The Use of Indocyanine Green Angiography to Predict Expanded Flap Viability

NCT04097665 | Unknown

• 1 other identifier: ICGA
• Study Type: observational
• Target: 30
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Necorsis

Keywords

ICGA; necrosis; blood supply; expanded flap

Outcome Measures

Primary Outcomes (1)

• 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.

  7 days post-operation

Study Arms (1)

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.

Device: indocyanine green angiography

Interventions

indocyanine green angiography DEVICE

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.

Also known as: ICGA

patients with expanded flaps

Eligibility Criteria

• Age: 5 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Patients who come to the department of plastic and reconstructive surgery in Shanghai ninth people's hospital and undergo tissue expander treatment.

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University: lead

Study Sites (1)

Shanghai Ninth People's Hospital

Shanghai, Shanghai Municipality, 200011, China

Location

Related Publications (14)

• 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.

  PMID: 26397272 BACKGROUND

• Parrett 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.

  PMID: 18090749 BACKGROUND

• Cherry 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.

  PMID: 6194539 BACKGROUND

• Liang 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.

  PMID: 27130223 BACKGROUND

• Ghali 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.

  PMID: 17440348 BACKGROUND

• Chiu 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.

  PMID: 12177821 BACKGROUND

• Yao 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.

  PMID: 7267814 BACKGROUND

• Moyer 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.

  PMID: 22544087 BACKGROUND

• Newman 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.

  PMID: 20539977 BACKGROUND

• Phillips 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.

  PMID: 22544108 BACKGROUND

• Seifalian 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.

  PMID: 8307219 BACKGROUND

• Losken 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.

  PMID: 18580145 BACKGROUND

• Li 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.

  PMID: 19308953 BACKGROUND

• Sun 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.

  PMID: 25414301 BACKGROUND

MeSH Terms

Conditions

Necrosis

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Tao Zan, MD,PhD

  Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 7 Days
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Researcher of Plastic and Reconstructive Surgery

Study Record Dates

• First Submitted: September 19, 2019
• First Posted: September 20, 2019
• Study Start: November 18, 2019
• Primary Completion: December 31, 2020
• Study Completion: December 31, 2020
• Last Updated: December 2, 2020

Record last verified: 2020-12

Locations

CN (1)