NecorsisNCT04097665
The Use of Indocyanine Green Angiography to Predict Expanded Flap Viability
An observational study of Necorsis, run by Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University at 1 site in China.
Trial summary
It is a prospective and observational trial that designed to evaluate the effect of intraoperative indocyanine green angiography (ICGA) on prediction of postoperative necrosis and other complications in patients treated with expanded flaps. Read more about this study
- Who is it for?
- Ages 5 to 60 years
- Conditions the study is for
- Necorsis
- What is being tested?
- indocyanine green angiography
- Type of treatment
- Injection or infusion, Medical device
- How many people
- 30 participants
- Where
- 1 siteChina
- Study dates
- 18 Nov 2019to 31 Dec 2020
- How long will I take part?
- 7 Days
- Phase
- Observational
- 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 5 to 60 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: Patients who come to the department of plastic and reconstructive surgery in Shanghai ninth people's hospital and undergo tissue expander treatment.
Who may be able to join
- Age: 6-50 years old;
- Sex: male and female;
- Undergo expanded flap treatment;
- Possible to suffer from flap necrosis;
- Sign the informed consent and are willing to keep following up
Who cannot join
- Present or history of significant medical diseases including infectious, renal, cardiovascular, hepatic, hematological and psychiatric diseases;
- Evidence of infection, ischemia, ulcer or other pathological changes within the targeting area which defined as not suitable for expansion; or history of delayed healing, radiational therapy;
- Long history of smoking and/or drinking (>5 years) without quit.
- Iodine allergy; Indocyanine green allergy;
- Evidence of psychological disorders, no self-awareness and unable to cooperate;
- Evidence of malignant diseases or unwillingness to participate.
Trial locations and contacts
1 site in 1 country.
China1 site
Shanghai Ninth People's Hospital
Shanghai, Shanghai Municipality, 200011
About this study
It is a prospective and observational trial that designed to evaluate the effect of intraoperative indocyanine green angiography (ICGA) on prediction of postoperative necrosis and other complications in patients treated with expanded flaps.
Read the detailed description
The lack of suitable soft tissues is a common challenge facing the reconstructive surgeon. Tissue expansion, first described in 1957 by Neumann, is an ingenious technique that can cause body to grow additional skin tissue of similar texture and color to the defect to be repaired and reduce donor site morbidity at the same time. Generally, a silicone balloon expander is inserted under the skin and then gradually filled with saline or carbon dioxide over time, inducing tissue regeneration. Tissue expansion represents one of the major advances in reconstructive surgery and has been widely involved in all kinds of plastic and reconstructive endeavor. In the process of expansion, mechanical stretch also triggers tissue neovascularization and changes in hemodynamic characteristics. These alterations in expanded flap make it challenging to assess flap perfusion and predict postoperative blood flow disorders.
Traditionally, surgeons rely on the clinical experience for determining tissue perfusion, including flap color, capillary refill and pinprick bleeding. However, clinical judgment is highly subjective, difficult to acquire and may be misleading in nonconventional flaps like expanded flaps. Various technologies have been evaluated for perfusion monitoring, including fluorescein angiography, tissue oxygen saturation measurement and thermography. Nevertheless, these are rarely used as routine due to practical limitations, insufficient sensitivity and/or specificity. Recently, Indocyanine Green Angiography (ICGA) has been used for intraoperative evaluation of tissue perfusion. ICGA can give a real-time assessment of flap vascularity and perfusion by intravenously injecting a contrast agent indocyanine green that emits fluorescence when excited by a laser of specific wavelength. Several studies have validated its role in intraoperative evaluation of conventional free and pedicled flap perfusion to aid in surgical decision making and predict postoperative tissue viability. There is obvious difference in hemodynamic characteristics between conventional and expanded flaps so that the conclusion generated from conventional flap study can't be simply extended to expanded flap. In other words, the benefits of ICGA on predicting viability of expanded flaps remains to be validated.
The purpose of this study is to evaluate the effect of intraoperative ICGA on the prediction of flap necrosis in patients underwent tissue expansion. ICGA will be conducted intraoperatively, meanwhile, the possible area of necrosis will be marked according to clinical experience and the fluorescence value of each observation point will be recorded. After 1 week's follow up, the flap viability at each observation point will be assessed by clinical examination. Then, the corresponding fluorescence value will be determined by superimposing digital photography over ICGA imaging results. By analyzing the observation point representing different fate of flap tissue with Logistic regression analysis, ROC curve and area under curve (AUC) can be synthesized by SPSS. A cut-off point can be further identified to achieve both higher positive and negative predictive value, improving the utility and accuracy of ICGA in predicting the postoperative skin viability of expanded flaps.
- Conditions
- Necorsis
- Being tested
- indocyanine green angiography
- Keywords
- ICGA, necrosis, blood supply, expanded flap
- Medical subject headings
- Necrosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
indocyanine green angiographyDevice
Also called ICGA
All patients treated with expanded flaps will be assessed by surgeons, and the possible area of necrosis will be marked based on clinical experience. This area will be further divided into perfusion units (1*1 square centimeter for each), and the center of each perfusion unit will be marked. Then all patients will receive ICGA after the complete transfer of flap to the recipient site. For ICGA, a 2ml bolus of indocyanine green (2.5mg/ml) was injected through the patient's intravenous line. The detector/camera of the SPY imaging system should place over the flap at approximately 30cm for fluorescence image acquisition. The fluorescence value will be recorded afterwards.
| Study group | Role | What they receive |
|---|---|---|
| patients with expanded flaps | Patients will undergo tissue expansion. When the expanded flaps are harvested and transplanted, ICGA will be conducted intraoperatively. Meanwhile, the possible area of necrosis will be marked according to clinical experience. And then this area will be further divided into perfusion units (1*1 square centimeter for each). The center of each perfusion unit will be marked as observation point, of which the fluorescence value will be recorded. After 1 week's follow-up postoperatively, the flap tissue will be determined by superimposing digital photography over ICGA imaging results, and the outcome of each observation point will be recorded. By analyzing the fluorescence value and outcome of each observation point, a cut-off point can be further identified to achieve both higher positive and negative predictive value, improving the utility and accuracy of ICGA in predicting the postoperative skin viability of expanded flaps. Receives: Device: indocyanine green angiography |
What is being measured
The primary outcome is the main question the study is designed to answer.
The number of necrotic and survival observation points and corresponding intraoperative fluorescence values
The clinical outcome of each observation point will be assigned as necrosis or survive 7 days post operation. Necrosis includes epidermolysis, partial/superficial necrosis, and full-thickness necrosis. Partial/superficial necrosis is defined as loss of epidermis and partial loss of dermis with no subcutaneous tissue exposure/no requirement for debridement. Full-thickness necrosis is defined as loss of both epidermis and dermis. The number of necrotic and survival observation points will be recorded respectively, and the intraoperative fluorescence value of each point will be backtracked on SPY-Q afterwards.
Measured: 7 days post-operation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Sep 2019
- Study start18 Nov 2019
- Primary completion31 Dec 2020 (estimated)
- Study completion31 Dec 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (14)Papers the sponsor has linked to this study.
- Other trials for NecorsisStudies of the same condition, open and under way.
- More trials run by Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong UniversityThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 30 participants (estimated)
- Target duration
- 7 Days
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, zantao, Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University
- Investigators
- Tao Zan, MD,PhD, Study director, Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04097665
- Sponsor's protocol ID
- ICGA
- Status last verified
- Dec 2020
- First submitted
- 19 Sep 2019
- Last updated
- 2 Dec 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Singh M, Nuutila K, Kruse C, Robson MC, Caterson E, Eriksson E. Challenging the Conventional Therapy: Emerging Skin Graft Techniques for Wound Healing. Plast Reconstr Surg. 2015 Oct;136(4):524e-530e. doi: 10.1097/PRS.0000000000001634.
PubMed 26397272Parrett BM, Pomahac B, Orgill DP, Pribaz JJ. The role of free-tissue transfer for head and neck burn reconstruction. Plast Reconstr Surg. 2007 Dec;120(7):1871-1878. doi: 10.1097/01.prs.0000287272.28417.14.
PubMed 18090749Cherry GW, Austad E, Pasyk K, McClatchey K, Rohrich RJ. Increased survival and vascularity of random-pattern skin flaps elevated in controlled, expanded skin. Plast Reconstr Surg. 1983 Nov;72(5):680-7. doi: 10.1097/00006534-198311000-00018.
PubMed 6194539Liang X, Huang X, Zhou Y, Jin R, Li Q. Mechanical Stretching Promotes Skin Tissue Regeneration via Enhancing Mesenchymal Stem Cell Homing and Transdifferentiation. Stem Cells Transl Med. 2016 Jul;5(7):960-9. doi: 10.5966/sctm.2015-0274. Epub 2016 Apr 29.
PubMed 27130223Ghali S, Butler PEM, Tepper OM, Gurtner GC. Vascular delay revisited. Plast Reconstr Surg. 2007 May;119(6):1735-1744. doi: 10.1097/01.prs.0000246384.14593.6e.
PubMed 17440348Chiu DT, Hu G, Wu J, Rhee S, Rogers L, Gorlick N. Extended rat-ear flap model: a new rodent model for studying the effects of vessel supercharging on flap viability. J Reconstr Microsurg. 2002 Aug;18(6):503-8. doi: 10.1055/s-2002-33322.
PubMed 12177821Yao ST. Vascular implantation into skin flap: experimental study and clinical application: a preliminary report. Plast Reconstr Surg. 1981 Sep;68(3):404-10. No abstract available.
PubMed 7267814Moyer HR, Losken A. Predicting mastectomy skin flap necrosis with indocyanine green angiography: the gray area defined. Plast Reconstr Surg. 2012 May;129(5):1043-1048. doi: 10.1097/PRS.0b013e31824a2b02.
PubMed 22544087Newman MI, Samson MC, Tamburrino JF, Swartz KA. Intraoperative laser-assisted indocyanine green angiography for the evaluation of mastectomy flaps in immediate breast reconstruction. J Reconstr Microsurg. 2010 Sep;26(7):487-92. doi: 10.1055/s-0030-1261701. Epub 2010 Jun 10.
PubMed 20539977Phillips BT, Lanier ST, Conkling N, Wang ED, Dagum AB, Ganz JC, Khan SU, Bui DT. Intraoperative perfusion techniques can accurately predict mastectomy skin flap necrosis in breast reconstruction: results of a prospective trial. Plast Reconstr Surg. 2012 May;129(5):778e-788e. doi: 10.1097/PRS.0b013e31824a2ae8.
PubMed 22544108Seifalian AM, Stansby G, Jackson A, Howell K, Hamilton G. Comparison of laser Doppler perfusion imaging, laser Doppler flowmetry, and thermographic imaging for assessment of blood flow in human skin. Eur J Vasc Surg. 1994 Jan;8(1):65-9. doi: 10.1016/s0950-821x(05)80123-9.
PubMed 8307219Losken A, Styblo TM, Schaefer TG, Carlson GW. The use of fluorescein dye as a predictor of mastectomy skin flap viability following autologous tissue reconstruction. Ann Plast Surg. 2008 Jul;61(1):24-9. doi: 10.1097/SAP.0b013e318156621d.
PubMed 18580145Li Q, Zan T, Gu B, Liu K, Shen G, Xie Y, Weng R. Face resurfacing using a cervicothoracic skin flap prefabricated by lateral thigh fascial flap and tissue expander. Microsurgery. 2009;29(7):515-23. doi: 10.1002/micr.20640.
PubMed 19308953Sun BK, Siprashvili Z, Khavari PA. Advances in skin grafting and treatment of cutaneous wounds. Science. 2014 Nov 21;346(6212):941-5. doi: 10.1126/science.1253836.
PubMed 25414301
Study at a glance
From the registry record, last updated by the sponsor on 2 Dec 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Use of Indocyanine Green Angiography to Predict Expanded Flap Viability
- ClinicalTrials.gov ID
- NCT04097665
- Acronym / sponsor ID
- ICGA
- Conditions
- Necorsis
- Keywords
- ICGA, necrosis, blood supply, expanded flap
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong UniversityUniversity, hospital or other
- Study start
- 18 Nov 2019 (actual)
- Primary completion
- 31 Dec 2020 (estimated)
- Study completion
- 31 Dec 2020 (estimated)
- First posted
- 20 Sep 2019 (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.
It is a prospective and observational trial that designed to evaluate the effect of intraoperative indocyanine green angiography (ICGA) on prediction of postoperative necrosis and other complications in patients treated with expanded flaps.
Detailed description
The lack of suitable soft tissues is a common challenge facing the reconstructive surgeon. Tissue expansion, first described in 1957 by Neumann, is an ingenious technique that can cause body to grow additional skin tissue of similar texture and color to the defect to be repaired and reduce donor site morbidity at the same time. Generally, a silicone balloon expander is inserted under the skin and then gradually filled with saline or carbon dioxide over time, inducing tissue regeneration. Tissue expansion represents one of the major advances in reconstructive surgery and has been widely involved in all kinds of plastic and reconstructive endeavor. In the process of expansion, mechanical stretch also triggers tissue neovascularization and changes in hemodynamic characteristics. These alterations in expanded flap make it challenging to assess flap perfusion and predict postoperative blood flow disorders.
Traditionally, surgeons rely on the clinical experience for determining tissue perfusion, including flap color, capillary refill and pinprick bleeding. However, clinical judgment is highly subjective, difficult to acquire and may be misleading in nonconventional flaps like expanded flaps. Various technologies have been evaluated for perfusion monitoring, including fluorescein angiography, tissue oxygen saturation measurement and thermography. Nevertheless, these are rarely used as routine due to practical limitations, insufficient sensitivity and/or specificity. Recently, Indocyanine Green Angiography (ICGA) has been used for intraoperative evaluation of tissue perfusion. ICGA can give a real-time assessment of flap vascularity and perfusion by intravenously injecting a contrast agent indocyanine green that emits fluorescence when excited by a laser of specific wavelength. Several studies have validated its role in intraoperative evaluation of conventional free and pedicled flap perfusion to aid in surgical decision making and predict postoperative tissue viability. There is obvious difference in hemodynamic characteristics between conventional and expanded flaps so that the conclusion generated from conventional flap study can't be simply extended to expanded flap. In other words, the benefits of ICGA on predicting viability of expanded flaps remains to be validated.
The purpose of this study is to evaluate the effect of intraoperative ICGA on the prediction of flap necrosis in patients underwent tissue expansion. ICGA will be conducted intraoperatively, meanwhile, the possible area of necrosis will be marked according to clinical experience and the fluorescence value of each observation point will be recorded. After 1 week's follow up, the flap viability at each observation point will be assessed by clinical examination. Then, the corresponding fluorescence value will be determined by superimposing digital photography over ICGA imaging results. By analyzing the observation point representing different fate of flap tissue with Logistic regression analysis, ROC curve and area under curve (AUC) can be synthesized by SPSS. A cut-off point can be further identified to achieve both higher positive and negative predictive value, improving the utility and accuracy of ICGA in predicting the postoperative skin viability of expanded flaps.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 7 Days
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| patients with expanded flaps | – | Device: indocyanine green angiographyPatients will undergo tissue expansion. When the expanded flaps are harvested and transplanted, ICGA will be conducted intraoperatively. Meanwhile, the possible area of necrosis will be marked according to clinical experience. And then this area will be further divided into perfusion units (1*1 square centimeter for each). The center of each perfusion unit will be marked as observation point, of which the fluorescence value will be recorded. After 1 week's follow-up postoperatively, the flap tissue will be determined by superimposing digital photography over ICGA imaging results, and the outcome of each observation point will be recorded. By analyzing the fluorescence value and outcome of each observation point, a cut-off point can be further identified to achieve both higher positive and negative predictive value, improving the utility and accuracy of ICGA in predicting the postoperative skin viability of expanded flaps. |
Who may qualify
- Ages
- 5 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- Patients who come to the department of plastic and reconstructive surgery in Shanghai ninth people's hospital and undergo tissue expander treatment.
Key inclusion criteria (5 listed)
- Age: 6-50 years old;
- Sex: male and female;
- Undergo expanded flap treatment;
- Possible to suffer from flap necrosis;
- Sign the informed consent and are willing to keep following up
Key exclusion criteria (6 listed)
- Present or history of significant medical diseases including infectious, renal, cardiovascular, hepatic, hematological and psychiatric diseases;
- Evidence of infection, ischemia, ulcer or other pathological changes within the targeting area which defined as not suitable for expansion; or history of delayed healing, radiational therapy;
- Long history of smoking and/or drinking (>5 years) without quit.
- Iodine allergy; Indocyanine green allergy;
- Evidence of psychological disorders, no self-awareness and unable to cooperate;
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 |
|---|---|---|
| indocyanine green angiographyAlso: ICGAAll patients treated with expanded flaps will be assessed by surgeons, and the possible area of necrosis will be marked based on clinical experience. This area will be further divided into perfusion units (1*1 square centimeter for each), and the center of each perfusion unit will be marked. Then all patients will receive ICGA after the complete transfer of flap to the recipient site. For ICGA, a 2ml bolus of indocyanine green (2.5mg/ml) was injected through the patient's intravenous line. The detector/camera of the SPY imaging system should place over the flap at approximately 30cm for fluorescence image acquisition. The fluorescence value will be recorded afterwards. | Device | patients with expanded flaps |
Primary outcome
The number of necrotic and survival observation points and corresponding intraoperative fluorescence values
Time frame: 7 days post-operation
The clinical outcome of each observation point will be assigned as necrosis or survive 7 days post operation. Necrosis includes epidermolysis, partial/superficial necrosis, and full-thickness necrosis. Partial/superficial necrosis is defined as loss of epidermis and partial loss of dermis with no subcutaneous tissue exposure/no requirement for debridement. Full-thickness necrosis is defined as loss of both epidermis and dermis. The number of necrotic and survival observation points will be recorded respectively, and the intraoperative fluorescence value of each point will be backtracked on SPY-Q afterwards.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Dec 2020.
- Background: PubMed 26397272Singh M, Nuutila K, Kruse C, Robson MC, Caterson E, Eriksson E. Challenging the Conventional Therapy: Emerging Skin Graft Techniques for Wound Healing. Plast Reconstr Surg. 2015 Oct;136(4):524e-530e. doi: 10.1097/PRS.0000000000001634.
- Background: PubMed 18090749Parrett BM, Pomahac B, Orgill DP, Pribaz JJ. The role of free-tissue transfer for head and neck burn reconstruction. Plast Reconstr Surg. 2007 Dec;120(7):1871-1878. doi: 10.1097/01.prs.0000287272.28417.14.
- Background: PubMed 6194539Cherry GW, Austad E, Pasyk K, McClatchey K, Rohrich RJ. Increased survival and vascularity of random-pattern skin flaps elevated in controlled, expanded skin. Plast Reconstr Surg. 1983 Nov;72(5):680-7. doi: 10.1097/00006534-198311000-00018.
- Background: PubMed 27130223Liang X, Huang X, Zhou Y, Jin R, Li Q. Mechanical Stretching Promotes Skin Tissue Regeneration via Enhancing Mesenchymal Stem Cell Homing and Transdifferentiation. Stem Cells Transl Med. 2016 Jul;5(7):960-9. doi: 10.5966/sctm.2015-0274. Epub 2016 Apr 29.
- Background: PubMed 17440348Ghali S, Butler PEM, Tepper OM, Gurtner GC. Vascular delay revisited. Plast Reconstr Surg. 2007 May;119(6):1735-1744. doi: 10.1097/01.prs.0000246384.14593.6e.
- Background: PubMed 12177821Chiu DT, Hu G, Wu J, Rhee S, Rogers L, Gorlick N. Extended rat-ear flap model: a new rodent model for studying the effects of vessel supercharging on flap viability. J Reconstr Microsurg. 2002 Aug;18(6):503-8. doi: 10.1055/s-2002-33322.
- Background: PubMed 7267814Yao ST. Vascular implantation into skin flap: experimental study and clinical application: a preliminary report. Plast Reconstr Surg. 1981 Sep;68(3):404-10. No abstract available.
- Background: PubMed 22544087Moyer HR, Losken A. Predicting mastectomy skin flap necrosis with indocyanine green angiography: the gray area defined. Plast Reconstr Surg. 2012 May;129(5):1043-1048. doi: 10.1097/PRS.0b013e31824a2b02.
- Background: PubMed 20539977Newman MI, Samson MC, Tamburrino JF, Swartz KA. Intraoperative laser-assisted indocyanine green angiography for the evaluation of mastectomy flaps in immediate breast reconstruction. J Reconstr Microsurg. 2010 Sep;26(7):487-92. doi: 10.1055/s-0030-1261701. Epub 2010 Jun 10.
- Background: PubMed 22544108Phillips BT, Lanier ST, Conkling N, Wang ED, Dagum AB, Ganz JC, Khan SU, Bui DT. Intraoperative perfusion techniques can accurately predict mastectomy skin flap necrosis in breast reconstruction: results of a prospective trial. Plast Reconstr Surg. 2012 May;129(5):778e-788e. doi: 10.1097/PRS.0b013e31824a2ae8.
- Background: PubMed 8307219Seifalian AM, Stansby G, Jackson A, Howell K, Hamilton G. Comparison of laser Doppler perfusion imaging, laser Doppler flowmetry, and thermographic imaging for assessment of blood flow in human skin. Eur J Vasc Surg. 1994 Jan;8(1):65-9. doi: 10.1016/s0950-821x(05)80123-9.
- Background: PubMed 18580145Losken A, Styblo TM, Schaefer TG, Carlson GW. The use of fluorescein dye as a predictor of mastectomy skin flap viability following autologous tissue reconstruction. Ann Plast Surg. 2008 Jul;61(1):24-9. doi: 10.1097/SAP.0b013e318156621d.
- Individual participant dataSharing planned: Undecided
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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.
Tao Zan, MD,PhD study director
Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Necorsis, run by Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University at 1 site in China.
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 5 inclusion and 6 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: status not confirmed, as of the sponsor's last update on 2 Dec 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 China. 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?
Results are not available in the source record.
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?
The number of necrotic and survival observation points and corresponding intraoperative fluorescence values (time frame: 7 days post-operation). 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 NCT04097665, which also lists 14 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 2 Dec 2020; AzTrials last refreshed its copy on 7 Nov 2026.