Breast ReconstructionNCT04350411
Comparison of PEAK PlasmaBlade™ to Conventional Diathermy in Abdominal Based Free Flap Breast Reconstruction
A study testing Conventional diathermy and PEAK PlasmaBlade™ in people with Breast Reconstruction and Breast Cancer, run by Anglia Ruskin University at 1 site in United Kingdom.
Trial summary
Electrosurgery allows for dissection with simultaneous haemostasis. One of its disadvantages is that the heat production can cause injury to the surrounding tissue which may result in wound healing problems and an increased rate of seromas. Read more about this study
- Who is it for?
- Ages 18 to 80 years, women only
- Conditions the study is for
- Breast Reconstruction, Breast Cancer
- What is being tested?
- Conventional diathermy and PEAK PlasmaBlade™
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 108 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 31 Oct 2016to 31 May 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adults between 18-80 years, able to consent
- Unilateral immediate or delayed DIEP/ MS-TRAM breast reconstruction
- BMI >20
Who cannot join
- Children (<18 years) and adults older than 80 years
- Bilateral or bi-pedicled DIEP/MS-TRAM breast reconstruction
- BMI <20
- Diabetic
- Immune-suppression
- Clotting disorders
Show all 9Show fewer
- On steroid medication
- Pregnancy
- Active smoking
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparison of PEAK PlasmaBlade™ to Conventional Diathermy in Abdominal Based Free Flap Breast Reconstruction - a Single Centre, Double Blinded Randomised Controlled Trial
Electrosurgery allows for dissection with simultaneous haemostasis. One of its disadvantages is that the heat production can cause injury to the surrounding tissue which may result in wound healing problems and an increased rate of seromas.
The PEAK PlasmaBlade™ (PPB) is a new electrosurgery device which may overcome this by having the ability to operate on a lower temperature, therefore reducing collateral thermal damage.
Read more
Different experimental studies in both animal and human models comparing the PEAK PlasmaBlade™ and other surgical dissection devices for incisions have shown a reduction in width of zone of thermal injury, reduction in wound inflammation, increased wound strength and reduced scaring in favour of the PEAK PlasmaBlade™ and comparable to scalpel incisions. A prospective clinical study published by Dogan et al. in 2013, including 46 consecutive breast cancer patients receiving a modified radical mastectomy either with the conventional diathermy (n=22) or the PEAK PlasmaBlade™ (n=24), showed a statistically significant reduction in wound fluid production (p=0.025), leading to earlier drain removal (p=0.020) in the PEAK PlasmaBlade™ group.
Comparable to oncological breast surgery, prolonged drain requirements for high wound fluid production and seromas are often experienced in the abdominal donor side after deep inferior epigastric perforator/ muscle sparing transverse rectus abdominis muscle flap (DIEP/MS-TRAM) breast reconstruction. To evaluate the effects of the PEAK PlasmaBlade™ for abdominal dissection in autologous breast reconstruction on wound fluid production and complications such a seroma, this double blinded randomised controlled clinical trial was conducted.
It was hypothesised the use of the PEAK PlasmaBlade™ for the harvest of the DIEP/ MS-TRAM flap would result in 1) a shorter abdominal drains requirement (days); 2) a lower total drainage volume (mL) from the abdominal drains; 3) lower levels of inflammatory cytokines in the drain fluid and 4) less and smaller seromas would be identified using ultrasound in the follow-up period.
Read the detailed description
The study was conducted between November 2016 and May 2018 in a single centre, St. Andrew's Centre for Plastic Surgery and Burns in Broomfield Hospital, in Chelmsford United Kingdom, including all immediate and delayed DIEP/MS-TRAM patients of two senior plastic surgeons, who agreed to participate and met the in-/exclusion criteria. All participants signed an informed consent. Randomisation was performed using the Trans European Network for Clinical Trials Service (TENALEA), which is an internet-based randomisation system. Patients were either allocated to the 'Group A - diathermy' or 'Group B - PEAK PlasmaBlade™. Blinding was broken after the last patient had completed the 6-week follow-up period.
All patients underwent a standardised DIEP or MS-TRAM breast reconstruction procedure. A scalpel was used to make the skin incision to the depth of the dermis. The raising of the flap was subsequently done either using the PEAK Plasma Blade™ or conventional diathermy. Before the abdominal closure two 15 French Blake drains were inserted and secured to the skin with a 2.0 Silk suture and connected to a low vacuum wound drainage system (85 kPa/neg 100mmHg). Every patient would wear an abdominal binder (9-inch, Marena) for 6 weeks post-operatively. Data on drain requirement, total daily abdominal drainage, pain, mobility and complications were collected during the inpatient stay. On day 0,1 and 2 also abdominal drain fluid was obtained. This was stored in labelled 1.5mL Eppendorf tubes in a -80°C freezer. The samples were sent to Myriad RBM, Inc. a clinical laboratory improvement amendments (CLIA) certified biomarker testing laboratory located in Austin, Texas (United States) for inflammatory cytokine analysis. Abdominal drains were removed when draining 30mL or less in 24 hours. Following discharge, patients were seen in the outpatient department after two and six weeks. At both follow-up appointments, data on complications were recorded. Also an abdominal ultrasound was performed using the V-Universal™ Stand portable ultrasound machine (SonoSite, Inc) to identify and measure abdominal seroma collections. Seromas were only aspirated if they were causing discomfort to the patient. After completion of the 6-week follow-up period patients were discharged from the study. All data were collected by the blinded principle study investigator and logged onto an electronic database.
Data from an in the investigator's unit conducted pilot study on drain requirement was used to perform a power calculation.This results in a minimal sample size of 53 patients for each group (106 overall).
Normal distribution was evaluated using the Shapiro-Wilk test, following this continuous data was analysed using the independent sample t-test or Mann-Whitney U Test to identify a statistically significant difference between the two groups. All right skewed was log transformed, if this resulted in a normal distribution the independent samples t-test was used to determine statistical significance. For categorical data the Pearson Chi-Square Test for numbers over 5 was used. If the count was equal to or less than 5 the Fisher's Exact Test was used to determine statistical significance. A value below or equal to 0.05 (2-tailed) was considered to be statistically significant. Linear regression (Cox proportional hazard model) was used to identify significant determinants for the time to drain removal. Variables that had a significant p-value in the univariate analysis were included in a multivariable analysis. Significant determinants could indicate confounding factors for which would be corrected. Logistic regression was used to identify determinants for complications and the presence of seroma at the 2- and 6-week abdominal ultrasound scan. Variables that had a significant p-value in the univariate analysis were included in multivariable analysis, if none of the determinates were significant p values <0.10 were included in the multivariable analysis. Significant determinants could indicate confounding factors for which would be corrected.
- Conditions
- Breast Reconstruction, Breast Cancer
- Being tested
- Conventional diathermy, PEAK PlasmaBlade™
- Keywords
- Electrosurgery, Conventional diathermy, PEAK PlasmaBlade™, Deep Inferior Epigastric Perforator (DIEP) flap, Drain, Seroma
- Medical subject headings
- Breast Neoplasms, Hyperthermia, Seroma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Conventional diathermyDevice
Abdominal free flap raise performed with conventional diathermy. Settings: cutting 40 Watt, coagulation 40 Watt.
PEAK PlasmaBlade™Device
Abdominal free flap raise performed with PEAK PlasmaBlade™ Settings: cutting 7 (35 Watt), coagulation 7 (35 Watt)
| Study group | Role | What they receive |
|---|---|---|
| Conventional diathermy | Experimental | DIEP/ MS-TRAM breast reconstruction free flap raise performed with conventional diathermy Receives: Device: Conventional diathermy |
| PEAK PlasmaBlade™ | Experimental | DIEP/ MS-TRAM breast reconstruction free flap raise performed with PEAK PlasmaBlade™ Receives: Device: PEAK PlasmaBlade™ |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of days the abdominal drains were required
Number of days post operative
Measured: Drain requirement from the day of operation (day 0) until the day the drain was removed when producing 30ml or less/ 24 hours
Secondary outcomes (10)
Flap raise time
Time required to raise abdominal flap (minutes)
Measured: Data recorded during operation
Weight of abdominal flap
Weight of raised abdominal flap in grams
Measured: Data recorded during operation
Inflammatory markers in abdominal drain fluid on day 0,1 and 2
Inflammatory markers in abdominal drain fluid: TNF-alpha, IL-4, IL-6,IL-8, IL-10, IL-18, MIP-1 alpha, MIP-1 beta, MCP-1
Measured: Drain fluid on day 0, 1 and 2
Pain score
Numerical rating scale (NRS) 0 to 10 (with 0 being no pain and 10 the worse pain imaginable)
Measured: Recorded twice a day (morning and afternoon) while an inpatient (between 3 - 14 days)
Mobility
Number of steps a day
Measured: While an inpatient (between 3 - 14 days)
Total abdominal drain fluid output
Total amount of fluid drained from abdominal wound (millilitres) during admission
Measured: Total amount of abdominal drain fluid collected at time of drain removal (between 3 - 14 days post-operatively)
Complications
Number of complications during the study experienced by each patient (for example: Flap problems, haematoma, delayed abdominal wound healing, seroma)
Measured: In the 6-week follow-up period
Interventions for complications
Number of interventions required to deal with complication for each patient (for example needle aspiration, surgery, iv antibiotics)
Measured: In the 6-week follow-up period
Seroma presence on abdominal ultrasound
Abdominal ultrasound to identify
Measured: At the 2- and 6-week follow-up appointments
Size of seroma collection on abdominal ultrasound
Size (length, width and depth was measured and used to estimate the size using the formula of half an ellipse)
Measured: At the 2- and 6-week follow-up appointments
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Apr 2020
- Study start31 Oct 2016
- Primary completion24 Apr 2018
- Study completion31 May 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Breast ReconstructionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Patients randomised between having their procedure performed with one of two different electrosurgery devices
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 108 participants (actual)
Sponsor and investigators
- Lead sponsor
- Anglia Ruskin University
- Sponsor type
- University, hospital or other
- Collaborators
- Mid Essex Hospital NHS Trust, Medtronic
- Responsible party
- Sponsor
- Investigators
- Thessa R Friebel, MSc, Principal investigator, Mid Essex NHS trustMatthew Griffiths, MBBS, MD, Study director, Mid Essex NHS trustSelim Cellek, MD, PhD, Study director, Anglia Ruskin University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04350411
- Sponsor's protocol ID
- 16/17 086
- Status last verified
- Apr 2020
- First submitted
- 6 Apr 2020
- Last updated
- 17 Apr 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: There is no plan to share the IPD
Publications
Massarweh NN, Cosgriff N, Slakey DP. Electrosurgery: history, principles, and current and future uses. J Am Coll Surg. 2006 Mar;202(3):520-30. doi: 10.1016/j.jamcollsurg.2005.11.017. No abstract available.
PubMed 16500257Yilmaz KB, Dogan L, Nalbant H, Akinci M, Karaman N, Ozaslan C, Kulacoglu H. Comparing scalpel, electrocautery and ultrasonic dissector effects: the impact on wound complications and pro-inflammatory cytokine levels in wound fluid from mastectomy patients. J Breast Cancer. 2011 Mar;14(1):58-63. doi: 10.4048/jbc.2011.14.1.58. Epub 2011 Mar 31.
PubMed 21847396Loh SA, Carlson GA, Chang EI, Huang E, Palanker D, Gurtner GC. Comparative healing of surgical incisions created by the PEAK PlasmaBlade, conventional electrosurgery, and a scalpel. Plast Reconstr Surg. 2009 Dec;124(6):1849-1859. doi: 10.1097/PRS.0b013e3181bcee87.
PubMed 19952641Ruidiaz ME, Messmer D, Atmodjo DY, Vose JG, Huang EJ, Kummel AC, Rosenberg HL, Gurtner GC. Comparative healing of human cutaneous surgical incisions created by the PEAK PlasmaBlade, conventional electrosurgery, and a standard scalpel. Plast Reconstr Surg. 2011 Jul;128(1):104-111. doi: 10.1097/PRS.0b013e31821741ed.
PubMed 21701326Dogan L, Gulcelik MA, Yuksel M, Uyar O, Erdogan O, Reis E. The effect of plasmakinetic cautery on wound healing and complications in mastectomy. J Breast Cancer. 2013 Jun;16(2):198-201. doi: 10.4048/jbc.2013.16.2.198. Epub 2013 Jun 28.
PubMed 23843853
Study at a glance
From the registry record, last updated by the sponsor on 17 Apr 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of PEAK PlasmaBlade™ to Conventional Diathermy in Abdominal Based Free Flap Breast Reconstruction - a Single Centre, Double Blinded Randomised Controlled Trial
- ClinicalTrials.gov ID
- NCT04350411
- Acronym / sponsor ID
- 16/17 086
- Conditions
- Breast Reconstruction, Breast Cancer
- Keywords
- Electrosurgery, Conventional diathermy, PEAK PlasmaBlade™, Deep Inferior Epigastric Perforator (DIEP) flap, Drain, Seroma
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 108 participants (actual)
- Lead sponsor
- Anglia Ruskin UniversityUniversity, hospital or other
- Collaborators
- Mid Essex Hospital NHS Trust, Medtronic
- Study start
- 31 Oct 2016 (actual)
- Primary completion
- 24 Apr 2018 (actual)
- Study completion
- 31 May 2018 (actual)
- First posted
- 17 Apr 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Electrosurgery allows for dissection with simultaneous haemostasis. One of its disadvantages is that the heat production can cause injury to the surrounding tissue which may result in wound healing problems and an increased rate of seromas.
The PEAK PlasmaBlade™ (PPB) is a new electrosurgery device which may overcome this by having the ability to operate on a lower temperature, therefore reducing collateral thermal damage.
Different experimental studies in both animal and human models comparing the PEAK PlasmaBlade™ and other surgical dissection devices for incisions have shown a reduction in width of zone of thermal injury, reduction in wound inflammation, increased wound strength and reduced scaring in favour of the PEAK PlasmaBlade™ and comparable to scalpel incisions. A prospective clinical study published by Dogan et al. in 2013, including 46 consecutive breast cancer patients receiving a modified radical mastectomy either with the conventional diathermy (n=22) or the PEAK PlasmaBlade™ (n=24), showed a statistically significant reduction in wound fluid production (p=0.025), leading to earlier drain removal (p=0.020) in the PEAK PlasmaBlade™ group.
Comparable to oncological breast surgery, prolonged drain requirements for high wound fluid production and seromas are often experienced in the abdominal donor side after deep inferior epigastric perforator/ muscle sparing transverse rectus abdominis muscle flap (DIEP/MS-TRAM) breast reconstruction. To evaluate the effects of the PEAK PlasmaBlade™ for abdominal dissection in autologous breast reconstruction on wound fluid production and complications such a seroma, this double blinded randomised controlled clinical trial was conducted.
It was hypothesised the use of the PEAK PlasmaBlade™ for the harvest of the DIEP/ MS-TRAM flap would result in 1) a shorter abdominal drains requirement (days); 2) a lower total drainage volume (mL) from the abdominal drains; 3) lower levels of inflammatory cytokines in the drain fluid and 4) less and smaller seromas would be identified using ultrasound in the follow-up period.
Detailed description
The study was conducted between November 2016 and May 2018 in a single centre, St. Andrew's Centre for Plastic Surgery and Burns in Broomfield Hospital, in Chelmsford United Kingdom, including all immediate and delayed DIEP/MS-TRAM patients of two senior plastic surgeons, who agreed to participate and met the in-/exclusion criteria. All participants signed an informed consent. Randomisation was performed using the Trans European Network for Clinical Trials Service (TENALEA), which is an internet-based randomisation system. Patients were either allocated to the 'Group A - diathermy' or 'Group B - PEAK PlasmaBlade™. Blinding was broken after the last patient had completed the 6-week follow-up period.
All patients underwent a standardised DIEP or MS-TRAM breast reconstruction procedure. A scalpel was used to make the skin incision to the depth of the dermis. The raising of the flap was subsequently done either using the PEAK Plasma Blade™ or conventional diathermy. Before the abdominal closure two 15 French Blake drains were inserted and secured to the skin with a 2.0 Silk suture and connected to a low vacuum wound drainage system (85 kPa/neg 100mmHg). Every patient would wear an abdominal binder (9-inch, Marena) for 6 weeks post-operatively. Data on drain requirement, total daily abdominal drainage, pain, mobility and complications were collected during the inpatient stay. On day 0,1 and 2 also abdominal drain fluid was obtained. This was stored in labelled 1.5mL Eppendorf tubes in a -80°C freezer. The samples were sent to Myriad RBM, Inc. a clinical laboratory improvement amendments (CLIA) certified biomarker testing laboratory located in Austin, Texas (United States) for inflammatory cytokine analysis. Abdominal drains were removed when draining 30mL or less in 24 hours. Following discharge, patients were seen in the outpatient department after two and six weeks. At both follow-up appointments, data on complications were recorded. Also an abdominal ultrasound was performed using the V-Universal™ Stand portable ultrasound machine (SonoSite, Inc) to identify and measure abdominal seroma collections. Seromas were only aspirated if they were causing discomfort to the patient. After completion of the 6-week follow-up period patients were discharged from the study. All data were collected by the blinded principle study investigator and logged onto an electronic database.
Data from an in the investigator's unit conducted pilot study on drain requirement was used to perform a power calculation.This results in a minimal sample size of 53 patients for each group (106 overall).
Normal distribution was evaluated using the Shapiro-Wilk test, following this continuous data was analysed using the independent sample t-test or Mann-Whitney U Test to identify a statistically significant difference between the two groups. All right skewed was log transformed, if this resulted in a normal distribution the independent samples t-test was used to determine statistical significance. For categorical data the Pearson Chi-Square Test for numbers over 5 was used. If the count was equal to or less than 5 the Fisher's Exact Test was used to determine statistical significance. A value below or equal to 0.05 (2-tailed) was considered to be statistically significant. Linear regression (Cox proportional hazard model) was used to identify significant determinants for the time to drain removal. Variables that had a significant p-value in the univariate analysis were included in a multivariable analysis. Significant determinants could indicate confounding factors for which would be corrected. Logistic regression was used to identify determinants for complications and the presence of seroma at the 2- and 6-week abdominal ultrasound scan. Variables that had a significant p-value in the univariate analysis were included in multivariable analysis, if none of the determinates were significant p values <0.10 were included in the multivariable analysis. Significant determinants could indicate confounding factors for which would be corrected.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
- Model description
- Patients randomised between having their procedure performed with one of two different electrosurgery devices
| Arm | Type | Receives |
|---|---|---|
| Conventional diathermy | Experimental | Device: Conventional diathermyDIEP/ MS-TRAM breast reconstruction free flap raise performed with conventional diathermy |
| PEAK PlasmaBlade™ | Experimental | Device: PEAK PlasmaBlade™DIEP/ MS-TRAM breast reconstruction free flap raise performed with PEAK PlasmaBlade™ |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Adults between 18-80 years, able to consent
- Unilateral immediate or delayed DIEP/ MS-TRAM breast reconstruction
- BMI >20
Key exclusion criteria (9 listed)
- Children (<18 years) and adults older than 80 years
- Bilateral or bi-pedicled DIEP/MS-TRAM breast reconstruction
- BMI <20
- Diabetic
- Immune-suppression
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Conventional diathermyAbdominal free flap raise performed with conventional diathermy. Settings: cutting 40 Watt, coagulation 40 Watt. | Device | Conventional diathermy |
| PEAK PlasmaBlade™Abdominal free flap raise performed with PEAK PlasmaBlade™ Settings: cutting 7 (35 Watt), coagulation 7 (35 Watt) | Device | PEAK PlasmaBlade™ |
Primary outcome
Number of days the abdominal drains were required
Time frame: Drain requirement from the day of operation (day 0) until the day the drain was removed when producing 30ml or less/ 24 hours
Number of days post operative
10 secondary outcomes
Flap raise time
Time frame: Data recorded during operation
Weight of abdominal flap
Time frame: Data recorded during operation
Inflammatory markers in abdominal drain fluid on day 0,1 and 2
Time frame: Drain fluid on day 0, 1 and 2
Pain score
Time frame: Recorded twice a day (morning and afternoon) while an inpatient (between 3 - 14 days)
Mobility
Time frame: While an inpatient (between 3 - 14 days)
Total abdominal drain fluid output
Time frame: Total amount of abdominal drain fluid collected at time of drain removal (between 3 - 14 days post-operatively)
Complications
Time frame: In the 6-week follow-up period
Interventions for complications
Time frame: In the 6-week follow-up period
Seroma presence on abdominal ultrasound
Time frame: At the 2- and 6-week follow-up appointments
Size of seroma collection on abdominal ultrasound
Time frame: At the 2- and 6-week follow-up appointments
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Apr 2020.
- Background: PubMed 16500257Massarweh NN, Cosgriff N, Slakey DP. Electrosurgery: history, principles, and current and future uses. J Am Coll Surg. 2006 Mar;202(3):520-30. doi: 10.1016/j.jamcollsurg.2005.11.017. No abstract available.
- Background: PubMed 21847396Yilmaz KB, Dogan L, Nalbant H, Akinci M, Karaman N, Ozaslan C, Kulacoglu H. Comparing scalpel, electrocautery and ultrasonic dissector effects: the impact on wound complications and pro-inflammatory cytokine levels in wound fluid from mastectomy patients. J Breast Cancer. 2011 Mar;14(1):58-63. doi: 10.4048/jbc.2011.14.1.58. Epub 2011 Mar 31.
- Background: PubMed 19952641Loh SA, Carlson GA, Chang EI, Huang E, Palanker D, Gurtner GC. Comparative healing of surgical incisions created by the PEAK PlasmaBlade, conventional electrosurgery, and a scalpel. Plast Reconstr Surg. 2009 Dec;124(6):1849-1859. doi: 10.1097/PRS.0b013e3181bcee87.
- Background: PubMed 21701326Ruidiaz ME, Messmer D, Atmodjo DY, Vose JG, Huang EJ, Kummel AC, Rosenberg HL, Gurtner GC. Comparative healing of human cutaneous surgical incisions created by the PEAK PlasmaBlade, conventional electrosurgery, and a standard scalpel. Plast Reconstr Surg. 2011 Jul;128(1):104-111. doi: 10.1097/PRS.0b013e31821741ed.
- Background: PubMed 23843853Dogan L, Gulcelik MA, Yuksel M, Uyar O, Erdogan O, Reis E. The effect of plasmakinetic cautery on wound healing and complications in mastectomy. J Breast Cancer. 2013 Jun;16(2):198-201. doi: 10.4048/jbc.2013.16.2.198. Epub 2013 Jun 28.
- Individual participant dataSharing planned: No. There is no plan to share the IPD
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Thessa R Friebel, MSc principal investigator
Mid Essex NHS trust
Matthew Griffiths, MBBS, MD study director
Mid Essex NHS trust
Selim Cellek, MD, PhD study director
Anglia Ruskin University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Conventional diathermy and PEAK PlasmaBlade™ in people with Breast Reconstruction and Breast Cancer, run by Anglia Ruskin University at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Apr 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of days the abdominal drains were required (time frame: Drain requirement from the day of operation (day 0) until the day the drain was removed when producing 30ml or less/ 24 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04350411, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Apr 2020; AzTrials last refreshed its copy on 8 Nov 2026.