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Comparison of Outcomes of Plantar vs Groin Full-Thickness Skin Graft for Correction of Congenital Syndactyly of Hand

10 de junio de 2026 actualizado por: Kainat usman, Sheikh Zayed Medical College

Congenital syndactyly is a condition present at birth in which two or more fingers are joined together. Surgical correction was performed to separate the fingers, improve hand appearance, and support better hand function. After separation of the fingers, a skin graft is often needed to cover the skin defect created during surgery. Full-thickness skin grafts may be taken from different donor sites. The groin has commonly been used as a donor site, but groin skin may differ from hand skin in color and texture. The plantar area of the foot has been considered as an alternative donor site because it may provide better color and texture matching and the donor scar is usually less visible.

This randomized controlled study compared the outcomes of plantar full-thickness skin grafts with groin full-thickness skin grafts in children who underwent surgical correction for congenital simple complete syndactyly of the hand. The study was conducted in the Department of Plastic Surgery, Sheikh Zayed Hospital, Rahim Yar Khan. Children aged 1 to 10 years with congenital simple complete syndactyly who required surgical correction with skin grafting were enrolled after written informed consent was obtained from their guardians. Children with complex syndactyly, associated congenital syndromes, infections, skin diseases, previous surgery on the affected hand, or missing postoperative photographs were not included.

The participants were assigned to one of two treatment groups by sealed opaque envelopes using a lottery method. One group received a plantar full-thickness skin graft, while the other group received a groin full-thickness skin graft. All operations were performed by a consultant plastic surgeon according to standard surgical practice. Postoperative follow-up was carried out at 2 weeks, 4 weeks, and 6 weeks after surgery.

The main purpose of the study was to compare postoperative complications between the two graft methods. These complications included scar contracture, web creep, donor-site hypertrophic scarring, and delayed healing. Scar contracture referred to tightening or shrinking of the graft or surrounding tissues that could limit finger movement or cause deformity. Web creep referred to distal migration of the reconstructed web space after surgery. Donor-site complications included raised or thickened scarring and delayed wound healing. These outcomes were assessed during follow-up visits by a consultant plastic surgeon who was blinded to the treatment group.

Descripción general del estudio

Tipo de estudio

Intervencionista

Inscripción (Actual)

120

Fase

  • No aplica

Contactos y Ubicaciones

Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.

Ubicaciones de estudio

    • Punjab Province
      • Rahim Yar Khan, Punjab Province, Pakistán, 64200
        • Sheikh Zayed Medical College/Hospital

Criterios de participación

Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.

Criterio de elegibilidad

Edades elegibles para estudiar

  • Niño

Acepta Voluntarios Saludables

No

Descripción

Inclusion Criteria:

  • Patients aged 1 to 10 years of either gender with congenital simple complete syndactyly
  • Cases requiring surgical correction with skin grafting.
  • Patients with no prior surgical intervention on the affected hand.

Exclusion Criteria:

  • Patients with complex syndactyly or other systemic conditions, including congenital syndromes, infections and skin diseases
  • Patients with missing postoperative photographs.

Plan de estudios

Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.

¿Cómo está diseñado el estudio?

Detalles de diseño

  • Propósito principal: Tratamiento
  • Asignación: Aleatorizado
  • Modelo Intervencionista: Asignación paralela
  • Enmascaramiento: Ninguno (etiqueta abierta)

Armas e Intervenciones

Grupo de participantes/brazo
Intervención / Tratamiento
Experimental: Group I - Plantar Full-Thickness Skin Graft
Participants assigned to this group received surgical correction of congenital simple complete syndactyly of the hand using a plantar full-thickness skin graft. The graft was harvested from the plantar surface of the foot and used to cover the skin defect created after syndactyly release. Participants were followed postoperatively at 2 weeks, 4 weeks, and 6 weeks for assessment of healing, scar contracture, web creep, donor-site complications, guardian satisfaction, and aesthetic outcome.
Syndactyly release was performed under standard surgical protocol. A full-thickness skin graft was harvested from the plantar surface of the foot and applied to the recipient defect after separation of the fused fingers.
Comparador activo: Group II - Groin Full-Thickness Skin Graft
Participants assigned to this group received surgical correction of congenital simple complete syndactyly of the hand using a groin full-thickness skin graft. The graft was harvested from the groin region and used to cover the skin defect created after syndactyly release. Participants were followed postoperatively at 2 weeks, 4 weeks, and 6 weeks for assessment of healing, scar contracture, web creep, donor-site complications, guardian satisfaction, and aesthetic outcome.
Syndactyly release was performed under standard surgical protocol. A full-thickness skin graft was harvested from the groin region and applied to the recipient defect after separation of the fused fingers.

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Frequency of Scar Contracture
Periodo de tiempo: 2 weeks, 4 weeks, and 6 weeks after surgery
Scar contracture was assessed as abnormal tightening or shrinkage of the graft or surrounding tissue after syndactyly correction, resulting in visible tightness, deformity, or limitation of finger movement at the surgical site. It was graded as none, mild, moderate, or severe according to clinical examination of range of motion and visible contracture. Assessment was performed by a consultant plastic surgeon blinded to the treatment group.
2 weeks, 4 weeks, and 6 weeks after surgery
Frequency of Web Creep
Periodo de tiempo: 2 weeks, 4 weeks, and 6 weeks after surgery
Web creep was assessed as distal migration of the reconstructed web space beyond the expected anatomical location after syndactyly correction. It was evaluated by visual inspection and measurement from the metacarpophalangeal joint crease to the web apex. Web creep was categorized as absent, less than 5 mm, 5 to 10 mm, or more than 10 mm. Assessment was performed by a consultant plastic surgeon blinded to the treatment group.
2 weeks, 4 weeks, and 6 weeks after surgery
Frequency of Donor-Site Hypertrophic Scarring
Periodo de tiempo: 2 weeks, 4 weeks, and 6 weeks after surgery
Donor-site hypertrophic scarring was assessed as a raised, thickened, erythematous, or pruritic scar confined within the boundaries of the original donor-site wound. It was evaluated through visual and tactile examination of the donor site. The outcome was recorded as present or absent. Assessment was performed by a consultant plastic surgeon blinded to the treatment group.
2 weeks, 4 weeks, and 6 weeks after surgery
Frequency of Delayed Healing
Periodo de tiempo: 2 weeks, 4 weeks, and 6 weeks after surgery
Delayed healing was assessed as failure of complete epithelialization of the graft or donor-site wound within more than 3 weeks after surgery, or the presence of wound dehiscence, infection, necrosis, or persistent exudate. The outcome was recorded according to clinical wound examination. Assessment was performed by a consultant plastic surgeon blinded to the treatment group.
2 weeks, 4 weeks, and 6 weeks after surgery

Medidas de resultado secundarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Aesthetic Outcome Score
Periodo de tiempo: 6 weeks after surgery
The aesthetic outcome of the operated hand was assessed using a 1 to 10 score by a consultant plastic surgeon blinded to the treatment group. The score was based on cosmetic appearance, including scar quality, web space appearance, symmetry, and overall visual restoration of the hand. Lower scores indicated poor aesthetic outcome, while higher scores indicated excellent cosmetic outcome.
6 weeks after surgery
Healing Time
Periodo de tiempo: Up to 6 weeks after surgery
Healing time was recorded as the total number of days required for complete epithelialization of the graft and donor-site wounds after surgery.
Up to 6 weeks after surgery
Guardian Satisfaction Score
Periodo de tiempo: 6 weeks after surgery
Guardian satisfaction with the surgical outcome was recorded using a visual analogue scale ranging from 1 to 10. Lower scores indicated poor satisfaction, while higher scores indicated greater satisfaction with the overall surgical outcome, including appearance, function, and healing of the operated hand.
6 weeks after surgery

Colaboradores e Investigadores

Aquí es donde encontrará personas y organizaciones involucradas en este estudio.

Investigadores

  • Investigador principal: Wardah Rehmat, Sheikh Zayed Medical college/Hospital, Rahimyar Khan

Fechas de registro del estudio

Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados ​​por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.

Fechas importantes del estudio

Inicio del estudio (Actual)

1 de marzo de 2025

Finalización primaria (Actual)

31 de diciembre de 2025

Finalización del estudio (Actual)

31 de diciembre de 2025

Fechas de registro del estudio

Enviado por primera vez

10 de junio de 2026

Primero enviado que cumplió con los criterios de control de calidad

10 de junio de 2026

Publicado por primera vez (Actual)

15 de junio de 2026

Actualizaciones de registros de estudio

Última actualización publicada (Actual)

15 de junio de 2026

Última actualización enviada que cumplió con los criterios de control de calidad

10 de junio de 2026

Última verificación

1 de junio de 2026

Más información

Términos relacionados con este estudio

Información sobre medicamentos y dispositivos, documentos del estudio

Estudia un producto farmacéutico regulado por la FDA de EE. UU.

No

Estudia un producto de dispositivo regulado por la FDA de EE. UU.

No

Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .

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