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Negative Pressure Wound Therapy for Closed Surgical Wounds in Musculoskeletal Oncology Patients - A Case-Control Trial.

ABSTRACT: Following excision of musculoskeletal tumours, patients are at high risk of wound issues such as infection, dehiscence and delayed healing. This is due to a multitude of factors including the invasive nature of the disease, extensive soft tissue dissection, disruption to blood and lymphatic drainage, residual cavity and adjuvant therapies. The use of negative pressure wound therapy (NPWT) has a growing body of evidence on its beneficial effect of wound healing such as promoting cell differentiation, minimising oedema and thermoregulation. Traditionally, these dressings have been used for open or dehisced wounds; however recent research has investigated its role in closed wounds. AIM:To evaluate the effect of NPWT in patients with closed wounds, either primarily or with flap coverage, in our high risk group. Consecutive patients who had a NPWT dressing applied were selected, and a control group was established by a blinded researcher with matching for tissue diagnosis, surgical site, gender and age. The primary outcome measured was documented for wound complications, with secondary data collected on radiotherapy and wound drainage. RESULTS:Patients were well matched between the intervention (n=9) and control (n=9) groups for gender, age and tissue diagnosis. Both groups had 1 patient who underwent preoperative radiotherapy. A total of 3 wound infections occurred in the control group and none in the NPWT group. Overall there was a trend towards lower drain output and statistically significantly reduced infection rate in the NPWT group. CONCLUSION:In this short series, despite the NPWT patients having more additional risk factors for wound issues, they resulted in fewer infections. The sample size is not sufficient to have statistically significant reduction. Further evaluation on the value of NPWT in this patient group should be prospectively evaluated.

SUBMITTER: Kong R

PROVIDER: S-EPMC5481620 | biostudies-literature | 2017

REPOSITORIES: biostudies-literature

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Negative Pressure Wound Therapy for Closed Surgical Wounds in Musculoskeletal Oncology Patients - A Case-Control Trial.

Kong Roderick R Shields David D Bailey Oliver O Gupta Sanjay S Mahendra Ashish A

The open orthopaedics journal 20170531

Following excision of musculoskeletal tumours, patients are at high risk of wound issues such as infection, dehiscence and delayed healing. This is due to a multitude of factors including the invasive nature of the disease, extensive soft tissue dissection, disruption to blood and lymphatic drainage, residual cavity and adjuvant therapies. The use of negative pressure wound therapy (NPWT) has a growing body of evidence on its beneficial effect of wound healing such as promoting cell differentiat ...[more]

PMID: 28694889

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Project description:BackgroundThe majority of surgical wounds are closed (for example with sutures or staples) and so heal by primary intention. Where closure is not possible, or the wound subsequently breaks down, wounds may be left to heal from the bottom up (healing by secondary intention). Surgical wound healing by secondary intention (SWHSI) frequently presents a significant management challenge. Additional treatments are often required during the course of healing, and thus a significant financial burden is associated with treating these wounds. Increasingly, negative pressure wound therapy (NPWT) is used in the management of SWHSI. This wound dressing system provides a negative pressure (vacuum) to the wound, removing fluid into a canister, which is believed to be conducive to wound healing. Despite the increasing use of NPWT, there is limited robust evidence for the effectiveness of this device. A well-designed and conducted randomised controlled trial is now required to ascertain if NPWT is a clinically and cost-effective treatment for SWHSI.MethodsSWHSI-2 is a pragmatic, multi-centre, cross surgical specialty, two arm, parallel group, randomised controlled superiority trial. Adult patients with a SWHSI will be randomised to receive either NPWT or usual care (no NPWT) and will be followed up for 12 months. The primary outcome will be time to healing (defined as full epithelial cover in absence of a scab) in number of days since randomisation. Secondary outcomes will include key clinical events (hospital admission or discharge, treatment status, reoperation, amputation, antibiotic use and death), wound infection, wound pain, health-related quality of life, health utility and resource use.DiscussionGiven the increasing use of NPWT, despite limited high-quality supporting evidence, the SWHSI-2 Trial will provide robust evidence on the clinical and cost-effectiveness of NPWT in the management of SWHSI. The SWHSI-2 Trial opened to recruitment in May 2019 and is currently recruiting across 20 participating centres.Trial registrationISRCTN 26277546 . Prospectively registered on 25 March 2019.

Project description:In August 2010, the Federal Joint Committee (G-BA) decided that negative pressure wound therapy (NPWT) would not be reimbursable in German ambulatory care. This decision was based on reports from the Institute for Quality and Efficiency in Health Care (IQWiG), which concluded that there is no convincing evidence in favor of NPWT. The aim of this diabetic foot study (DiaFu study) is to evaluate whether the clinical, safety and economic results of NPWT are superior to the results of standard wound treatment.The DiaFu study is designed as a national, multicenter, randomized controlled clinical superiority trial with a special focus on outpatient care in Germany. Competent patients in inpatient and outpatient care suffering from a chronic diabetic foot wound for a minimum of four weeks may be included in the study. The trial evaluates the treatment outcome of the application of a technical medical device which is based on the principle of NPWT (intervention group) in comparison to standard moist wound therapy (control group). All treatment systems used in the intervention group bear the symbol of free trade capacity in the European Union (CE mark) and will be operated within normal conditions of clinical routine and according to manufacturer's instructions. Primary endpoints are the time to complete wound healing and the rate of wound healing achieved in each group within the maximum study treatment time of 16 weeks. Primary endpoints will be confirmed by blinded assessment of wound photographs.The DiaFu study will provide solid evidence regarding the efficacy and effectiveness of NPWT until 31 December 2014, the date when G-BA plans to decide on future reimbursement of NPWT in both ambulatory and in-hospital care. The study is designed to comply with all quality requirements of G-BA and IQWiG and will contribute to evidence-based wound care in Germany. The study has been initiated by the statutory health insurance companies in Germany and is co-funded by two manufacturers of NPWT systems.Clinical Trials.gov registration number: NCT01480362 (date of registration: 23 November 2011).German Clinical Trials Register number: DRKS00003347 (date of registration: 22 November 2011).

Dataset Information

Negative Pressure Wound Therapy for Closed Surgical Wounds in Musculoskeletal Oncology Patients - A Case-Control Trial.

Publications

Negative Pressure Wound Therapy for Closed Surgical Wounds in Musculoskeletal Oncology Patients - A Case-Control Trial.

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