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

10 июня 2026 г. обновлено: 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.

Обзор исследования

Статус

Завершенный

Условия

Вмешательство/лечение

Тип исследования

Интервенционный

Регистрация (Действительный)

120

Фаза

  • Непригодный

Контакты и местонахождение

В этом разделе приведены контактные данные лиц, проводящих исследование, и информация о том, где проводится это исследование.

Места учебы

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

Критерии участия

Исследователи ищут людей, которые соответствуют определенному описанию, называемому критериям приемлемости. Некоторыми примерами этих критериев являются общее состояние здоровья человека или предшествующее лечение.

Критерии приемлемости

Возраст, подходящий для обучения

  • Ребенок

Принимает здоровых добровольцев

Нет

Описание

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.

Учебный план

В этом разделе представлена ​​подробная информация о плане исследования, в том числе о том, как планируется исследование и что оно измеряет.

Как устроено исследование?

Детали дизайна

  • Основная цель: Уход
  • Распределение: Рандомизированный
  • Интервенционная модель: Параллельное назначение
  • Маскировка: Нет (открытая этикетка)

Оружие и интервенции

Группа участников / Армия
Вмешательство/лечение
Экспериментальный: 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.
Процедура: Plantar Full-Thickness Skin Graft
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.
Активный компаратор: 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.
Процедура: Groin Full-Thickness Skin Graft
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.

Что измеряет исследование?

Первичные показатели результатов

Мера результата
Мера Описание
Временное ограничение
Frequency of Scar Contracture
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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

Вторичные показатели результатов

Мера результата
Мера Описание
Временное ограничение
Aesthetic Outcome Score
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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

Соавторы и исследователи

Здесь вы найдете людей и организации, участвующие в этом исследовании.

Спонсор

Sheikh Zayed Medical College

Следователи

  • Главный следователь: Wardah Rehmat, Sheikh Zayed Medical college/Hospital, Rahimyar Khan

Даты записи исследования

Эти даты отслеживают ход отправки отчетов об исследованиях и сводных результатов на сайт ClinicalTrials.gov. Записи исследований и сообщаемые результаты проверяются Национальной медицинской библиотекой (NLM), чтобы убедиться, что они соответствуют определенным стандартам контроля качества, прежде чем публиковать их на общедоступном веб-сайте.

Изучение основных дат

Начало исследования (Действительный)

1 марта 2025 г.

Первичное завершение (Действительный)

31 декабря 2025 г.

Завершение исследования (Действительный)

31 декабря 2025 г.

Даты регистрации исследования

Первый отправленный

10 июня 2026 г.

Впервые представлено, что соответствует критериям контроля качества

10 июня 2026 г.

Первый опубликованный (Действительный)

15 июня 2026 г.

Обновления учебных записей

Последнее опубликованное обновление (Действительный)

15 июня 2026 г.

Последнее отправленное обновление, отвечающее критериям контроля качества

10 июня 2026 г.

Последняя проверка

1 июня 2026 г.

Дополнительная информация

Термины, связанные с этим исследованием

Ключевые слова

Другие идентификационные номера исследования

  • Sheikh ZMC/H6

Информация о лекарствах и устройствах, исследовательские документы

Изучает лекарственный продукт, регулируемый FDA США.

Нет

Изучает продукт устройства, регулируемый Управлением по санитарному надзору за качеством пищевых продуктов и медикаментов США.

Нет

Эта информация была получена непосредственно с веб-сайта clinicaltrials.gov без каких-либо изменений. Если у вас есть запросы на изменение, удаление или обновление сведений об исследовании, обращайтесь по адресу register@clinicaltrials.gov. Как только изменение будет реализовано на clinicaltrials.gov, оно будет автоматически обновлено и на нашем веб-сайте. .

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