Hemostatic Efficacy of Oxidized Regenerated Cellulose Powder in Le Fort 1 Osteotomy.

A challenging aspect of Le Fort I osteotomy is bleeding control. Osteotomy techniques, devices, drugs, and anesthetic management have been reported to reduce bleeding; however, there are no reports on the use of hemostatic agents. We aimed to evaluate the hemostatic efficacy of a new topical absorbent hemostatic agent, Surgicel Powder, consisting of oxidized regenerated cellulose (ORC). We reviewed the records of 40 patients who underwent Le Fort I surgery for jaw deformities, with or without cleft lip and palate. Twenty of the 40 patients did not have cleft lips or cleft palates (CLCP); the remaining 20 had CLCP. In each group, an absorbent hemostatic agent was used in 10 patients but not in the other 10. Total blood loss and operative time for each group were evaluated. In the jaw deformity without CLCP group, the amount of bleeding with or without ORC was 112.0±33.8 and 158.6±75.3 mL, respectively, with a significant difference between groups ( P <0.05). Operative time with or without ORC was 206.4±31.3 and 238.3±42.5 minutes, respectively, with a significant difference observed between groups ( P <0.05). In the jaw deformity with CLCP group, the amount of bleeding with or without ORC was 199.7±64.6 and 476.8±104.8 mL, respectively, with a significant difference between groups ( P <0.05). Operative time with or without ORC was 213.7±27.6 and 220.8±41.5 minutes, respectively, with no significant difference between groups ( P =0.329). In conclusion, oxidized regenerated cellulose powder may be a beneficial hemostatic agent for reducing blood loss during Le Fort I osteotomy.

Comparison of skin graft donor site management using oxidised regenerated cellulose (ORC)/collagen/silver-ORC with absorptive silicone adhesive border and transparent film dressing vs semi-occlusive dressings.

Split-thickness skin grafts (STSG) are widely used in wound reconstruction. However, donor site wounds are created as a result. Traditionally, moist wound healing and transparent film dressings have been used to promote donor site wound healing. This retrospective study evaluated the use of oxidised regenerated cellulose (ORC)/collagen/silver-ORC dressing (ORC/C/Ag-ORC) with an absorptive silicone adhesive border dressing and transparent film dressing (treatment) compared with petrolatum-based gauze dressing (control) over donor site wounds. Patients underwent an STSG procedure between January and December 2020. Donor sites received treatment (n = 10) or control (n = 10) dressings. Dressing changes occurred as necessary. Time to epithelialisation, narcotic pain medication requirements, and the number of office/hospital visits were examined. Twenty patients were managed (9 males, 11 females, average age: 49.7 ± 13.9 y). Patient comorbidities included hypertension, diabetes, and hyperlipidemia. Wound types included traumatic and cancer excision. Time to epithelialisation was significantly reduced in the treatment group (11.1 ± 1.4 d vs 18 ± 2.4 d, P < 0.0001). The number of office visits for dressing changes was significantly lower in the treatment group (0.1 ± 0.3 vs 2 ± 0.7, P < 0.0001). No patients in the treatment group required a hospital visit, compared with 3 patients in the control group. One patient in the treatment group required narcotic pain medication, compared with 5 in the control group. In this patient population, the use of ORC/C/Ag-ORC, an absorptive silicone adhesive border dressing, and transparent film dressing resulted in a shorter time to epithelialisation and less analgesic requirement compared with petrolatum-based gauze dressing use.

Comparison between two different local hemostatic methods for dental extractions in patients on dual antiplatelet therapy: a within-person, single-blind, randomized study.

BACKGROUND: Dual antiplatelet therapy (DAPT) provides additional risk reduction of ischemic events compared to aspirin monotherapy, at cost of higher bleeding risk. There are few data comparing new techniques for reducing bleeding after dental extractions in these patients. PURPOSE: This study investigated the effectiveness of the HemCon Dental Dressing (HDD) compared to oxidized cellulose gauze. MATERIALS AND METHODS: This randomized study included 60 patients on DAPT who required at least two dental extractions (120 procedures). Each surgical site was randomized to HDD or oxidized regenerated cellulose gauze as the local hemostatic method. Intra-oral bleeding time was measured immediately after the dental extraction and represents our main endpoint for comparison of both hemostatic agents. Prolonged bleeding, platelet reactivity measured by Multiplate Analyser (ADPtest and ASPItest) and tissue healing comparison after 7 days were also investigated. RESULTS: Intra-oral bleeding time was lower in HDD compared with control (2 [2-5] vs. 5 [2-8] minutes, P=0.001). Prolonged postoperative bleeding was observed in 7 cases (11.6%), all of them successfully managed with local sterile gauze pressure. More HDD treated sites presented better healing when compared with control sites [21 (36.8%) vs. 5 (8.8%), P=0.03]. There was poor correlation between platelet reactivity and intra-oral bleeding time. CONCLUSIONS: In patients on DAPT, HDD resulted in a lower intra-oral bleeding time compared to oxidized cellulose gauze after dental extractions. Moreover, HDD also seems to improve healing conditions.

Retrospective real-world comparative effectiveness of ovine forestomach matrix and collagen/ORC in the treatment of diabetic foot ulcers.

The retrospective pragmatic real-world data (RWD) study compared the healing outcomes of diabetic foot ulcers (DFUs) treated with either ovine forestomach matrix (OFM) (n = 1150) or collagen/oxidised regenerated cellulose (ORC) (n = 1072) in out-patient wound care centres. Median time to wound closure was significantly (P = .0015) faster in the OFM group (14.6 ± 0.5 weeks) relative to the collagen/ORC group (16.4 ± 0.7). A sub-group analysis was performed to understand the relative efficacy in DFUs requiring longer periods of treatment and showed that DFUs treated with OFM healed up to 5.3 weeks faster in these challenging wounds. The percentage of wounds closed at 36 weeks was significantly improved in OFM treated DFUs relative to the collagen/ORC. A Cox proportional hazards analysis showed OFM-treated wounds had a 18% greater probability of healing versus wounds managed with collagen/ORC, and the probability increased to 21% when the analysis was adjusted for multiple variables. This study represents the first large retrospective RWD analysis comparing OFM and collagen/ORC and supports the clinical efficacy of OFM in the treatment of DFUs.

Breast conserving surgery using oxidized regenerated cellulose as filling biomaterial: recommendations to improve clinical outcomes.

Oxidized regenerated cellulose is considered an optimal local hemostatic agent thanks to its favorable biocompatibility, absorption characteristics and ease-of-use. Recently, oxidized regenerated cellulose has also been used as a filler in breast conserving surgery with a reconstructive purpose in order to repair partial breast defects and improve aesthetic outcomes. However, some postoperative problems due to its use, such as allergic reactions, seroma, foreign-body reaction and misdiagnosis during the follow-up of breast cancer patients, have been shown. These possible surgical complications can undermine clinical outcomes and lead to delay the beginning of oncological treatments with a negative impact on patient quality of life and survival. An adequate surgical expertise and the compliance with some specific recommendations are crucial in order to minimize postoperative issues and optimise aesthetic outcomes.

Clinical observation of the regeneration process of defects after breast cancer resection.

BACKGROUND: The present study aims to use two different kinds of filling materials, oxidized regenerated cellulose and gelatin sponge, to repair defects of breast-conserving surgery due to breast cancer, and compare the clinical efficacy, cosmetic effect and complication rate among groups. METHODS: A total of 125 patients, who had breast -conserving surgery due to breast cancer, were enrolled into the present study. Postoperative efficacy was assessed by a doctor and patient, according to the Harvard/NSABP/RTOG Breast Cosmetic Grading Scale. RESULTS: Among these patients, 41 patients received conventional breast-conserving surgery, and 84 patients received breast-conserving surgery plus filling implantation (41 patients in the oxidized regenerated cellulose group and 43 patients in the gelatin sponge group). All patients had small to medium sized breasts (cup size A and B). The average weight of tumor tissues was 56.61 ± 11.57 g in the conventional breast-conserving surgery group, 58.41 ± 8.53 g in the oxidized regenerated cellulose group, and 58.77 ± 9.90 g in the gelatin sponge group. The difference in pathological factors, average operation time, length of stay and local infection rate was not statistically significant among the three groups. 18 patients in the oxidized regenerated cellulose group and 15 patients in the gelatin sponge group were evaluated to have a good cosmetic effect by the surgeon and patient, while 12 patients in the conventional breast-conserving surgery group were evaluated to be have good cosmetic effect by the surgeon and patient. The cosmetic effects in the oxidized regenerated cellulose group and gelatin sponge group were comparable, and these were superior to those in the conventional breast-conserving surgery group. CONCLUSION: The use of oxidized regenerated cellulose and gelatin sponge is a feasible approach for defect repair after breast-conserving surgery.

Barrier agents for adhesion prevention after gynaecological surgery.

BACKGROUND: Pelvic adhesions can form secondary to inflammation, endometriosis, or surgical trauma. Strategies to reduce pelvic adhesion formation include placing barrier agents such as oxidised regenerated cellulose, polytetrafluoroethylene, and fibrin or collagen sheets between pelvic structures. OBJECTIVES: To evaluate the effects of barrier agents used during pelvic surgery on rates of pain, live birth, and postoperative adhesions in women of reproductive age. SEARCH METHODS: We searched the following databases in August 2019: the Cochrane Gynaecology and Fertility (CGF) Specialised Register of Controlled Trials, MEDLINE, Embase, the Cumulative Index to Nursing and Allied Health Literature (CINAHL), PsycINFO, the Cochrane Central Register of Controlled Trials (CENTRAL), Epistemonikos, and trial registries. We searched reference lists of relevant papers, conference proceedings, and grey literature sources. We contacted pharmaceutical companies for information and handsearched relevant journals and conference abstracts. SELECTION CRITERIA: Randomised controlled trials (RCTs) on the use of barrier agents compared with other barrier agents, placebo, or no treatment for prevention of adhesions in women undergoing gynaecological surgery. DATA COLLECTION AND ANALYSIS: Three review authors independently assessed trials for eligibility and risk of bias and extracted data. We calculated odds ratios (ORs) or mean differences (MDs) with 95% confidence intervals (CIs) using a fixed-effect model. We assessed the overall quality of the evidence using GRADE (Grades of Recommendation, Assessment, Development and Evaluation) methods. MAIN RESULTS: We included 19 RCTs (1316 women). Seven RCTs randomised women; the remainder randomised pelvic organs. Laparoscopy (eight RCTs) and laparotomy (11 RCTs) were the primary surgical techniques. Indications for surgery included myomectomy (seven RCTs), ovarian surgery (five RCTs), pelvic adhesions (five RCTs), endometriosis (one RCT), and mixed gynaecological surgery (one RCT). The sole indication for surgery in three of the RCTs was infertility. Thirteen RCTs reported commercial funding; the rest did not state their source of funding. No studies reported our primary outcomes of pelvic pain and live birth rate. Oxidised regenerated cellulose versus no treatment at laparoscopy or laparotomy (13 RCTs) At second-look laparoscopy, we are uncertain whether oxidised regenerated cellulose at laparoscopy reduced the incidence of de novo adhesions (OR 0.50, 95% CI 0.30 to 0.83, 3 RCTs, 360 participants; I² = 75%; very low-quality evidence) or of re-formed adhesions (OR 0.17, 95% CI 0.07 to 0.41, 3 RCTs, 100 participants; I² = 36%; very low-quality evidence). At second-look laparoscopy, we are uncertain whether oxidised regenerated cellulose affected the incidence of de novo adhesions after laparotomy (OR 0.72, 95% CI 0.42 to 1.25, 1 RCT, 271 participants; very low-quality evidence). However, the incidence of re-formed adhesions may have been reduced in the intervention group (OR 0.38, 95% CI 0.27 to 0.55, 6 RCTs, 554 participants; I² = 41%; low-quality evidence). No studies reported results on pelvic pain, live birth rate, adhesion score, or clinical pregnancy rate. Expanded polytetrafluoroethylene versus oxidised regenerated cellulose at gynaecological surgery (two RCTs) We are uncertain whether expanded polytetrafluoroethylene reduced the incidence of de novo adhesions at second-look laparoscopy (OR 0.93, 95% CI 0.26 to 3.41, 38 participants; very low-quality evidence). We are also uncertain whether expanded polytetrafluoroethylene resulted in a lower adhesion score (out of 11) (MD -3.79, 95% CI -5.12 to -2.46, 62 participants; very low-quality evidence) or a lower risk of re-formed adhesions (OR 0.13, 95% CI 0.02 to 0.80, 23 participants; very low-quality evidence) when compared with oxidised regenerated cellulose. No studies reported results regarding pelvic pain, live birth rate, or clinical pregnancy rate. Collagen membrane with polyethylene glycol and glycerol versus no treatment at gynaecological surgery (one RCT) Evidence suggests that collagen membrane with polyethylene glycol and glycerol may reduce the incidence of adhesions at second-look laparoscopy (OR 0.04, 95% CI 0.00 to 0.77, 47 participants; low-quality evidence). We are uncertain whether collagen membrane with polyethylene glycol and glycerol improved clinical pregnancy rate (OR 5.69, 95% CI 1.38 to 23.48, 39 participants; very low-quality evidence). One study reported adhesion scores but reported them as median scores rather than mean scores (median score 0.8 in the treatment group vs median score 1.2 in the control group) and therefore could not be included in the meta-analysis. The reported P value was 0.230, and no evidence suggests a difference between treatment and control groups. No studies reported results regarding pelvic pain or live birth rate. In total, 15 of the 19 RCTs included in this review reported adverse events. No events directly attributed to adhesion agents were reported. AUTHORS' CONCLUSIONS: We found no evidence on the effects of barrier agents used during pelvic surgery on pelvic pain or live birth rate in women of reproductive age because no trial reported these outcomes. It is difficult to draw credible conclusions due to lack of evidence and the low quality of included studies. Given this caveat, low-quality evidence suggests that collagen membrane with polyethylene glycol plus glycerol may be more effective than no treatment in reducing the incidence of adhesion formation following pelvic surgery. Low-quality evidence also shows that oxidised regenerated cellulose may reduce the incidence of re-formation of adhesions when compared with no treatment at laparotomy. It is not possible to draw conclusions on the relative effectiveness of these interventions due to lack of evidence. No adverse events directly attributed to the adhesion agents were reported. The quality of the evidence ranged from very low to moderate. Common limitations were imprecision and poor reporting of study methods. Most studies were commercially funded, and publication bias could not be ruled out.

Novel Minimally Invasive Technique of Neovaginoplasty Using an Absorbable Adhesion Barrier.

Our objective was to provide a minimally invasive neovaginoplasty technique to construct a nearly physiologic vagina to facilitate sexual functioning and appropriate vaginal length in patients with congenital vaginal agenesis. This retrospective study at a tertiary care hospital comprised 52 patients with congenital vaginal agenesis because of Mayer-Rokitansky-Küster-Hauser syndrome or androgen insensitivity syndrome presented for vaginal reconstruction. Modified McIndoe vaginoplasty was done in all patients between 2010 and 2018 using a vaginal mold created with glove, nonadherent petroleum gauze, and Interceed absorbable adhesion barrier (Ethicon, Johnson & Johnson, Somerville, NJ) that was placed in the neovagina space created between the bladder and rectum for 7 days. Operative details, complications, length and width of the neovagina, and functional outcome were evaluated. The mean operation time was 35 minutes. The mean length of the constructed neovagina was 8.4 cm × 3.4 cm at 6 weeks follow-up. Epithelialization was completed by 4 to 6 months. All patients reported satisfactory sexual activity with no pain and good mucosal sensitivity. This modified neovaginoplasty technique is easy to perform, involves painless postoperative dilatations as the cornerstone of treatment, and results in adequate secretion, allowing lubrication and acceptable physiologic results.

Efficacy and safety of regenerated cellulose topical gauze haemostats in managing secondary haemostasis: a randomised control trial.

OBJECTIVE: To compare the efficacy and safety of HemoStyp (United Health Products, US), a neutralised oxidised regenerated cellulose (NORC) and Surgicel (Johnson & Johnson, US), an oxidised regenerated cellulose (ORC), in the management of bleeding of surgical wounds during abdominal, thoracic and vascular surgeries. METHOD: This study was a prospective, non-inferiority, multicentre, randomised, open-label trial. Surgical procedures were performed according to expected standard of care and in compliance with all relevant laws and institutional guidelines. Patients who developed Lewis Bleeding Scale grade 1 and grade 2 bleeds not controlled through conventional techniques were randomised to either the NORC or ORC treatment arms. Bleeding was measured every 30 seconds after treatment, ending at five minutes after haemostasis was achieved or at 10 minutes if haemostasis was not achieved. RESULTS: A total of 236 patients were included in the study. There was a total of seven adverse events in the study, none of which had causality related to either the NORC or ORC. For all surgical procedures, haemostasis was achieved more quickly with the NORC than the ORC (p<0.0001). In addition, haemostasis for all patients was achieved in under two minutes for the NORC compared with 81% of patients in the ORC groups. For Lewis Bleeding Scale grade 1 bleeds, the median time to control bleeding was 24 seconds in the NORC group and 51 seconds for the ORC group. For grade 2 bleeds, time to control bleeding was 76 seconds and 116 seconds, respectively. CONCLUSION: For patients in this study, haemostasis was achieved more quickly in the NORC treatment group compared with the ORC group, in patients with Lewis grade 1 or 2 bleeds caused by surgical wounds generated during abdominal, thoracic and vascular surgeries.

A novel dual-covering method in video-assisted thoracic surgery for pediatric primary spontaneous pneumothorax.

BACKGROUND: Primary spontaneous pneumothorax (PSP) generally occurs in young adults, whereas pediatric PSP is uncommon. It is difficult to source reliable data on pediatric PSP, the management of which is based on guidelines for adult PSP; however, the rate of recurrence after video-assisted thoracoscopic surgery (VATS) for pediatric PSP is reported to be higher. METHODS: We reviewed retrospectively a collective total of 66 surgical cases of a first pneumothorax episode in 46 children under 16 years of age, who were treated at our hospital between February, 2005 and November, 2017. RESULTS: The surgical cases were divided into two groups, depending on how the treated lesions were covered. In the dual-covering (DC) group, the PSP was covered by oxidized regenerated cellulose and polyglycolic acid (8 patients; 13 cases) and in the single-covering (SC) group, the PSP was covered by oxidized regenerated cellulose (38 patients; 53 cases). There was no incidence of recurrence after surgery in the DC group, but 17 cases (32.1%) of recurrence after surgery in the SC group. This difference was significant. CONCLUSION: The DC method prevented the recurrence of PSP more effectively than the SC method after VATS in pediatric patients. Long-term follow-up after VATS for pediatric PSP is also important because of the risk of delayed recurrence.

Bleeding from lumbar ventral epidural venous plexus managed with hemostatic agent from oxidized non-regenerated cellulose.

INTRODUCTION: Bleeding from epidural blood vessels may be an unpleasant complication during surgery of the lumbar spine, which is often difficult to manage with electrocoagulation. The use of local hemostatic agents is a possible solution. This paper presents the first experience with an agent of oxidized non-regenerated cellulose. METHODS: The agent of oxidized non-regenerated cellulose was used in 21 patients (12 women and 9 men) to stop bleeding from the ventral epidural lumbar venous plexus. It was always removed before the end of the operation. RESULTS: In all cases, bleeding was stopped within 2 minutes. Bleeding did not recur until the end of surgery (even after removal of the agent). No early or other complications were observed in the patients studied. CONCLUSION: The agent of oxidized non-regenerated cellulose appears to be a rational and effective solution for bleeding from epidural veins in the lumbar spine.

Subhepatic mass occurrence after using oxidized and regenerated cellulose polymer in laparoscopic cholecystectomy: a case series.

BACKGROUND: Oxidized regenerated cellulose (ORC) is a bioabsorbable surgical hemostatic. We present the first prospective case series of circumscribed mass occurrence after using ORC in laparoscopic cholecystectomy. METHODS: Tabotamp (Ethicon, Inc., Somerville, NJ) in the form of tightly woven knitted patches was used to achieve hemostasis in 83 patients submitted to LC. RESULTS: A subhepatic mass was detected in five patients and radiologic characteristics were described. Abdominal contrast enhanced CT showed a heterogeneous soft-tissue mass. NMR was performed in one patient and showed a T2-weighted hyperintense mass. CONCLUSION: ORC retention after surgery is not uncommon at long-term follow-up. The radiologic characteristics of a suspected ORC retention mass can differentiate it from a neoplastic lesion, so that surgery can be avoided.

Topping Phenomenon with Recurrent Spinal Stenosis and Epidural Fibrosis Prevented with Oxidized Cellulose - a Case Report.

Lumbar spinal stenosis is a condition where the neural structures are compressed in the narrowed spinal canal and often situated only within a single specific segment of the spine, most frequently in the lumbar spine. A case report demonstrates a surgical solution of lumbar spinal stenosis with using oxidized cellulose as a prevention of post-operative adhesions and failed back syndrome. A female patient (68) with a significant pain of the lumbar spine lasting for a number of months due to advanced spondylosis, failing to respond to conservative treatment underwent instrumented, posterolateral fusion of affected segments. The patient re-arrived with pain due to spinal stenosis in another segments after 4 and then after 3 years. We repeatedly performed spinal fusion of the affected segments and applied an antiadhesive gel to the dural sac and the decompressed nerve roots to prevent the development of post-operative adhesions and the "failed back syndrome". Last surgical solution included mobilisation of the simultaneously constricted dural sac through laminectomy. This time we covered the sac using a haemostat made of oxidized cellulose (Traumacel FAM). After this treatment, the patient was again without significant difficulties.

Oxidized, Regenerated Cellulose Adhesion Barrier Plus Intrauterine Device Prevents Recurrence After Adhesiolysis for Moderate to Severe Intrauterine Adhesions.

STUDY OBJECTIVE: To compare the efficacy of an oxidized, regenerated cellulose adhesion barrier (Interceed; Ethicon, Somerville, NJ) combined with an intrauterine device (IUD) versus an IUD alone for preventing adhesion recurrence following hysteroscopic adhesiolysis for moderate to severe intrauterine adhesions (IUAs). DESIGN: Retrospective case series (Canadian Task Force classification III). SETTING: Tertiary care teaching hospital. PATIENTS: Patients undergoing treatment for moderate to severe IUAs. The severity of IUA was determined based on the American Fertility Society scoring system (mild, moderate, or severe). INTERVENTIONS: All cases of hysteroscopic adhesiolysis were reviewed. MEASUREMENTS AND RESULTS: Seventy-six women with moderate to severe IUAs treated between March 2009 and August 2015 were included. After hysteroscopic adhesiolysis, 35 patients were treated with an IUD alone (group 1), and 41 patients were treated with Interceed plus an IUD (group 2). A second hysteroscopy was performed in all cases three months after the initial hysteroscopy and both groups achieved significant reduction in adhesion scores and grade, especially in group 2 (scores, p < .001; grade, p = .039). Compared with group 1, menstruation dysfunction, pregnancy rate, and live birth rate in group 2 improved with no statistical difference (menstruation improvement, p = .764; pregnancy rate, p = .310; live birth rate, p = .068). However, an adhesion-free uterine cavity was regained significantly owing to the fewer operations in group 2 compared with group 1 (median, 3 vs 4; p = .001). The interval from initial hysteroscopy to conception was significantly shorter in group 2 (median, 12 months vs 51 months; p < .001). CONCLUSIONS: For moderate to severe IUAs, Interceed combined with an IUD may be an alternative approach for reducing adhesion recurrence after hysteroscopic adhesiolysis.

The Effectiveness of Oxidized Regenerated Cellulose as a Graft Material in Transalveolar Osteotome Sinus Lift Procedure.

The posterior maxilla is challenged with postextraction alveolar bone resorption and pneumatization drive of the Schneiderian membrane that reduces the subantral distance. To overcome such anatomic obstacle a sinus augmentation procedure was introduced either via lateral or crestal approach depending on residual ridge height. The current study evaluated oxidized regenerated cellulose (ORC) as a grafting material versus osteon II by measuring bone gain and graft density, 24 weeks postoperatively. Twenty consecutive patients (24 cases) aged from 20 to 65 years were considered eligible after clinical and radiographic evaluation. These patients were allocated in 2 groups (study and control) that underwent transcrestal osteotome antral membrane balloon elevation and surgical void augmentation with ORC in the study group, while the control group grafted with collagen membrane and osteon II with simultaneous dental implant placement in both groups and were followed up for 1 year. Cone beam computed tomography was taken for all patients preoperatively and postoperatively to verify neoformed bone and density in Hounsfield units (HU). The mean gained height of the bone was 6.48 mm (5.94 mm in the study and 7.02 mm in the control). The mean density of graft above implant apex was 497.99 HU (434.23 HU in the study and 561.75 HU in the control). Apart from Schneider membrane thickening in 2 patients from the control group, there were no serious complications reported throughout the study. These results demonstrate that ORC is a reasonable grafting material with comparable outcomes when compared to osteon II with less postoperative complications.

Effect of Suturation Plus Surgicel Application on Post-Tonsillectomy Bleeding and Pain.

OBJECTIVE: The aim of this study was to evaluate the effect of suturation (tonsillary fossa closure) plus Surgicel application on postoperative bleeding and pain after tonsillectomies performed using a classical dissection method. STUDY DESIGN: A prospective, randomized, double-blind, clinical trial was performed on 760 patients undergoing tonsillectomy or adenotonsillectomy during a 5-year period. METHODS: After excluding patients with hemorrhagic disorder, chronic disease, and peritonsillar abscess, both tonsils were removed via classic dissection technique (cold knife or blunt dissection) and then electrocauterized for hemostasis. The tonsillar fossa randomly assigned to the treatment protocol (Group 1) was closed by sutures, following Surgicel application. The other side was unaltered and acted as the control (Group 2). Pain was evaluated every day for 10 days postoperatively, and bleeding was reported at any time. RESULTS: A total of 760 patients (393 males, 367 females) between the ages of 4 and 35 years (mean age 13.46 ±â€Š7.98) were included in the study. Bleeding was observed in 31 patients: 8 from Group 1; and 23 from Group 2 (95% confidence interval [CI], P < 0.05). The average pain score was greater in Group 1 than in Group 2 on each postoperative day (95% CI, P < 0.05). CONCLUSION: Suturation plus Surgicel application increased pain levels while decreasing bleeding incidence during the postoperative period.

The Effects of Colchicine-Impregnated Oxidized Regenerated Cellulose on Capsular Contracture.

Capsular contracture is the most common complication of breast augmentation. Oxidized regenerated cellulose can be used as a matrix for drug transport. Colchicine is an antimitotic drug that interferes with various steps of wound healing. The aim of this study was to evaluate the effects of oxidized regenerated cellulose alone or in combination with colchicine on capsular contracture. Twenty-one adult female Wistar-Albino rats were divided into 3 groups. In group 1 silicone blocks only, in group 2 oxidized regenerated cellulose-wrapped silicone blocks, and in group 3 colchicine-impregnated oxidized regenerated cellulose-wrapped silicone blocks were inserted in the dorsal region. Four weeks later, implants were removed and histopathological examination was performed. Capsular thickness, inflammatory infiltrate degree, collagen fiber organization, and myofibroblast density were evaluated. Macroscopic examination revealed a distinct capsule formation only in group 1 animals, with average measurement being 134.65 µm on histopathological examination. In groups 2 and 3 animals, no distinct capsule formation was seen. Inflammatory infiltrate degree was found to be less in groups 2 and 3 animals than in group 1 animals. Collagen fiber organization around the implants was found to be parallel and organized in group 1 animals, whereas it was random and disorganized in animals in both groups 2 and 3. High myofibroblast density was observed in animals in groups 1 and 2, while no myofibroblast was found in animals in group 3. The results of our study suggest that coating silicone implants with oxidized regenerated cellulose or with colchicine-impregnated oxidized regenerated cellulose may be effective in preventing capsular contracture.

Randomized Controlled Trial Comparing Collagen/Oxidized Regenerated Cellulose/Silver to Standard of Care in the Management of Venous Leg Ulcers.

OBJECTIVE: To assess healing outcomes in venous leg ulcers (VLUs) treated with a combination of collagen, oxidized regenerated cellulose, and silver in conjunction with standard of care (SOC; intervention group) compared with SOC alone (control group). Standard of care included ADAPTIC nonadhering dressing (Acelity, San Antonio, Texas) and compression. DESIGN AND SETTING: Randomized controlled trial that followed patients in 3 US facilities for 12 weeks or until complete healing. PATIENTS AND INTERVENTION: Forty-nine patients with VLUs were randomized to either the intervention group (n = 22) or the control group (n = 27). MAIN OUTCOME MEASURE: Wound healing over 12 weeks. MAIN RESULTS: Intent-to-treat analysis showed a mean percentage wound area reduction at 12 weeks of 85.6% (SD, 28.6%) for the intervention group and 72.5% (SD, 77.8%) for the control group. There was a higher healing rate in the intervention group compared with patients who received SOC only at both week 4 (23% vs 11%) and week 12 (64% vs 59%). There were no adverse events related to the study therapy. CONCLUSIONS: Although the results were not significant, there was a trend toward faster healing in the intervention group. The results of this study indicate that collagen/oxidized regenerated cellulose/silver is a suitable and safe adjunctive intervention for use with SOC to manage VLUs.

Effectiveness of collagen/oxidised regenerated cellulose/silver-containing composite wound dressing for the treatment of medium-depth split-thickness skin graft donor site wounds in multi-morbid patients: a prospective, non-comparative, single-centre study.

Split-thickness skin grafting (STSG) is a widely used method in reconstructive surgery, but donor site wounds (DSWs) are often slow healing and painful. This prospective study evaluated the performance of a composite wound dressing containing collagen/oxidised regenerated cellulose in the treatment of medium-depth (0·4 mm) DSWs in 25 multi-morbid patients with chronic leg ulcers requiring STSG. The range of patients' ages was 44-84 years (mean 71·6 years) with DSW sizes ranging between 12 and 162 cm2 (mean 78 cm2 ). Comorbidities included anticoagulation therapy (15 patients), anaemia (11 patients), diabetes (6 patients) and methicillin-resistant Staphylococcus aureus (MRSA) ulcer colonisation (6 patients). The first dressing change was performed after 10 days. Complete reepithelialisation was observed between the 10th and 34th day (mean 17·2, median 14 days). Postoperative medium to strong bleeding occurred in only five patients (four with anticoagulation). Wound pain levels one day after harvesting were only moderate (range 0-1·5, mean 0·5, median 0·5 on a six-item scale). No wound infection was observed during the first dressing. The composite dressing used allowed for the fast healing of medium-depth DSWs with minimal or no postoperative pain and bleeding in older multi-morbid patients under anticoagulation treatment.