Tension Relief System Research Articles

TopClosure® tension‑relief system improves clinical outcomes of patients with breast cancer undergoing mastectomy.

The present randomized controlled study aimed to investigate the effects of TopClosure® tension-relief system (TRS) on patients with breast cancer undergoing mastectomy. A total of 402 female patients with breast cancer who came to the Renmin Hospital of Wuhan University between March 2014 and June 2018 were involved in the present study. All patients receiving mastectomy were randomly divided into the TRS group (n=201) and the control group (n=201). Serum levels of high-sensitivity C-reactive protein, TNF-α, IL-6 and procalcitonin were measured using ELISA. Vancouver Scar Scale was recorded at 2 weeks and 1-3 and 6 months following the operation. The 36-Item Health Survey Scales were performed for all patients at 1 month after surgery. The TRS reduced the incidence of flap necrosis, infection and the duration of hospital stay. In addition, the TRS was found to attenuate inflammation and improve scar outcomes as well as the quality of life. It was concluded that the TRS could significantly improve the clinical outcomes.

Role of Preoperative Skin Stretching in Single-Stage Wound Closure.

Background Mechanical skin stretching (SS) is now becoming one of the commonly sought after procedures for wound healing. This study was aimed to assess the efficacy of preoperative SS for the closure of large wounds and to evaluate various postoperative outcome parameters. Methodology An observational study was conducted from December 2017 to May 2019 where a sample size of 30 patients was included with inclusion criteria being wounds of ≥5 cm width that require surgical management, presence of sufficient healthy skin edge of the wound/scar (at least one) for the stretching procedure, and age between 18 and 70 years. SS devices used were the top closure tension relief system. Postoperatively, various parameters were recorded to evaluate outcomes and complications. Results Majority of wounds that is 16 (53.3%) were <50 cm 2 , 9 (30%) were between 50 and 75 cm 2 , and 5 (16.7%) were >75 cm 2 . The mean duration of stretch was 2.3 ± 0.82 weeks. For 30 wounds treated with staged cycles of wound closure, there was a significant difference between every two visit points, i.e., 10%. The mean patient-reported patient and observer scar assessment scale score was 3.5 ± 0.93. Twenty-five cases (83.3%) had uneventful postoperative recovery. Twenty-seven patients (90%) reported an improved aesthetic outcome. Fourteen patients (46.7%) reported some improvement in function. Conclusion The study concluded that the SS devices are the simple and effective method for the primary closure of large and challenging wounds and skin defects.

Pediatric Wound Closure by a Tension-Relief System.

Surgical reconstruction in pediatric patients can often be complex. Primary wound closure is almost always the preferred technique in the reconstructive ladder; however, it is not always possible in pediatric patients. We report the pediatric use of the TopClosure Tension-Relief System, an innovative skin-stretching technique for secure primary wound closure of large defects. We modified the technique by fixating it to a protective dressing instead of the patient's skin, thus avoiding both staple scars and pain. A retrospective review of 112 patients aged 7 days to 18 years who underwent Tension-Relief System-assisted surgery at a tertiary medical center from 2010 to 2020 was conducted. Cases included congenital deformities, traumatic wounds, burn scars, and complicated-wounds, with or without hardware or deep tissue exposure. The use of the system avoided the need for multiple surgical sessions and for local or regional flaps. The technique was simple to use, with few complications, and led to satisfactory aesthetic and functional outcomes. The findings support using the technique in children and adolescents with challenging tension wounds. Herein, we report on our experience with the Tension-Relief System and detail four cases in which early or immediate closure was successfully achieved.

Complicated wound closure following mastectomy and breast reconstruction.

Breast reconstruction incidence increased, including preventive surgery. In this context, providing women best surgical care and results is crucial, with minimum complications, such as wound dehiscence and skin flap necrosis. Tension-free closure of skin flaps is mandatory for successful healing. However, since this is not always possible, various techniques have been developed to reduce tension from wound margins, facilitate primary wound closure, and minimize and improve scarring. These techniques have not been investigated in breast surgeries. The aim of this study was to describe our experience with the Tension-Relief System in mastectomy and breast reconstructive patients, and the advantages of using this technique. The retrospective cohort consisted of 13 breasts of 11 women aged 29-74years who underwent surgery with primary wound closure using the System, in 2019-2020 in our department. It was applied averagely 19.7days, demonstrated effectiveness in preventing complications and as secondary treatment following complications. This enabled avoiding further and more extensive surgeries, including donor-site morbidity when needed. In mastectomy and breast reconstruction, the system minimizes complications and yields satisfactory esthetic and functional outcomes, with minimal inconvenience to the patient, and good pain control. The technique is low-cost, simple to use, and does not require special settings, surgical equipment, or particular skills.

Closure of Challenging Pediatric Scalp Wounds by a Tension-Relief System.

Pediatric scalp defects may be challenging, due to their variant tension level and specific etiologies. Tissue characteristics and pre- and post-management considerations may pose difficulties to reconstruction in the pediatric patient. Primary closure is the preferred surgical technique but is not always possible. Various techniques have been described for facilitating primary wound closure, by reducing tension from the skin wound margins. The authors use a tension-relief system in some challenging scalp wounds when simple primary closure cannot be achieved. This enables primary closure without tension on the surgical margins, and may thus preclude the need for other closure techniques such as tissue-expanders, grafts, and flaps. The authors describe our use of a tension-relief system in 21 pediatric patients treated during 2017-2020, for congenital deformities, vascular malformations and other skin lesions, traumatic wounds, burn scars, and complicated surgical wounds with and without hardware exposure. A tension-relief system is a prompt, simple-to-use, safe, and low-cost surgical solution that offers several advantages over other techniques when tension-free primary intention closure is not possible. These benefits include less extensive surgery, fewer surgeries and associated anesthesia, shorter treatment period and hospitalization, better scarring, lower distress and burden to patients and their families, better pain-control, the absence of donor-site with its comorbidities, and less bleeding and risk of damaging adjacent structures. Based on our experience and the system characteristics detailed, the authors recommend using the described technique, which is convenient, accessible, and reliable, to close challenging scalp wounds in pediatric patients.

Minimizing treatment complexity of combat-related soft tissue injuries using a dedicated tension relief system and negative pressure therapy augmented by high-dose in situ antibiotic therapy and oxygen delivery: a retrospective study.

BackgroundFollowing combat-related, extensive soft tissue injury from gunshot wounds or blasts, prolonged duration from injury to full wound closure is associated with infection, increased morbidity and mortality, failure to mobilize, poor functional outcome and increased cost. The purpose of this study was to evaluate a novel treatment enabling early primary closure of combat wounds.MethodsThis was a retrospective study of 10 soldiers and civilians with extensive combat-related soft tissue limb injuries (5 gunshot wounds, 5 blasts) treated using the TopClosure® Tension Relief System (TRS) with simultaneous administration of regulated oxygen-enriched and irrigation negative pressure-assisted wound therapy (ROINPT) via the Vcare α® device.ResultsNine patients were treated during the acute phase of injury and one was treated following removal of a flap due to deep infection 20 years after injury and flap reconstruction. Two patients had upper limb injury and the rest lower limb injury. With the aid of the TRS and/or ROINPT, immediate primary closure during reconstruction was achieved in 6 patients and delayed primary closure in three. Only one patient required a skin graft to close a small area of the wound after most of the wound had been closed by delayed primary closure. Wound closure was achieved within 0–37 days (median: 12.5 days, interquartile range: 2.75–19.75) from injury.ConclusionsThe TRS is a novel device for effective, early skin stretching and secure wound closure through the application of stress relaxation and mechanical creep, achieving primary closure of large defects using a simplified surgical technique and reducing the need for closure using skin grafts and flaps and the use of tissue expanders. Delivering supplemental oxygen to the wound by ROINPT reverses the reduced oxygen levels inherent in conventional negative pressure-assisted wound therapy, mitigating anaerobic contamination and reducing infection. Irrigation may accelerate the evacuation of infectious material from the wound and provide a novel method for antibiotic administration. The combination of TRS and ROINPT devices allow for early primary closure with improved functionality of combat-related limb injuries.

Relaxation Systems of the Skin for the Closure of Large Mammary Defects

In MAMMARY tumors that are large relative to breast-size, complex reconstructive methods are required. We describe an alternative system of closure. In circumstances such as this, primary closure of this skin defect may be enabled by stress relaxation of the skin and the use of a tension-relief system. Tension-relief systems secures immediate primary closure of large skin defects in patients with large for breast-size tumors by placing the tension away from the skin edges. This enables early skin closure and rapid mobilization with good functionality. Optimal healing facilitates postoperative radiotherapy on time without reconstruction failure.

Different skin-stretching devices for the treatment of skin and soft tissue defects

To compare clinical effects of tension-relief system(TRS) and self-made skin-stretching devices in treating skin and soft tissue defects caused by trauma. Totally 41 patients with skin and soft tissue defects caused by trauma treated by skin-stretching devices were retrospectively analyzed from June 2015 to October 2016, including 28 males and 13 females, aged from 22 to 64 years old with an average of(43.2±10.4) years old. The patients were divided into two groups according to therapeutic methods, 18 patients were treated by TRS, including 11 males and 7 females, aged from 22 to 61 years old with an average of (41.7±9.5) years old; 5 patients injured on the upper limb, 11 patients on lower limb and 2 patients on the back; the area of defect ranged from 42 to 160 cm² with an average of(78.6±17.4) cm². Twenty-three patients were treated by self-made skin stretching device, included 17 males and 6 females, aged from 25 to 64 years old with an average of (44.4±12.7) years old; 6 patients injured on the upper limb, 13 patients on lower limb and 4 patients on the back; the area of defect ranged from 54 to 175 cm² with an average of(75.2±14.3) cm². Primary closure at stage I, blood loss, operation time, healing time of wound, complications between two groups were compared, VAS score was used to evaluate pain relief, vancouver scar scale(VSS) was used to assess recover of postoperative scars. Forty-one patients were followed up ranged from 3 to 12 months with an average of(16.2±3.7) months. There were no significant difference between two groups in blood loss and operation time(P>0.05). In TRS group, 16 patients' injury were closured directly, wound healing time of 16 patients were over 3 about weeks, VAS score was 3.9±1.1, VSS score was 3.5±1.2, and 1 patient occurred complication; In self-made skin stretch group, 12 patients' injury were closured directly, wound healing time of 9 patients were over 3 about weeks, VAS score was 4.8±1.4, VSS score was 5.3±1.6, and 9 patients occurred complication; there were no statistical differences between two groups in these items. Compared with self-made skin stretch, TRS has advantages of good effect of wound, minimal trauma, short healing time, less pain, good outlook, and less complication.

Sistemas de relajación de la piel para el cierre de grandes defectos mamarios

In mammary tumors that are large relative to breast-size, complex reconstructive methods are required. We describe an alternative system of closure. In circumstances such as this, primary closure of this skin defect may be enabled by stress relaxation of the skin and the use of a tension-relief system. Tension-relief systems secures immediate primary closure of large skin defects in patients with large for breast-size tumors by placing the tension away from the skin edges. This enables early skin closure and rapid mobilization with good functionality. Optimal healing facilitates postoperative radiotherapy on time without reconstruction failure.

The effect of TopClosure® TRS in the treatment of large abdominal wall defect

Large abdominal wall defects, which are not suitable for primary closure partly due to the expected high tension closure and the considerable rate of recurrence, represent a substantial reconstructive challenge. The study is aimed to evaluate the clinical value of TopClosure® Tension-Relief System (TRS) in the treatment of large abdominal wall defect. Thirteen patients with large abdominal wall defect were treated using TopClosure® TRS, and the average healing time, patients’ satisfaction, and complication were recorded. After being treated with TopClosure® TRS, 10 cases were primary healing, three-case second-intention healing due to the thickened abdominal wall with mild scar. The average healing time and hospitalization time are shortened, while the primary healing rate and VAS satisfactory value improved. Logistic regression analyses indicated that age, BMI, defect area, wound infection, and diabetes may influence the effect of TopClosure® TRS in the repair of large abdominal wall defect. Large abdominal wall defect can be treated using TopClosure® TRS, effectively and easily, which can be generalized to be used in clinics. Level of evidence: Level IV, therapeutic study.

Recent Therapeutic Alternative Methods for Burst Abdomen and its Relation to Development of Incisional Hernia

Background: Burst abdomen is considered one of the most challenging obstacles that facing general surgery. Studying the layers of the abdominal wall, and knowing the anatomy of the anterior abdominal wall, its arterial and nerve supply is the corner stone in management of that surgical problem, and in finding the best way how to close that defect. Objective: The aims of the study were to evaluate and compare between recent therapeutic methods of burst abdomen after elective and emergency laparotomy as regard technical, function and to prevent its complication with its later development of incisional hernia. Patients and Methods: This randomized prospective study was carried out at Al-Azhar University Hospitals and Military production hospital on 20 patients with post-lapraotomy burst abdomen in the period from January 2016 to October 2017. The patients were randomly classified according to the method of abdomen closure into 5 groups; 4 patients each: Group A: Closure with TI, TIE, TIES incisions and component separation technique. Group B: Simple mass closure with continuous sutures. Group C: Closure using a Pedicled Tensor Fascia LataFlap. Group D: Vacuum assisted closure. Group E: Closure with gradual skin stretching by tension relief system(TRS). Results: By the use of TI, TIE, TIES incisions and component separation technique, complete fascial closure was achieved in 3 patients (75%).By the use of mass closure, complete fascial closure was achieved in all patients (100%).By the use of the vacuum assisted closure, complete fascial closure was achieved in all patients (100%) but enterocutaneous fistula was encountered in one patient (25%). By the use of the pedicled tensor fascia lata to close the abdomen, complete fascial closure was achieved in all patients (100%) but recurrence occurred in one patient (25%).By the use of the TRS, complete fascial closure was achieved in 2 patients (50%) Conclusion: Mass closure with continous suture seems to be the best method as the abdominal wall defect is not large as its simple ,easy and cost effective .

A skin stretch system for the immediately closing of the large skin defects of the anterior chest wall following large keloid excision

Large anterior chest wall skin defects following keloid resection, which are not suitable for primary closure, represent a substantial reconstructive challenge, partly due to the expected high tension closure and the considerable rate of recurrence. The TopClosure® Tension Relief System (TRS) is a novel skin stretching and wound closure-secure system which has been shown as a substitute for skin grafts, tissue expanders, and flaps. A 36-year-old man presented with a large keloid with ulcerations on the anterior chest wall. The patient underwent surgical resection of the keloid with immediate primary closure of the chest wall skin defect using the TRS. The surgical procedure and the postoperative period were uncomplicated. The wound was completely closed with a slightly raised scar after the 15th month follow-up. This is a rare case of immediate primary closure of a skin defect following resection of a large keloid of the anterior chest wall by the application of a skin stretching technique named as TRS. The TopClosure® TRS can help simplify the surgical procedures and shorten the operative time. Furthermore, the appliance can also be used for cosmetic improvements of the scar and minimize the need for future reconstructive procedures as well. Level of Evidence: Level V, therapeutic study

Evaluation of a new tension relief system for securing wound closure: a single-centre, Chinese cohort study

Background Wounds that have been closed under excessive tension, and skin defects that cannot be closed primarily, pose a daily challenge for the reconstructive surgeon. Objective To evaluate a new tension relief system (TRS) device for skin stretching and secure wound closure. Methods From September 2013 to March 2014, a consecutive series of 41 Chinese patients with 43 wounds were enrolled for application of 50 cycles of TRS therapy. TRS was used for two main clinical applications: closure of a variety of surgical/traumatic wounds; and securing wound closure after high-tension suture closure. Basic information and details regarding this therapy and its complications were recorded. Follow-up visits were conducted three to six months after wound closure. Results Mean residual wound width decreased approximately 20% every two days during cycles of TRS therapy. Infection was the most common complication (five cases). Other complications included dehiscence (two cases) and pressure ulcer (one case). At the six-month follow-up visit, (21 wounds in 20 patients), both the extent of healing and the scar were acceptable. Discussion There are no absolute contraindications to TRS therapy. The authors have formulated instructions for the prevention and treatment of the most common complications. Conclusions The results demonstrate that TRS therapy is a simple, effective method for primary closure of difficult wounds, and large skin and soft-tissue defects. Larger randomized studies are required to further evaluate of the effectiveness, indications, complications and cost effectiveness of this innovative TRS therapy.

Evaluation of a new tension relief system for securing wound closure: A single-centre, Chinese cohort study.

Wounds that have been closed under excessive tension, and skin defects that cannot be closed primarily, pose a daily challenge for the reconstructive surgeon. To evaluate a new tension relief system (TRS) device for skin stretching and secure wound closure. From September 2013 to March 2014, a consecutive series of 41 Chinese patients with 43 wounds were enrolled for application of 50 cycles of TRS therapy. TRS was used for two main clinical applications: closure of a variety of surgical/traumatic wounds; and securing wound closure after high-tension suture closure. Basic information and details regarding this therapy and its complications were recorded. Follow-up visits were conducted three to six months after wound closure. Mean residual wound width decreased approximately 20% every two days during cycles of TRS therapy. Infection was the most common complication (five cases). Other complications included dehiscence (two cases) and pressure ulcer (one case). At the six-month follow-up visit, (21 wounds in 20 patients), both the extent of healing and the scar were acceptable. There are no absolute contraindications to TRS therapy. The authors have formulated instructions for the prevention and treatment of the most common complications. The results demonstrate that TRS therapy is a simple, effective method for primary closure of difficult wounds, and large skin and soft-tissue defects. Larger randomized studies are required to further evaluate of the effectiveness, indications, complications and cost effectiveness of this innovative TRS therapy.

Tissue loads applied by a novel medical device for closing large wounds

Closure of large soft tissue defects following surgery or trauma as well as closure of large chronic wounds constitutes substantial but common reconstructive challenges. In such cases, an attempt to use conventional suturing will result in high-tension closure, therefore alternative external skin stretching systems were developed. These types of devices were meant to reduce local mechanical loads in the skin and the underlying tissues, taking advantage of the viscoelastic properties of the skin, especially mechanical creep, for primary wound closure. Studies have shown the clinical advantages of skin stretching systems, however, quantitative bioengineering models, demonstrating closure of large wounds, are lacking. Here we present finite element (FE) modeling of the TopClosure® tension relief system (TRS) and its biomechanical efficacy in three (real) wound cases, compared with the alternative of a conventional surgical suturing closure technique. Our simulations showed that peak effective stresses on the skin were at least an order of magnitude greater (and sometimes nearly 2 orders-of-magnitude greater) when tension sutures were used with respect to the corresponding TRS data. For the tension suture simulations, the tensile stress was in the range of 415–648 MPa and in the TRS simulations, it was 16–30 MPa. Based on the present computational FE modeling, the TRS reduces localized tissue deformations and stress concentrations in skin and underlying tissues while closing large wounds, compared to the deformations and stresses that are inflicted during the process of suturing. This substantial reduction of loads allows surgeons to better employ the viscoelastic properties of the skin for primary wound closure.