FindTrial
Sign In

Changes in skin color at the site of the operation.

Skin flap Necrosis After Knife or Electrocautery in patients undergoing Inguinal Lymph node dissection (SNAKE): a double blind randomized clinical trial. - SNAKE

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2022/04/042283
Enrollment
100
Registered
2022-04-28
Start date
Unknown
Completion date
Unknown
Last updated
2026-01-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: C211- Malignant neoplasm of anal canal Health Condition 2: C609- Malignant neoplasm of penis, unspecified Health Condition 3: C519- Malignant neoplasm of vulva, unspecified Health Condition 4: C447- Other and unspecified malignant neoplasm of skin of lower limb, including hip

Interventions

Intervention1: Knife: Use of knife to elevate inguinal skin flaps. It will take appproximately 5-10 minutes to elevate the flaps. Control Intervention1: current standard practice: Use of electrocauter

Sponsors

Dr Shiv Rajan
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1. Able and willing to give written informed consent 2. Aged 18 years and above 3. Either males or females 4. Histologically confirmed squamous cell carcinoma of Penis, scrotum, vulva, anal canal and cutaneous sites of lower limb requiring inguinal lymph node dissection. 5. Planned elective surgery. 6. Inguinal lymph node dissection either unilateral or bilateral. 7. Inguinal lymph node dissection either superficial or deep 8. Primary closure of skin edges. 9. Eastern Cooperative Oncology Group (ECOG) performance status 0,1and 2.

Exclusion criteria

Exclusion criteria: 1. Patient undergoing simultaneous combined pelvic and inguinal lymph node dissection on same side. 2. Preoperative skin involvement by inguinal lymph nodes. 3. History of previous surgery or radiation at inguinal area. 4. History of autoimmune skin disorder or systemic steroid therapy.

Design outcomes

Primary

MeasureTime frame
1. To compare the proportion of patients developing skin flap necrosis upto 10 days after surgery.Timepoint: Upto Day 10.—

Secondary

MeasureTime frame
1. The extent of skin flap necrosis in the inguinal wound. 2. Inguinal wound Surgical-Site Infection (SSI) during the hospital stay. 3. Hospitalization beyond 10 days because of the inguinal wound-related problems. 4. Re-intervention for Inguinal wound-related problems within 30 days, e.g. secondary suturing, skin grafting or use of another flap for covering the wound. Timepoint: Upto Post operative Day 30—

Countries

India

Contacts

Public ContactDr Shiv Rajan

King Georges Medical University

shivrajan.194@gmail.com8707494914

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026