None listed
Conditions
Brief summary
This research project aims to assess the impact of a wound healing technology (NovoSorb® BTM) on the rate of wound healing in participants who need to undergo minor amputation of their foot. A minor amputation is a procedure which is required to be performed when there is infection or damage to the tissue of the foot which is no longer able to be salvaged or healed without surgery. A minor amputation may involve one or more of your toes or a portion of your foot which has become damaged and is not able to be saved or healed without removal (amputation) of the affected tissue. Ischemia is a condition where parts of the body are starved of blood, which provide oxygen and nutrients for survival, in turn resulting in damage to tissue which can result in wounds. Neuro-ischemia is a condition most often suffered by people with diabetes. This condition affects both the large and small blood vessels in your body, which results in ischemia to tissues. In people with diabetes this condition often affects the blood vessels in their feet which can lead to non-healing wounds. This study seeks to test the ability of the NovoSorb® BTM to heal wounds in people with wounds related to neuro-ischemia. NovoSorb® BTM was originally designed for use in healing wounds in burns patients. The technology has proven useful in helping to heal burns wounds for more than 5 years. This technology is a piece of foam which serves as a scaffold for your healing tissue to grow through. The product is applied by a surgeon in a theatre environment and is left in place until your tissue has grown through the foam scaffold. The foam is specially formulated to slowly dissolve as your healing progresses and your tissue gets stronger. The foam is absorbed by your body and is considered safe and non-toxic. We are seeking to assess whether NovoSorb® BTM helps to heal minor amputation wounds faster and with less risk of infection when compared with current practice (standard wound dressings – negative pressure and antimicrobial dressings). Medications, drugs, and devices must be approved for use by the Australian Federal Government. NovoSorb® BTM is approved in Australia to treat wounds.
Interventions
A randomised control trial, where participants undergoing minor amputation/tissue debridement surgery (index procedure) on their foot will be randomly allocated to one of two groups (interventional trial group outlined below):
i. A trial group who will receive NovoSorb BTM applied to their wound bed post-surgical debridement/revision (per standard protocol) placed into the wound bed and secured with surgical staples or non-dissolvable suture material. A Negative Pressure Wound Therapy (NPWT) (A
A randomised control trial, where participants undergoing minor amputation/tissue debridement surgery (index procedure) on their foot will be randomly allocated to one of two groups (interventional trial group outlined below): i. A trial group who will receive NovoSorb BTM applied to their wound bed post-surgical debridement/revision (per standard protocol) placed into the wound bed and secured with surgical staples or non-dissolvable suture material. A Negative Pressure Wound Therapy (NPWT) (ActiV.A.C™ Therapy System, 3M, San Antonio USA) device will be placed over the NovoSorb BTM to bolster the product into the wound bed and manage wound exudate. The device will be set at -75mmHg continuous negative pressure. NPWT will continue for a total of 14 days, after which conventional wound dressings will be applied. Conventional wound dressings have been described below in the comparator/control field as these serve as the standard of care for all participants. Application of NovoSorb BTM will be delivered via a surgeon (NovoSorb BTM is a product currently employed as part of our wound treatment milieu and therefore all surgeons at FMC have had training and experience in application of this treatment). Post-surgical care will be provided by nursing staff as per protocol, participants will be monitored by members of the research team after surgery. Participants will remain as an inpatient for a minimum of 7 days post index procedure, after which ongoing monitoring will be performed as per protocol by the research team in conjunction with community nursing service and outpatient clinicians. Participants will remain under the governance of the treating surgeon. Adherence to fidelity of the intervention will be monitored via review of the surgical report and inpatient documentation by the research team.
Sponsors
Flinders Medical Centre
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Subjects must fulfill all the following inclusion criteria to be eligible to participate in the study: i) Any patient scheduled to undergo: (1) minor amputation of the lower limb (defined as amputation of any anatomical structure distal of the proximal metatarsals). (2) incision and drainage of infected tissue of the foot. (3) surgical revision of existing wound on the lower limb. (4) surgical revision of previous amputation site. (5) any surgery of the lower limb resulting in significant tissue deficit not able to be closed by primary intention ii) Who has an established or new diagnosis of diabetes as determined by HbA1C >6.5% (48mmol/mol) or as represented by pre-existing prescription of diabetes medication (e.g., insulin or oral hypoglycaemics) iii) Whose wounds are scored a moderate (stage 3) or high (stage 4) risk of lower limb amputation based on their presenting wound condition, extent of infection and most recent perfusion assessment (toe pressures or transcutaneous oximetry) using the Society for Vascular Surgery Wound Ischemia and foot Infection (WIfI) classification system. iv) Provides written informed consent prior to any clinical study procedures being performed. v) Willing to comply with all study procedures and expects to be available for the duration of the study
Exclusion criteria
Subjects will not be included if any one or more of the following conditions exist: i. Patients who live interstate, rural or remote or who are not able to attend the scheduled appointed review time frames. ii. Patients under 18 years of age. iii. Patients who are unable to give informed consent due to language difficulties or physical/mental incapacity. iv. Patients planned for a minor amputation or surgical procedure of the lower limb where the operative wound bed will/has been closed using primary closure methods (suture, staples). v. Patients with known hypersensitivity to any polyurethane components of NovoSorb™ BTM. vi. Patients who are pregnant or nursing an infant.
Outcome results
None listed