retainers bonded with a nano-hybrid composite based on nano-optimized technology (Tetric-N-Flow, Ivoclar Vivadent). Another group (n = 50) received retainers bonded with a low viscosity (LV) composite (Transbond Supreme LV, 3M Unitek). Results There was no significant difference between the overall failure rates of mandibular retainers bonded with Transbond (8%) and those bonded with Tetric-N-Flow (18%). However, the odds ratio for failure using Tetric-N-flow was 2.52-fold greater than that of Transbond. The failure rate of maxillary retainers bonded with Transbond was higher (14%), but not significantly different, than that of maxillary retainers bonded with Tetric- N-flow (10%). There was no significant difference in the estimated mean survival times of the maxillary and mandibular retainers bonded with the two composites. Conclusion Both types of composites tested in the current study can be used to bond fixed maxillary and mandibular lingual retainers, with low failure rates. How to cite this article Talic NF. Failure Rates of Orthodontic Fixed Lingual Retainers bonded with Two Flowable Light-cured Adhesives: A Comparative Prospective Clinical Trial. J Contemp Dent Pract 2016;17(8):630-634.

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Fish skin grafts compared to human amnion/chorion membrane allografts: A double‐blind, prospective, randomized clinical trial of acute wound healing

Wound Repair and Regeneration ◽

10.1111/wrr.12761 ◽

2019 ◽

Vol 28 (1) ◽

pp. 75-80 ◽

Cited By ~ 1

Author(s):

Robert S. Kirsner ◽

David J. Margolis ◽

Baldur T. Baldursson ◽

Kristin Petursdottir ◽

Olafur B. Davidsson ◽

...

Keyword(s):

Clinical Trial ◽

Wound Healing ◽

Randomized Clinical Trial ◽

Skin Grafts ◽

Fish Skin ◽

Double Blind ◽

Human Amnion ◽

Prospective Randomized Clinical Trial ◽

Acute Wound

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Anterior Incision Offloading for Primary and Revision Total Ankle Replacement: A Comparative Analysis of Two Techniques

The Open Orthopaedics Journal ◽

10.2174/1874325001711010678 ◽

2017 ◽

Vol 11 (1) ◽

pp. 678-686 ◽

Cited By ~ 2

Author(s):

Andrew D. Elliott ◽

Thomas S. Roukis

Keyword(s):

Wound Healing ◽

Total Ankle Replacement ◽

Wound Complications ◽

Comparison Study ◽

Delayed Wound Healing ◽

Replacement Surgery ◽

Ankle Replacement ◽

Significant Difference ◽

Incision Wound ◽

Anterior Incision

Background: There exists a high risk of post-operative complications with primary and revision total ankle replacement surgery. Delayed wound healing of the anterior incision is common. The reason for this is multi-factorial and, to date, most of the research has focused on predisposing factors involving the patients themselves. Only recently have researchers begun to look at the post-operative dressing as a possible consideration when trying to prevent incision wound healing complications. Currently, no standard post-operative dressing for primary or revision total ankle replacement exists. However, the principles of post-operative edema reduction to improve healing, as advocated by Sir Robert Jones and demonstrated in his compressive dressing, have been known for decades. We have been using a modified Sir Robert Jones compressive dressing for both primary and revision total ankle replacements. Recently, we have added an aperture pad made of cotton cast padding over the anterior incision in order to protect the area from pressure necrosis. Methods: This is a comparison study of the post-operative wound complications involving 35 patients that received the original dressing and 33 patients that received the addition of the aperture pad. Results: With no significant difference in the patient populations, the results demonstrate a 3-fold decrease in the number of anterior incision wound healing complications with the use of the aperture pad. Conclusion: This dressing represents a simple, reproducible, easy to apply and inexpensive way to prevent post-operative edema and anterior incision wound healing complications.

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Use of a Negative-Pressure Wound Dressing to Prevent Surgical Site Complications after Revision Knee Arthroplasty—A Randomized Controlled Trial

Applied Sciences ◽

10.3390/app11199102 ◽

2021 ◽

Vol 11 (19) ◽

pp. 9102

Author(s):

Christoph Deborre ◽

Afoma Ezissi ◽

Max Jaenisch ◽

Mona Khoury ◽

Christof Burger ◽

...

Keyword(s):

Wound Healing ◽

Knee Arthroplasty ◽

Negative Pressure ◽

Wound Dressing ◽

Controlled Trial ◽

Test Group ◽

Control Group ◽

Duration Of Treatment ◽

Delayed Wound Healing ◽

Significant Difference

The aim of this study was to determine if a negative pressure wound therapy (NPWT) system can facilitate wound healing and withstand mechanical stress owing to the high range of motion of the knee joint in total knee arthroplasty. The benefits of NPWT include aiding wound granulation and a reduction in wound edema and secretion; our goal is to investigate its benefits in primary wound closure. Within an eight-day duration of treatment, we compared standard wound dressing (gauze and compression) with the disposable NPWT system (PICO)TM. A total of 79 patients were recruited in a controlled, randomized, prospective, single-institution clinical trial. A total of 40 patients were allocated to the study group and 39 to the control group. In terms of blood loss and infection parameters, there was no significant difference between both groups. In the NPWT group, we determined a significant reduction in wound edema but none in wound secretion. While the NPWT dressings survived the mechanical effects of movement during postoperative physiotherapy, conventional compressive dressings were often renewed. Even though the risk factors that could lead to delayed wound healing were reduced in the test group, we could not identify any significant difference pertaining to delayed wound healing that required surgical treatment.

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Self-Limiting versus Rotary Subjective Carious Tissue Removal: A Randomized Controlled Clinical Trial—2-Year Results

Journal of Clinical Medicine ◽

10.3390/jcm9092738 ◽

2020 ◽

Vol 9 (9) ◽

pp. 2738

Author(s):

Ahmed H. Ali ◽

Farah Ben Thani ◽

Federico Foschi ◽

Avijit Banerjee ◽

Francesco Mannocci

Keyword(s):

Clinical Trial ◽

Final Analysis ◽

The Self ◽

Controlled Clinical Trial ◽

Randomized Controlled Clinical Trial ◽

Randomized Controlled ◽

Carious Lesions ◽

Tissue Removal ◽

Significant Difference ◽

Deep Carious Lesions

Background: the aim of this study was to assess the 2-year pulp survival of deep carious lesions in teeth excavated using a self-limiting protocol in a single-blind randomized controlled clinical trial. Methods: At baseline, 101 teeth with deep carious lesions in 86 patients were excavated randomly using self-limiting or control protocols. Standardized clinical examination and periapical radiographs of teeth were performed after 1- and 2-year follow-ups (REC 14/LO/0880). Results: During the 2-year period of the study, 24 teeth failed (16 and 8 at T12 and T24, respectively). Final analysis shows that 39/63 (61.9%) of teeth were deemed successful (16/33 (48.4%) and 23/30 (76.6%) in the control and experimental groups, respectively with a statistically significant difference (z score = 2.3, p = 0.021). Of teeth with severe and mild symptoms at T0, 42.9% and 36.7% respectively failed at T24 (p > 0.05). Within the self-limiting group, there was a lower success in premolars compared to molars (p < 0.05). Conclusion: after 2 years, there was a statistically significant higher pulp survival rate of teeth with deep carious lesions excavated using self-limiting protocols in patients with reversible pulpitis. Molars showed higher success than premolars in teeth excavated using the self-limiting protocol. There was no statistically significant association between the outcome and the severity of symptoms at T0 (ClinicalTrials.gov NCT03071588).

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Comparison of the Efficacy and Safety of Trabeculectomy with Mitomycin C According to Concentration: A Prospective Randomized Clinical Trial

Journal of Clinical Medicine ◽

10.3390/jcm10010059 ◽

2020 ◽

Vol 10 (1) ◽

pp. 59

Author(s):

Bo Ram Seol ◽

Sang Yoon Lee ◽

Yu Jeong Kim ◽

Young Kook Kim ◽

Jin Wook Jeoung ◽

...

Keyword(s):

Clinical Trial ◽

Mitomycin C ◽

Proportional Hazard ◽

Efficacy And Safety ◽

Choroidal Detachment ◽

Success Rates ◽

Proportional Hazard Model ◽

Prospective Randomized Clinical Trial ◽

Significant Difference ◽

Low Rate

(1) Background: Mitomycin C (MMC) is commonly used during trabeculectomy. However, there is no consensus on which concentration should be used. We aimed to compare the efficacy and safety of 0.2 mg/mL and 0.4 mg/mL of MMC in eyes undergoing trabeculectomy. (2) Methods: Thirty-six eyes (36 glaucoma patients) were randomized to undergo a trabeculectomy with 0.2 mg/mL or 0.4 mg/mL of MMC. The success rate was evaluated according to three criteria: (A) intraocular pressure (IOP) ≤ 18 mmHg and IOP reduction ≥ 20%; (B) IOP ≤ 15 mmHg and IOP reduction ≥ 25%; (C) IOP ≤ 12 mmHg and IOP reduction ≥ 30%. Cox’s proportional hazard model was used to identify the predictive factors for failure. Immunohistochemical procedures for matrix metalloproteinase (MMP) were performed on Tenon’s tissue. Bleb morphology was evaluated. Safety was assessed based on the incidence of complications. (3) Results: Of the 36 eyes, 19 underwent trabeculectomy with 0.2 mg/mL of MMC and 17 with 0.4 mg/mL. The success rates were 75%, 67%, and 47% at 6 months for criteria A, B, and C, respectively. There were no significant differences between the two groups. High MMP-9 staining and low preoperative IOP were associated with failure (hazard ratio (HR), 5.556; p = 0.033, and HR, 0.936; p = 0.033). Complications included hypotony in two eyes (6%), hyphema in one eye (3%), and choroidal detachment in one eye (3%). (4) Conclusions: Trabeculectomy with 0.2 mg/mL and 0.4 mg/mL of MMC showed similar IOP-control effects to those recorded in previous studies, along with a low rate of complications. There was no significant difference in efficacy or safety between the 0.2 mg/mL and 0.4 mg/mL MMC groups.

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