Bioinductive Patch as an Augmentation for Rotator Cuff Repair, a Systematic Review and Meta-Analysis.

INTRODUCTION: Rotator cuff tears (RCTs) are a prevalent cause of shoulder pain and dysfunction. For those who fail initial conservative treatment, operative intervention can be pursued. A significant and common complication after rotator cuff repair (RCR) is retearing or non-healing. Numerous augmentations to traditional suture RCR have been studied. Of these, the Smith+Nephew Regeneten bioinductive collagen patch has had promising initial results; however, analytic data for its use is lacking, and there is no meta-analysis comparing the available data to historical RCR outcomes. METHODS: A PRISMA-guided literature search was conducted using Ovid MEDLINE, PubMED, Cochrane, and ClinicalTrials.gov. 13 studies met inclusion and exclusion criteria. Only clinical trials on full and partial-thickness tears were included. American Shoulder and Elbow Surgeon score (ASES), Constant-Murley score (CMS), the visual analog scale for pain (VAS), the minimal clinically important difference (MCID), tendon thickness, and complication rates were primary outcomes of interest. A meta-analysis was performed to determine the overall complication and retear rate from the included studies. RESULTS: ASES, CMS, and VAS improved significantly in all studies that reported them, and most patients achieved MCID. Patient-reported outcome measure (PROM) improvements were similar to historical improvements in standard RCR, and a similar proportion of patients achieved MCID after standard repair. Tendon thickness improved significantly and to a similar degree as standard RCR. Overall retear rate after full thickness RCR augmented with the bioinductive patch was 8.3%. For partial thickness RCR, total retear rate of 1.1% across all patients. The overall complication rate with the bioinductive patch was 15.5% across all full-thickness RCR studies and 16.2% in partial thickness RCR. We found overall retear rate to be lower after augmentation with the bioinductive patch compared to traditional repair; however, the overall complication rate was similar for full-thickness tears and higher for partial-thickness tears. Lastly, adverse reactions to the bioinductive patch were noted at 0.2%. CONCLUSIONS: The bioinductive collagen patch appears to be a safe augmentation for rotator cuff repair. Patients are likely to experience significant subjective improvement in PROMs and significant increases in tendon thickness. Retear rate has been a concern after RCR for decades, and the bioinductive patch may help mitigate this risk. There is a lack of case-control studies comparing the bioinductive patch to traditional suture RCR. Such data is needed to better determine the role of the bioinductive patch in the treatment of full and partial-thickness rotator cuff repairs.

Fibrin glue and coats compromise the integrity of colonic anastomosis: an experimental trial on rats.

Background: Anastomotic leak remains a dreaded complication in colorectal surgery. Identifying optimal techniques that minimize its incidence is an active area of investigation. The aim of this experimental study was to evaluate the effect of commonly used hemostatic products on the integrity of colonic anastomoses. Methods: Male Wistar rats were randomized into 4 groups. In the control group (A), the anastomosis was performed using the standard hand-sewn technique in the ascending colon. In group B the hand-sewn technique was reinforced with a collagen-fibrinogen patch, in group C with fibrin glue, and in group D with a polyethylene glycol (PEG)-coated oxidized cellulose patch. On the 7th postoperative day, anastomotic bursting pressure measurements were obtained. A specimen surrounding the anastomosis was retrieved for histopathologic evaluation. Results: Of the 19 rats, 17 survived and 15 were included in the analysis (5 in each of groups A, B and C). Testing in group D was discontinued following adverse events in the preliminary experiments. The mean bursting pressure of the anastomosis was significantly higher in the control group (A: 221±19.41 mmHg, B: 151±14.42 mmHg, and C: 112±13.57 mmHg; P=0.001). Anastomotic healing parameters were not different between groups. Conclusions: Although experimental data support the use of sealants in defective anastomoses, in this study the reinforcement of colonic anastomosis with fibrin or oxidized cellulose-PEG sealants did not improve either bursting pressure values or anastomotic healing. More data from robust anastomoses of animals and humans are needed before sealing becomes common clinical practice in colorectal surgery.

Collagen patch cover facilitates recovery of bowel function after laparoscopic colectomy.

BACKGROUND: Numerous factors can influence bowel movement recovery and anastomotic healing in colorectal surgery, and poor healing can lead to severe complications and increased medical expenses. Collagen patch cover (CPC) is a promising biomaterial that has been demonstrated to be safe in animal models and has been successfully applied in various surgical procedures in humans. This study. METHODS: A retrospective review of medical records from July 2020 to June 2022 was conducted to identify consecutive patients who underwent laparoscopic colectomy. Patients who received CPC at the anastomotic site were assigned to the collagen group, whereas those who did not receive CPC were assigned to the control group. RESULTS: Data from 241 patients (collagen group, 109; control group, 132) were analyzed. Relative to the control group, the collagen group exhibited a faster recovery of bowel function, including an earlier onset of first flatus (2.93 days vs. 3.43 days, p < 0.01), first defecation (3.73 days vs. 4.18 days, p = 0.01), and oral intake (4.30 days vs. 4.68 days, p = 0.04). CPC use was also associated with lower use of postoperative intravenous analgesics. The complication rates in the two groups did not differ significantly. CONCLUSIONS: CPCs can be safely and easily applied to the anastomotic site during laparoscopic colectomy, and can accelerate bowel movement recovery. Further studies on the effectiveness of CPCs in colorectal surgery involving larger sample sizes are required. CLINICAL TRIAL REGISTRATION: ClinicalTrials.gov registration number: NCT05831956 (26/04/2023).

Therapeutic effect of alternating red and blue light irradiation combined with collagen in patients with acne vulgaris and the risk factors of short-term recurrence.

OBJECTIVE: To explore the therapeutic effect of alternating red and blue light irradiation combined with collagen in patients with acne vulgaris and the risk factors of short-term recurrence. METHOD: A retrospective analysis was conducted on 105 patients with acne vulgaris treated in Baoji Hospital of Traditional Chinese Medicine from January 2019 to February 2020. 50 patients received conventional treatment (Pumen red and blue light) were taken as the control group, and the other 55 patients treated with collagen dressing on the basis of control group were taken as the research group. Clinical efficacy, changes of serum interleukin-1ß (IL-1ß) and interleukin-6 (IL-6) before and after treatment, and the occurrence of adverse reactions were compared between the two groups of patients. The scores of inflammatory skin lesions, facial seborrhea scores, stratum corneum water content and transepidermal water loss (TEWL) were compared before and after the treatment. The 1-year review records of patients were queried, and they were divided into a relapse group and a non-relapse group according to the recurrence situation. Logistic regression was used to analyze the risk factors affecting the recurrence of the patients. RESULTS: The clinical efficacy of the patients in research group after treatment was significantly higher than that in the control group (P<0.05). IL-1ß and IL-6 in the serum of patients after treatment were markedly decreased, and such decline in the research group was more evident after treatment (P<0.05). The incidence of adverse reactions, the scores of inflammatory skin lesions, and facial seborrhea and TEWL in the research group after treatment were all lower than those in the control group (all P<0.05), while the water content of the stratum corneum was higher comparatively (P<0.05). 17 patients were confirmed with recurrence within 1 year after treatment. Logistic regression analysis found that age, monthly income, pre-treatment IL-1ß and pre-treatment IL-6 were risk factors for recurrence. CONCLUSION: Alternating red and blue light irradiation combined with collagen can improve the treatment efficacy in patients with acne vulgaris. And indexes like age, monthly income, pre-treatment IL-1ß and pre-treatment IL-6 are risk factors affecting the recurrence of patients.

Coating of Intestinal Anastomoses for Prevention of Postoperative Leakage: A Systematic Review and Meta-Analysis.

Background: For several decades, scientific efforts have been taken to develop strategies and medical aids for the reduction of anastomotic complications after intestinal surgery. Still, anastomotic leakage (AL) represents a frequently occurring postoperative complication with serious consequences on health, quality of life, and economic aspects. Approaches using collagen and/or fibrin-based sealants to cover intestinal anastomoses have shown promising effects toward leak reduction; however, they have not reached routine use yet. To assess the effects of covering intestinal anastomoses with collagen and/or fibrin-based sealants on postoperative leakage, a systematic review and meta-analysis were conducted. Method: PubMed, Web of Science, Cochrane Library, and Scopus (01/01/1964 to 17/01/2022) were searched to identify studies investigating the effects of coating any intestinal anastomoses with collagen and/or fibrin-based sealants on postoperative AL, reoperation rates, Clavien-Dindo major complication, mortality, and hospitalization length. Pooled odds ratios (ORs) with 95% confidence intervals (CIs) were calculated. Results: Overall, 15 studies (five randomized controlled trials, three nonrandomized intervention studies, six observational cohort studies) examining 1,387 patients in the intervention group and 2,243 in the control group were included. Using fixed-effects meta-analysis (I 2 < 50%), patients with coated intestinal anastomoses presented significantly lower AL rates (OR = 0.37; 95% CI 0.27-0.52; p < 0.00001), reoperation rates (OR, 0.21; 95% CI, 0.10-0.47; p = 0.0001), and Clavien-Dindo major complication rates (OR, 0.54; 95% CI, 0.35-0.84; p = 0.006) in comparison to controls, with results remaining stable in sensitivity and subgroup analyses (stratified by study design, age group, intervention used, location of anastomoses, and indication for surgery). The length of hospitalization was significantly shorter in the intervention group (weighted mean difference (WMD), -1.96; 95% CI, -3.21, -0.71; p = 0.002) using random-effects meta-analysis (I 2 ≥ 50%), especially for patients with surgery of upper gastrointestinal malignancy (WMD, -4.94; 95% CI, -7.98, -1.90; p = 0.001). Conclusion: The application of collagen-based laminar biomaterials or fibrin sealants on intestinal anastomoses can significantly reduce postoperative rates of AL and its sequelae. Coating of intestinal anastomoses could be a step toward effective and sustainable leak prevention. To assess the validity and robustness of these findings, further clinical studies need to be conducted.

A Comparative Study of Using Collagen Patch or Fat Plug in Myringoplasty for Small Tympanic Membrane Perforations.

One of the most common problems in otorhinolaryngology is perforation of tympanic membrane. Although many small perforations heal spontaneously over time, some may remain persistent due to infection or some other causes. In the past years so many grafts have been used with good success rate. In this prospective study of 60 patients with small tympanic membrane perforations, we have compared newer biomaterial collagen patch and conventional fat plug as office procedures in treatment. According to our study, both groups had a significantly equal success rates & the rate of healing & complete closure at the end of 1 & 2 months follow up. The hearing improvement in A-B gap during follow up of both groups were compared with pre-op A-B gap & showed a significant p value. This showed that both collagen patch & fat plug groups had a significant improvement in hearing following procedure. In our study quadrant of perforation does not correlate with the amount of hearing & healing rates were comparatively better in anterior quadrant than posterior quadrant. Infective causes were more & the failure rates were also high for such cause in both groups.

Does intraoperative application of TachoSil reduce the number of lymphoceles after pelvic lymphadenectomy?

OBJECTIVES: The degree of lymphoceles prevention was assessed using collagen patches coated with human coagulation factors (TachoSil, Nycomed International Management GmbH, Zurich, Switzerland). The study enrolled 50 consecutive patients with endometrial and cervical cancer stages IB to II who had undergone open hysterectomy and pelvic lymphadenectomy (PL). In addition, the drainage volumes of 22 patients with hypertension were compared to that of the rest of the study population. Furthermore, occurrence of lymphocele in patients with endometrial and cervical cancer were compared after completion of adjuvant treatment. MATERIAL AND METHOD: s: Patients were simultaneously randomized in two groups: as a control (side without TachoSil applied) and study group (side with TachoSil applied). All surgical parameters were collected, and patients underwent ultrasound examination on postoperative days 1, 6, and 30, and at the end of treatment. RESULTS: The TachoSil Group showed a lower drainage volume, 30 days after surgery, while outflow of fluid occurred in 11 (22%) of all TachoSil Group cases and 22 (44%) of all control group cases. Furthermore, two patients in the control group had symptomatic lymphocele, while the same number of cases was observed in the TachoSil Group. However, the TachoSil Group demonstrated a decreased tendency to lymphocele occurrence after the end of adjuvant therapy. Here, patients with the collagen patch developed lymphocele in 12% of all cases, as opposed to 18% without TachoSil. CONCLUSIONS: TachoSil is a useful support treatment option for reducing drainage volume and preventing lymphocele development after lymphadenectomy.

The painless combination of anatomically contoured titanium plates and porcine dermal collagen patch for chest wall reconstruction.

BACKGROUND: A plethora of new biomaterials and dedicated rib fixator implant systems have been introduced into the field of chest wall reconstruction. The aim of our study is to evaluate the surgical outcomes of a novel combination of the anatomically contoured titanium rib implant and porcine dermal collagen patch for chest wall reconstruction. METHODS: We performed a retrospective review of eight consecutive patients who underwent chest wall resection and reconstruction between January 2014 to August 2015 in a single institution. MatrixRib Fixation System and Permacol Surgical Implant were utilized to achieve chest wall reconstruction. RESULTS: The indication for reconstruction was malignant infiltration in 50% of patients. Three other subjects (37.5%) had chest wall resections to achieve adequate and safe surgical exposure. One patient had a right lung apical mycetoma with chest wall invasion. All patients underwent lung resections with the removal of 2 to 6 (median 3) ribs. Reconstruction was performed using the MatrixRib system, with a median of 2.5 (range, 2-4) ribs fixed in each patient. There was no post-operative mortality. One patient had a superficial wound infection which resolved with one week of oral antibiotics. Upon discharge, the pain scores were near zero with minimal analgesic requirements. None of the patients required repeat surgery or removal of their implants. CONCLUSIONS: Our early experience indicates that the combination of the MatrixRib system and Permacol patch for chest wall reconstruction is safe and feasible with promising results in terms of anatomical restoration of the chest wall mechanics, infection and pain.

Novel transparent collagen film patch derived from duck's feet for tympanic membrane perforation.

To increase healing rate of tympanic membrane (TM) perforations, patching procedure has been commonly conducted. Biocompatible, biodegradable patching materials which is not limited across cultures is needed. The authors evaluated the effectiveness of novel transparent duck's feet collagen film (DCF) patch in acute traumatic TM perforation. This procedure was compared with spontaneous healing and paper patching. Cell proliferation features were observed in paper and DCF patches. Forty-eight TMs of 24 rats were used for animal experiment, perforations were made on each TMs, and divided into three groups according to treatment modality. Sixteen were spontaneously healed, 16 were paper patched and 16 were DCF patched. The gross and histological healing results were analyzed. Both paper and DCF patch showed no cytotoxicity, but cell proliferations were more active in DCF than paper in early stage. In animal study, the healing of TM perforations were completed within 14 days in all three groups, but found to be faster in DCF patch group than paper patch or spontaneous healing group. The DCF patches were transparent and size of DCF patches were gradually decreased, so there were no need to remove the DCF patches to check the wound status or after the completion of healing. According to this result, authors concluded that DCF patch is transparent, biocompatible and biodegradable material, and can induce fast healing in acute traumatic TM perforations.

Treatment of Extensive Gluteus Muscle Tears With Transosseous Fixation and a Nonresorbable Collagen Patch.

BACKGROUND: Extensive tearing of the gluteus muscles (spontaneous or subsequent to hip arthroplasty) is difficult to treat. We are carrying out osseous fixation with securement of the suture anchor by a nonresorbable collagen patch. The objective of this study is to examine the follow-up data of 30 patients and to assess whether the clinical outcomes depended on the extent of the fatty degeneration of the gluteus medius. METHODS: Thirty patients (28 female and 2 male) with a mean age of 76.8 ± 4.3 years (68-83 years) were followed for a mean of 46.8 ± 23.1 months (24-101 months). RESULTS: Pain improved significantly from a preoperative visual analog scale score of 7.0 ± 1.52 (6-10) to 0.83 ± 0.77 (0-3) 24-month postoperative. The gluteus medius muscle force increased from 2.09 ± 0.81 to 3.3 ± 0.78 using the British Medical Research Council Scale. All patients exhibited a severe limp before the operation. Postoperatively, only 5 patients had a severe limp, while 14 exhibited a mild limp and 11 no limp at all. The modified Harris Hip Score increased from a preoperative value of 44.5 ± 4.2 (26-66) to a value of 81.1 ± 7.79 (60-100) 24-month postoperative. The functional results were dependent on the level of fatty degeneration of the muscle. CONCLUSION: The first results for this surgical technique appear to be very promising for the treatment of extensive tearing of the gluteus musculature that has a degree of fatty degeneration less than 75%.

Lesión osteocondral extensa de cóndilo femoral; tratamiento en un tiempo con matriz colágena y concentrado de médula ósea: reporte de un caso / Big osteochondral lesion; treatment with collagen scaffold and bone marrow concentrate: case report

El tratamiento de las lesiones osteocondrales de gran tamaño y profundidad resultan un desafío debido a que las técnicas habituales (microfractura o transplante osteocondral autólogo), son insuficientes para cubrir el defecto; eso es particularmente importante en pacientes jóvenes, pues se debe intentar técnicas que generen la menor comorbilidad posible. Presentamos un caso de un paciente de 18 años con una lesión osteocondral de 6 cm2 por 14 mm de profundidad, tratado mediante autoinjerto óseo, concentrado de médula ósea y matriz colágena, con resultados satisfactorios tanto en lo funcional como en lo imagenológico. Esa técnica presenta la ventaja de realizarse en un tiempo y con una fuente de células troncales mesenquimáticas (Médula ósea), validada en la literatura y altamente reproducible.

The treatment of large osteochondral defects represent a challenge, because the common techniques used (micro fracture or osteochondral autologous transplantation) are insufficient to cover the defect; this is particularly important in young patients where we expect the least comorbidity. We report a case of an 18-year-old patient with an ostechondral injury of 6 cm2 and 14 mm deep, treated with bone autograft, bone marrow concentrate and a matrix of collagen with satisfactory functional and images results. This technique has the advantage to be performed in one single time and with a source of mesenchymal stem cells (bone marrow) validated in the literature.

The Use of Polyvinyl Alcohol Sponge and Cyanoacrylate Glue in the Treatment of Large and Chronic Bronchopleural Fistulae following Lung Cancer Resection.

BACKGROUND: Bronchopleural fistulae represent a relatively rare complication of pulmonary resection. For inoperable patients, several endoscopic procedures have been described. In the presence of large and chronic bronchopleural fistulae, persistent air leaks require a surgical therapy, while endoscopic airway stent represents a useful palliative treatment. OBJECTIVE: We describe the successful closure of large and chronic bronchopleural fistulae using an expandable polyvinyl alcohol (PVA) sponge and cyanoacrylate glue. METHODS: In all patients, a rigid bronchoscope was used to insert a small cylinder of PVA sponge within the fistula. After releasing the patch, cyanoacrylate glue was applied directly on the PVA sponge using a channel catheter. This methodology induces an expansion of the clot and the closure of the air leak. The long-term outcome of treatment was checked by flexible bronchoscopy once every month for 3 months and every 6 months until 5 years. RESULTS: We performed endoscopic treatment in 7 consecutive patients with bronchopleural fistula ranging from 4 to 8 mm. In 6 of 7 patients, the bronchial stump was the site of the fistula. In 1 patient, the fistula was visualized on the right wall of the distal trachea. A temporary complete occlusion of the fistula was achieved in 7 of 7 patients and a definitive result in 5 of 7 patients. CONCLUSIONS: The use of an expandable PVA sponge and cyanoacrylate glue is an available strategy for endobronchial closure of bronchopleural fistulae.

Patch-augmented rotator cuff repair: influence of the patch fixation technique on primary biomechanical stability.

INTRODUCTION: There is an ongoing debate about the potential of patch augmentation to improve biomechanical stability and healing associated with rotator cuff repair. The biomechanical properties of three different patch-augmented rotator cuff repair techniques were assessed in vitro and compared with a standard repair. Dermal collagen patch augmentation may increase the primary stability and strength of the repaired tendon in vitro, depending on the technique used for patch application. METHODS AND MATERIALS: Forty cadaveric sheep shoulders with dissected infraspinatus tendons were randomized into four groups (n = 10/group) for tendon repair using a knotless double-row suture anchor technique. A xenologous dermal extracellular matrix patch was used for augmentation in the three test groups using an "integrated", "cover", or "hybrid" technique. Tendons were preconditioned, cyclically loaded from 10 to 30 N at 1 Hz, and then loaded monotonically to failure. Biomechanical properties and the mode of failure were evaluated. RESULTS: Patch augmentation significantly increased the maximum load at failure by 61 % in the "cover" technique test group (225.8 N) and 51 % in the "hybrid" technique test group (211.4 N) compared with the non-augmented control group (140.2 N) (P ≤ 0.015). For the test group with "integrated" patch augmentation, the load at failure was 28 % lower (101.6 N) compared with the control group (P = 0.043). There was no significant difference in initial and linear stiffness among the four experimental groups. The most common mode of failure was tendon pullout. No anchor dislocation, patch disruption or knot breakage was observed. CONCLUSION: Additional patch augmentation with a collagen patch influences the biomechanical properties of a rotator cuff repair in a cadaveric sheep model. Primary repair stability can be significantly improved depending on the augmentation technique.

The contribution of a collagen-fibrin patch (Tachosil) to prevent the postoperative lymphatic complications after groin lymphadenectomy: a double institution observational study.

OBJECTIVE: Postoperative morbidity associated with groin lymphadenectomy remain high and still represents a major concern for this patients. The aim of this study was to confirm the efficacy of TachoSil(®) in preventing postoperative complications after inguinofemoral lymphadenectomy for gynecological malignancy. STUDY DESIGN: An observational study was conducted to evaluate the incidence of postoperative complications among 49 patients (TachoSil(®) group=24; control group=25) underwent groin dissection enrolled in two Italian Department of Gynecology Oncology from 2011 to 2014. RESULTS: A total of 74 inguinal dissections were performed. Bilateral groin dissection was performed in 25 patients (Tachosil group=10; group 2=15). Patients in TachoSil(®) group showed a lower daily drainage volume with a mean volume of 84 ml (range 30-465) vs. 143 ml (range -72 to 413) in the control group (p=.004), and a lower total drainage volume with a mean of 540 ml (range 90-930) vs. 900 ml (range 200-3270) for Tachosil and control group, respectively. A lower incidence of lymphocyst required drainage, cellulitis, wound infection and late lymphedema was observed in TachoSil group even without reaching statistical significance. CONCLUSIONS: This observational study confirmed that the use of TachoSil(®) seems to be highly effective in reducing the rate of postoperative lymphorrea and postoperative complications after groin dissection in case of gynecological malignancies. Larger multicenter prospective study is advisable to validate our preliminary results.

Further experimental studies on a biodegradable adhesive for protection of colorectal anastomosis.

BACKGROUND AND AIMS: Anastomotic leaks (AL) continue to be a devastating complication after colorectal surgery. The purpose of this experimental study was to confirm if Pebisut® applied to intestinal suture lines increases tensile strength in the critical days of healing and to evaluate its anti-inflammatory properties. METHODS: Bursting pressures and histological evaluation of suture lines in dogs were performed, comparing the burst strength with collagen or fatty tissue patches with/without Pebisut® (patent granted in the USPTO 8,252.333, 26.01.2006, in the European Union 2,062,602, 01.12.2010, in Canada 2,661,686, 21.08.2007 and in Mexico P.C.T./MX/a/2009/001737). RESULTS: Pebisut® significantly increases burst strength in suture lines in long-term procedures with both collagen and fat pad patches. The adhesive penetrates rapidly into the suture lines, sealing them and progressing towards the intestinal lumen, disappearing in 14-20 days. It was well tolerated without any evidence of "foreign body" reaction. CONCLUSIONS: Application of the biodegradable adhesive Pebisut® is easy, well tolerated by mammalian tissues and consistently increases the burst strength of suture lines. Therefore, it may provide more tensile strength in anastomosis and help protect AL, one of the most serious complications in gastrointestinal surgery. If this experimental finding could be translated to clinical surgery, the protection of colorectal anastomosis could be beneficial to patients. Additionally, this could also have a positive impact on the economic expenditures of healthcare systems and patients.